[Federal Register Volume 62, Number 208 (Tuesday, October 28, 1997)]
[Rules and Regulations]
[Pages 55852-55994]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-26351]



[[Page 55851]]

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Part II





Department of Health and Human Services





_______________________________________________________________________



Food and Drug Administration



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21 CFR Parts 16 and 900



Quality Mammography Standards; Final Rule

  Federal Register / Vol. 62, No. 208 / Tuesday, October 28, 1997 / 
Rules and Regulations  

[[Page 55852]]



DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 16 and 900

[Docket No. 95N-0192]
RIN 0910-AA24


Quality Mammography Standards

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending its 
regulations governing mammography. Amendments are being made to the 
requirements for accreditation bodies; procedures for facility 
certification; and quality standards for mammography personnel, 
equipment and practices, including quality assurance. This action is 
being taken to provide increased assurance of adequate and consistent 
evaluation of mammography facilities on a nationwide level and 
compliance of the facilities with quality standards. It also carries 
out the intent of Congress that FDA replace the existing interim rules 
with more comprehensive final regulations.

DATES: This regulation is effective April 28, 1999; except 
Secs. 900.12(b)(8), 900.12(e)(4)(iii), 900.12(e)(5)(i), 
900.12(e)(5)(iii), and 900.12(e)(5)(x), which become effective October 
28, 2002.

FOR FURTHER INFORMATION CONTACT: Roger Burkhart, Center for Devices and 
Radiological Health (HFZ-240), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20850, 301-594-3332, FAX 301-594-3306.

SUPPLEMENTARY INFORMATION:

I. Background

    The Mammography Quality Standards Act (the MQSA) (Pub. L. 102-539) 
was passed on October 27, 1992, to establish national quality standards 
for mammography. The MQSA required that, to provide mammography 
services legally after October 1, 1994, all facilities, except 
facilities of the Department of Veterans Affairs, shall be accredited 
by an approved accreditation body and certified by the Secretary of 
Health and Human Services (the Secretary). The authority to approve 
accreditation bodies and to certify facilities was delegated by the 
Secretary to FDA.
    The MQSA was enacted in response to the growing incidence of breast 
cancer and its associated mortality rate. Breast cancer is now the most 
common nonskin cancer and is the second leading cause of cancer deaths 
among women, after lung cancer. Early detection of breast cancer, 
typically involving breast physical examination and mammography, is the 
best means of preventing deaths that can result if the diagnosis is 
delayed until the onset of more advanced symptoms. Mammograms can 
reveal breast cancer up to 2 years before a woman or her doctor can 
feel a lump. In addition, over 90 percent of these early stage cancers 
can be cured (Ref. 1).
    However, according to the General Accounting Office (GAO), a 
mammogram is among the most difficult radiographic images to read. It 
must be of high quality for the image to be interpreted correctly. If 
the image quality is poor, the interpreter may miss an incipient 
cancerous lesion. This false negative diagnosis could delay early 
treatment and result in an avoidable death or increased morbidity. It 
is equally true that poor quality images or faulty interpretations can 
lead to a false positive diagnosis when normal tissue is misread as 
abnormal. This can lead to needless anxiety for the patient, costly 
additional testing, and painful biopsies.
    The Senate Committee on Labor and Human Resources held hearings on 
breast cancer in 1992 and found a wide range of problems with 
mammography practice in the United States including: (1) Poor quality 
equipment, (2) a lack of quality assurance procedures, (3) poorly 
trained radiologic technologists and interpreting physicians, and (4) a 
lack of facility inspections or consistent governmental oversight.

A. Provisions of the MQSA

    The MQSA was enacted to address these deficiencies in mammography 
practice. Under the MQSA, Congress established a comprehensive 
statutory scheme for the certification and inspection of mammography 
facilities to ensure that only those facilities that comply with 
minimum Federal standards for safe, high-quality mammography services 
would lawfully continue to operate after October 1, 1994. Operation 
after that date would be contingent on receipt of an FDA certificate 
attesting that the facility meets the mammography quality standards 
issued under section 354(f) of the Public Health Services Act (the PHS 
Act) (42 U.S.C. 263b(f)).
    Specifically, the MQSA required the following:
    (1) Accreditation of mammography facilities by private, nonprofit 
organizations or State agencies that have been approved by FDA as 
meeting the standards established by FDA for accreditation bodies and 
that continue to pass annual FDA reviews of their activities. The MQSA 
also requires that, as part of the overall accreditation process, 
actual clinical mammograms from each facility be evaluated for quality 
by the accreditation body.
    (2) An annual mammography facility physics survey, consultation, 
and evaluation performed by a qualified medical physicist.
    (3) Annual inspection of mammography facilities, to be performed by 
FDA-certified Federal or State inspectors. If State inspectors are 
used, the MQSA requires a Federal audit of the State inspection program 
by direct Federal inspections of a sample of State-inspected 
facilities.
    (4) Establishment of initial and continuing qualification standards 
for interpreting physicians, radiologic technologists, medical 
physicists, and mammography facility inspectors.
    (5) Specification of boards or organizations eligible to certify 
the adequacy of training and experience of mammography personnel.
    (6) Establishment of quality standards for mammography equipment 
and practices, including quality assurance and quality control (QC) 
programs.
    (7) Standards governing recordkeeping for patient files and 
requirements for mammography reporting and patient notification by 
physicians.
    (8) Establishment by the Secretary of a National Mammography 
Quality Assurance Advisory Committee (NMQAAC). Among other things, 
NMQAAC is required to advise FDA on appropriate quality standards for 
mammography facilities and accreditation bodies.
    The MQSA replaced a patchwork of Federal, State, and private 
standards. Its purpose is to guarantee sufficient oversight of 
mammography facilities to ensure that all women nationwide receive 
adequate quality mammography services.

 B.  Interim Regulations

    On December 14, 1993, the President signed legislation (H. Rept. 
2202) granting authority to the Secretary (and by delegation, to FDA) 
to issue temporary interim regulations setting forth standards for 
approving accreditation bodies and establishing quality standards for 
mammography facilities. This authorization was provided in recognition 
of the fact that FDA certification of the approximately 10,000 
mammography facilities in the United States could not be accomplished 
by the October 1, 1994, statutory deadline without streamlining

[[Page 55853]]

the rulemaking process for issuing initial standards. Because of the 
urgent public health need for national mammography standards, Congress 
decided to grant this interim rule authority rather than extend the 
deadline to develop standards.
    In the Federal Register of December 21, 1993 (58 FR 67558 and 58 FR 
67565), FDA issued interim rules establishing requirements for entities 
applying to serve as accreditation bodies and for facilities applying 
to obtain FDA certification in order to continue the legal provision of 
mammography services after October 1, 1994. These interim rules became 
effective on February 22, 1994. They were amended by another interim 
rule published in the Federal Register on September 30, 1994 (59 FR 
49808).

C. Accreditation and Certification

    Operating under the interim regulations, FDA approved the American 
College of Radiology (the ACR) and the State of Iowa as accreditation 
bodies and issued certificates to more than 5,000 facilities accredited 
by these 2 bodies before the October 1, 1994, statutory deadline. Over 
4,500 of the remaining facilities were actively involved in becoming 
accredited on that date. In the fall of 1994, FDA also approved the 
States of Arkansas and California as accreditation bodies.
    In recognition of the fact that a large number of facilities were 
working to meet accreditation standards at the same time, and cognizant 
of the extremely heavy demands this placed upon the accreditation 
bodies, FDA used authority provided by the MQSA to issue 6-month 
provisional certificates on October 1, 1994, to facilities whose 
applications for accreditation were sufficiently complete for review 
and which, on preliminary examination, appeared reasonably likely to 
receive accreditation. This avoided the major reduction in access to 
mammography that would have resulted had several thousand facilities 
been forced to close their doors until the accreditation and 
certification process could be completed.
    By March 31, 1995, the expiration date for the 6-month provisional 
certificates issued on October 1, 1994, over 8,200 facilities had 
become fully accredited and certified. Most of the facilities whose 
accreditation was still in progress satisfied the criteria for the 1-
time 90-day extension of the provisional certificate provided by the 
MQSA and were granted such extensions.
     By June 30, 1995, approximately 9,400 facilities had become fully 
accredited and certified. Several hundred more, primarily facilities 
that had begun operation after October 1, 1994, or facilities that had 
previously failed accreditation and were seeking approval after having 
taken corrective actions, were operating under provisional certificates 
or 90-day extensions of these certificates. FDA estimates that 
approximately 800 facilities closed between October 1993 and June 1995. 
The closings were due to a number of reasons, including failure to 
apply for certification, voluntary closure, and failure to meet the 
standards for accreditation, and other reasons unrelated to the MQSA, 
such as retirement.

D.  Onsite Inspection of Facilities

    At the same time FDA was working with the four accreditation bodies 
to accredit and certify facilities, the agency was also meeting the 
MQSA requirement to establish an annual onsite inspection program to 
monitor facility compliance with the MQSA standards. The bulk of these 
inspections are performed by State inspectors operating under the 
contracts that FDA has with 49 States, Puerto Rico, the District of 
Columbia, and New York City. Federal inspectors inspect Federal 
facilities and facilities in the remaining States and do audits of the 
State inspections. FDA has trained and certified approximately 250 
Federal and State inspectors for this program. All facilities that 
completed the certification process had received their first 
inspections by September 1996 and approximately 70 percent had received 
their second inspections by the end of March 1997. FDA was pleased to 
find widespread compliance with the quality standards during these 
inspections. Only 2 percent of the facilities had one or more of the 
most serious findings (referred to by FDA as Level 1 findings) during 
the first round of inspections and that proportion has dropped to less 
than 1 percent of the facilities inspected so far in the second round.

E. Development of Proposed Regulations

    In granting interim rule authority to FDA, Congress made clear its 
intention that the agency replace the interim regulations with more 
comprehensive regulations as soon as possible. These more extensive 
regulations were to be developed using the normal ``notice and 
comment'' rulemaking process and consultation with the NMQAAC.
    Apart from the strong congressional encouragement, there were also 
other reasons why it was important to replace the existing interim 
regulations for quality mammography with more comprehensive final 
regulations. The interim regulations were based primarily on the 
voluntary standards of the ACR's Mammography Accreditation Program 
(MAP). Utilization of the MAP standards aided greatly in meeting the 
October 1, 1994, deadline for accreditation and certification of 
facilities. The application of these standards to all facilities, 
instead of just those that had sought voluntary accreditation from the 
ACR, had a significant impact on mammography nationwide. However, the 
MAP provisions did not cover all areas that required standards under 
the MQSA, such as mammography of patients with breast implants and 
experience requirements for some personnel of mammography facilities. 
Furthermore, in many situations where MAP voluntary standards were 
relevant, their wording needed to be changed and clarified for use as 
part of a regulatory program.
    One especially significant gap was in the equipment area where the 
standards under the interim regulations were minimal. To provide 
greater assurances of quality equipment performance, the ACR, with the 
Centers for Disease Control and Prevention (CDC), had previously 
convened expert committees to develop specifications for mammography 
equipment. The reports of these expert committees were an important 
basis for the equipment provisions of the proposed regulations.
    In addition, the interim standards were required to be issued and 
implemented prior to FDA developing any significant experience 
regulating mammography. Because the statute was new and the regulatory 
scheme it established presented a different and innovative approach, 
the agency would inevitably develop ideas for improvement in quality 
and efficiency of implementation as the program developed.
    For all of these reasons, it was necessary to replace the interim 
regulations with more comprehensive final regulations in order to 
obtain the highest quality mammography that is reasonably achievable. 
Coincident with the implementation of the interim rules, work was 
proceeding on the development of final regulations. This effort was 
aided by the agency's ongoing experience under the interim rules and 
the advice of members of the NMQAAC. The NMQAAC membership includes 
health professionals whose work focuses significantly on mammography 
and representatives of consumer groups. NMQAAC was chartered on July 7,

[[Page 55854]]

1993. Nominations for members were accepted until September 7, 1993. 
The first meeting of the NMQAAC was held February 17 through 18, 1994. 
At that meeting, and in subsequent meetings in April, July, and 
September 1994, the NMQAAC reviewed and commented on drafts of portions 
of the proposed regulations developed by FDA. At its January 1995 
meeting, the NMQAAC reviewed the entire body of draft proposed 
regulations. Many of the requirements in the proposed regulations were 
based on advice obtained from the members of NMQAAC during these 
meetings.
    Another valuable resource utilized by FDA in the development of the 
proposed regulations was the guideline entitled, Quality Determinants 
of Mammography (Ref. 2). This guideline was developed by the Quality 
Determinants of Mammography Panel, with support from the Agency for 
Health Care Policy and Research (AHCPR), to help eliminate low quality 
mammography and, thereby, eliminate the adverse consequences it causes. 
The Panel consisted of a diverse group representing many medical 
specialties and consumer representatives knowledgeable about 
mammography.
    Proposed regulations were published in the Federal Register of 
April 3, 1996 (61 FR 14856). To facilitate review by the public, they 
were published in 5 separate documents, as described in the 
introduction to section III of this document.

F.  Development of the Final Regulations

    A 90-day public comment period ending July 3, 1996, was provided 
for the proposed regulations. During that time, extensive efforts were 
made to encourage public comments. Approximately 17,000 copies of the 
proposed regulations were mailed to the organizations and individuals 
on FDA's MQSA mailing list, including 1 to every certified mammography 
facility. The availability of the proposal was announced in Mammography 
Matters, the newsletter of FDA's Division of Mammography Quality and 
Radiation Programs (DMQRP), and in the newsletters of professional 
groups. Copies were also distributed by FDA personnel at professional 
meetings. By the end of the comment period, approximately 1,900 
responses, containing approximately 8000 individual comments, had been 
received from organizations and individuals. NMQAAC also provided 
additional comments on the proposal during an April 1996 meeting.
    Analysis of the many comments began after the end of the comment 
period. At the October 1996 meeting, FDA consulted the NMQAAC for 
advice with respect to some of the more controversial issues raised by 
the comments. During the January 1997 meeting, the Committee reviewed 
the entire set of regulations in light of the comments received. The 
public comments and the advice received from the NMQAAC were used to 
develop a draft of final regulations, which the members of the NMQAAC 
had an opportunity to review individually in March 1997.
    The majority of the final regulations will become effective April 
28, 1999. The interim rules will continue to apply until that date. 
Certain equipment-related regulations, in Sec. 900.12(b) and (e), will 
become effective October 28, 2002. This delay in the effective date for 
certain equipment requirements is intended to minimize the costs 
associated with equipment improvements. The cost savings are achieved 
by permitting facilities to implement the improvements as they follow 
their normal equipment replacement schedule instead of requiring an 
immediate purchase of new equipment or equipment upgrades.

II. Highlights of the Final Rule

    This section highlights the major features of the final 
regulations, as compared to the interim and the proposed regulations, 
and their potential for achieving the MQSA goals of establishing 
nationwide quality standards for mammography, while maintaining a broad 
patient access to mammography services. A detailed discussion of the 
public comments and FDA's response to them is provided under section 
III of this document.
    These final regulations fulfill FDA's responsibility under the MQSA 
to establish national quality standards for mammography services, with 
extensive input from NMQAAC. These Federal regulations will be 
implemented under the MQSA framework whereby mammography facilities are 
accredited once every 3 years by FDA-approved State or private not-for-
profit accreditation bodies, and inspected once every year by FDA-
trained and certified State (or in some cases Federal) inspectors. The 
Federal-State-private sector partnership provides the necessary tools 
to successfully implement these regulations and realize the MQSA's goal 
of assuring high quality mammography services for every American woman.
    Accordingly, these regulations establish rigorous criteria designed 
to enhance the quality of mammography services in a manner that is 
reasonably achievable by mammography facilities. The regulations 
provide facilities with flexibility in needed areas to meet the 
important public health goals of these standards. Taken as a whole, the 
regulations are expected to provide substantial consumer benefits in a 
reasoned and cost-effective manner.
    The final regulations consist of two subparts. Subpart A is 
composed primarily of the requirements to be met by the accreditation 
bodies who perform the crucial initial screening of mammography 
facilities for quality, including clinical image review, subpart B 
establishes quality standards to be met by the mammography facilities 
and administrative procedures.

A. Accreditation Body Requirements

    The final regulations refine and codify policies FDA had developed 
under the interim regulations for the initial approval of accreditation 
bodies by FDA, and for defining the ongoing responsibilities of these 
bodies and the agency's oversight of them. The primary goal of the 
accreditation body requirements is to ensure that there is nationwide 
consistency, both within and between accreditation bodies, in the 
evaluation of mammography units and procedures to determine if they 
meet the standards for quality mammography.
    The major change made from proposed Secs. 900.3 through 900.7 was 
the removal of several provisions that would have assigned compliance 
responsibilities to the accreditation bodies. Removal of these 
provisions ensures that the activities of the accreditation bodies will 
have their proper focus, which is to identify facilities that are not 
performing adequate quality mammography and to advise such facilities 
on the nature of their problems and how to correct them. Compliance 
activities under the MQSA are reserved for FDA.

B.  Facility Quality Standards

1. Personnel Standards
    The personnel standards of Sec. 900.12(a) cover interpreting 
physicians, radiologic technologists, and medical physicists who 
provide services to mammography facilities. The goals of the standards 
are to ensure that personnel: (1) Have general qualifications in 
radiology; (2) possess specific qualifications in mammography; and (3) 
keep their qualifications up-to-date.
    Most of the proposed changes in the personnel area were intended to 
clarify general statements in the interim regulations that have caused 
confusion in interpretation. A major step to improve quality of 
personnel

[[Page 55855]]

performance, however, was the proposed establishment of initial and 
continuing experience requirements for radiologic technologists and 
medical physicists. These requirements are parallel to requirements 
already in the interim regulations for physicians and, like the 
physician requirements, are intended to make sure that individuals have 
supervised clinical experience before they begin to provide mammography 
services independently, and that they maintain their skills through 
regular performance of their duties. These new experience requirements 
have been codified in the final rule after some adjustments in the 
amount of experience required due to practical considerations, such as 
the difficulties that medical physicists under contract to one facility 
would face in attempting to meet the proposed requirement to do surveys 
in several facilities.
    Another significant change from the proposed personnel standards is 
that the final rule ``grand parents'' technologists who met the 
personnel requirements under the interim regulations. Without grand 
parenting technologists already in the system, there was the 
possibility that localized shortages of technologists would occur, 
resulting in a serious, short-term impact on access to mammography. 
Because the agency believes that most technologists presently providing 
mammography services either meet, or have qualifications comparable to 
the final requirements, grand parenting could be permitted to relieve 
these concerns without any significant impact on quality.
2. Equipment
    The equipment standards in Sec. 900.12(b) are intended to ensure 
that mammography equipment has the capability of producing quality 
mammograms over the full range of clinical conditions. The equipment 
area was addressed only briefly in the interim regulations. To better 
define the equipment capabilities needed for high quality mammography, 
equipment specification standards were proposed for all equipment 
components of the mammography system from the X-ray generator to the 
view box. These proposals relied heavily upon the recommendations of 
the equipment focus groups convened in the early part of the decade by 
the ACR, with the support of CDC.
    After reviewing the information provided in the public comments and 
by the NMQAAC, FDA revisited the question of the proper balance between 
the economic impact of new standards and the associated gains to the 
public health. This reconsideration led the agency to conclude that the 
expected benefits from some of the proposed equipment specifications 
would not compensate for the cost to replace or retrofit mammography 
systems to meet them. The agency has concluded that, in some cases, the 
same public health goals could be accomplished through specified 
quality assurance procedures. Accordingly, specifications related to 
source-image receptor distance (SID), focal spot location, filtration, 
and film processors have been eliminated and specifications related to 
compression and radiation output are being treated as performance 
standards under the quality assurance section of the regulations. 
Similarly, performance outcome aspects of the requirements for 
alignment have been moved to the quality assurance section. Finally, 
requirements related to system resolution were eliminated as 
duplicating performance standards already in the quality assurance 
section, and the requirements related to the examination of disabled 
patients were eliminated in part because of a lack of consensus about 
the need for such requirements.
    In an effort to reduce costs, FDA is phasing in the equipment 
requirements, with some becoming effective the same time (18 months) as 
the rest of the regulations and others within 5 years. However, based 
on the desire not to impede technological advances, the uncertainty in 
estimating needs further in the future, and an assessment of the 
associated costs, the agency has eliminated the proposed 10-year phase-
in requirements and some of the 5-year phase-in requirements. The 
agency intends to reassess the need for the deleted requirements at a 
future time.
3. Recordkeeping and Reporting Requirements
    The recordkeeping and reporting requirements of Sec. 900.12(c) are 
intended to: (1) Ensure that all patients and their referring 
physicians receive timely and adequate notification of the results of 
examinations, and (2) assist in diagnosis by ensuring that records of 
past examinations, including the original mammograms, are available 
when needed for comparison with the images produced during new 
examinations.
    With respect to patient notification of examination results, the 
final rule codified this essential reporting requirement as a 
performance outcome standard. The proposed rule would have required the 
facilities to have a system to ensure that all patients received 
written notification of their examination results, and further 
specified what should be included in that notification. The final rule 
requires that each facility have a system to ensure that the results of 
each mammographic examination are communicated to the patient in a 
timely manner. Thus, the focus is placed on the desired performance 
outcome, the notification of the patient in a timely manner, and not on 
the method or specific conduit of the notification. Under the final 
rule, the facility has the flexibility to use the method of 
notification that is most effective in its situation and to convey the 
information to the patient that it deems to be most important. In the 
part of the preamble discussing this provision, FDA continues to 
endorse the use of written notification as the most reliable way to 
guarantee that each patient is notified of results and that any 
necessary followup will occur and recommends that facilities follow the 
AHCPR guidelines on direct written notification to all patients. The 
agency also describes other methods that may achieve the desired 
outcome equally well in specific situations.
    With respect to providing patients with original mammograms upon 
request, the final rule was modified to make it clear that the original 
mammograms must be made available to other medical facilities, at the 
patient's request, whether the transfer is permanent or temporary. It 
is expected that this change will end the difficulties in obtaining 
previous original mammograms for comparison with new mammograms (an 
essential aid to diagnosis) that many patients have experienced under 
the interim regulations.
4. Quality Assurance
    The goal of the quality assurance requirements of Sec. 900.12(d), 
(e), and (f) are to ensure that equipment and personnel continue to 
perform at adequate levels. Section 900(d) defines staff 
responsibilities and recordkeeping requirements for the quality 
assurance program, Sec. 900.12(e) establishes equipment QC 
requirements, and Sec. 900.12(f) outlines the requirements for 
mammography medical outcome audits.
    The proposed equipment QC requirements represented a major 
transition towards performance outcome standards. The interim 
regulations had referenced the ACR quality assurance manuals and thus 
specified not only the performance outcomes to be achieved but the test 
procedures to be followed. The proposed rule was intended to establish 
the desired performance outcomes and the required frequency of testing 
at levels nearly identical to those in the interim regulations, but 
sought to give the mammography facilities some

[[Page 55856]]

flexibility in the testing procedures to be used.
    The final rule leaves the testing frequencies and the performance 
outcomes largely unchanged from the proposal, with the exception that 
standards have been added for radiation output, alignment, and 
compression, parameters previously considered under the equipment 
specifications. The provisions related to retesting after equipment 
failure and taking equipment out-of-service until problems are solved 
have also been modified to give the facility more flexibility in 
determining when performance is compromised sufficiently to warrant 
such actions.
5. Medical Outcomes Audit
    A comprehensive mammography medical outcomes audit program can 
ensure that a facility is providing its patients with accurate 
mammography examinations and followup care and has the potential to 
provide the basis for performance outcome standards. However, the 
public comments made it clear that more research is needed before the 
state-of-the-art will be sufficiently advanced to support regulatory 
performance outcome requirements based on audits. FDA did move a step 
beyond the interim requirement that each facility have a system for 
reviewing outcome data by codifying requirements related to the 
analysis of the data collected.
6. Consumer Complaint Mechanism
    Under the interim regulations, accreditation bodies have developed 
mechanisms for addressing consumer complaints about the quality of 
mammography services received. Requirements for such mechanisms have 
been continued in Sec. 900.4(g) of the final regulations. FDA 
recognized, however, that consumer complaints usually can be addressed 
most effectively at the facility level. For this reason, FDA proposed 
to require each facility to develop a system for collecting and 
resolving consumer complaints, with special emphasis placed on the 
resolution of serious complaints. This requirement has been codified 
with little change in Sec. 900.12(h). The accreditation body and FDA 
retain the responsibility for addressing complaints that cannot be 
resolved at the facility level.
7. Alternative Requirements
    The alternative requirements in Sec. 900.18 provide a mechanism for 
implementing advances in mammography that meet quality standards more 
rapidly than would be possible through amending the regulations. This 
mechanism will be used only when the potential public health benefits 
justify such actions.
    This section was incorporated into the proposed rule from the 
interim regulations with little change. Before codification in the 
final rule, the section was modified to give the agency the authority 
to allow an approved alternative to be used by entities other than the 
entity that applied for approval. This change was made in response to 
concerns that it would be an unnecessary duplication of effort for the 
agency and for the applicants if multiple applications were required 
for the approval of the same advance in mammography.
8. Performance Outcomes
    FDA's proposed rule invited comments on the possibility of taking a 
performance outcomes approach to mammography quality standards. 
Suggestions and comments on possible performance outcome indicators 
were also invited. As discussed in more detail elsewhere in this 
document, the consensus of the public comments was that while the 
performance outcome concept was attractive in theory, much additional 
research will be needed before a performance outcome system to ensure 
mammography quality can be issued. The agency agrees with this 
consensus but also believes that it is possible to start moving in that 
direction in certain areas as noted in the previous discussion.

III. Provisions of the Final Rule

    The proposed regulations that published in the Federal Register of 
April 3, 1996, consisted of five separate documents. The first, 
``Quality Mammography Standards; General Preamble and Proposed 
Alternative Approaches'' (61 FR 14856 (Docket No. 95N-0192)): (1) 
Surveyed the history of efforts to implement the MQSA; (2) summarized 
FDA's analysis of the environmental, economic, and paperwork impacts of 
the final regulations; and (3) set out the agency's proposed ``scope'' 
and ``definitions'' sections (Secs. 900.1 and 900.2). In that document, 
the agency also invited public comments on the concept of performance-
based outcomes regulations and the feasibility of recasting the 
proposed design and process requirements into performance-based 
outcomes requirements.
    The second, ``Quality Standards and Certification Requirements for 
Mammography Facilities; General Facility Requirements'' (61 FR 14870 
(Docket No. 93N-0351)), proposed regulations covering a variety of 
areas, including: (1) Applicability (Sec. 900.10); (2) requirements for 
certification (Sec. 900.11); (3) procedures for suspension or 
revocation of accreditation; (4) accreditation body approval; (5) 
facility certificates (Secs. 900.13 and 900.14); (6) the process for 
appealing agency decisions (Sec. 900.15); and (7) an alternative 
requirement process (Sec. 900.18). Some aspects of the facility 
standards were also covered. These included medical records and 
recordkeeping (Sec. 900.12(c)); general quality assurance requirements 
(Sec. 900.12(d)); mammography medical outcome audits (Sec. 900.12(f)); 
mammography of examinees with breast implants (Sec. 900.12(g)); the 
consumer complaint process (Sec. 900.12(h)); and additional clinical 
image review and patient notification (Sec. 900.12(I)).
    The third, ``Proposed Requirements for Accreditation Bodies of 
Mammography Facilities'' (61 FR 14884 (Docket No. 95N-0192)), covered 
the approval, responsibilities, and withdrawal of approval of 
accreditation bodies (Secs. 900.3 to 900.7).
    The fourth, ``Quality Standards and Certification Requirements for 
Mammography Facilities; Personnel Requirements'' (61 FR 14898 (Docket 
No. 95N-0215)), proposed standards to be met by interpreting physicians 
(Sec. 900.12(a)(1)), radiologic technologists (Sec. 900.12(a)(2)), and 
medical physicists (Sec. 900.12(a)(3)) working in mammography 
facilities.
    The fifth, ``Proposed Quality Standards for Mammography Equipment 
Quality Assurance'' (61 FR 14908 (Docket No. 95N-0195)), proposed 
equipment specifications (Sec. 900.12(b)) and requirements for the 
equipment quality assurance program (Sec. 900.12(e)).
    The proposed regulations were published in these five segments to 
facilitate review and make it easier for members of the public to focus 
on the sections of most interest to them. Because the final regulations 
are being issued as a single document, the comments received in 
response to the proposed regulations are addressed as part of this 
single preamble rather than in separate documents relating to each of 
the five proposal documents. General comments are treated first, 
followed by a discussion of the public response to the concept of 
performance outcome requirements and their feasibility. Then comments 
on the individual components of the final regulations are discussed in 
the order that each component appears in the final regulations.
    Finally, the comments on the FDA's analyses of impact are discussed 
in sections V of this document, and section VI covers the Paperwork 
Reduction Act of 1995 provisions. Citations for individual provisions 
of the regulations

[[Page 55857]]

generally have remained the same; the preamble clearly notes any 
instance in which a provision has been codified under a new citation.
    Each of the five proposed regulations was preceded by a preamble 
containing a wide range of information intended as background and 
information for the final regulations. Comments that the agency 
received relating to preamble discussions have been addressed either 
with the general comments or with the specific regulation sections to 
which they are most closely related.

A.  General Comments

    Many comments received on the proposed regulations raised issues or 
concerns that were broader in scope than any specific provision. These 
more general comments are responded to first, before turning to the 
more specific comments.
1. The Overall Value of the Quality Standards
    (Comment 1). A number of the comments stated opposing positions on 
the overall value of the quality standards established by these 
regulations. Seventeen comments supported the quality standards with 
only minor modifications, noting that they would strengthen radiology 
practices and enhance the quality of mammography. Twenty-six comments, 
on the other hand, opposed the quality standards in their entirety. 
Reasons given included concern about costs and the resultant impact on 
access, opposition to the regulation of medicine, a characterization of 
the standards as unnecessary micro-management, belief that more 
stringent standards were unnecessary or ineffective in improving 
quality, and an opposition to ``international'' requirements for 
mammography practice.
    The agency recognizes the need to balance the benefits to be 
achieved from improved quality of mammography with the cost of those 
improvements and the impact such cost might have on access to 
mammography. Congress addressed the concern with that balance in 
drafting the MQSA and has guided the agency in its efforts to implement 
the statute. An independent evaluation of the program performed by GAO 
determined that the interim regulations had a positive effect on the 
quality of mammography without a serious adverse impact on access (Ref. 
2). Although, as previously mentioned, a number of facilities did close 
for various reasons, service from another provider was generally 
available within 25 miles. Newly established facilities have continued 
to be certified, further mitigating any impact on access. Based upon 
its experience with the interim regulations and advice from NMQAAC 
members, FDA believes that the proposed regulations will achieve 
further improvements in quality at a cost that will not impact access 
significantly. The public comments on the proposal led to a further 
refinement of the regulations, including removal of requirements when 
the comments persuaded the agency that the requirement was not 
essential. These changes, and the associated reduction in cost, should 
provide an even more favorable ratio of benefit to cost.
    In answer to concerns about micro-management, many of the specific 
provisions added in the final regulations reflect practices and 
policies that were developed under the interim regulations. These 
policies were developed in response to requests from mammography 
facilities for information on how to meet the requirements of interim 
regulations and are already being followed by most facilities. 
Incorporating these policies into the final regulations gave interested 
parties the opportunity to comment on them. In response to the 
comments, requirements have been refined to achieve the most favorable 
balance between benefit and cost.
    Finally, FDA notes that the system for ensuring quality mammography 
established by the MQSA and these regulations is unique to the United 
States and is not a duplicate of, or related to any international 
requirements or systems established in any other country.
    (Comment 2). Two comments, while apparently not in total opposition 
to the regulations, did express their authors' opinions that the 
personnel and recordkeeping and reporting requirements went ``far 
beyond FDA's medical device mandate.''
    FDA notes that the authors of these comments have overlooked the 
fact that these regulations are issued under the MQSA, which amended 
the Public Health Service Act, not under the Medical Device Amendments 
to the Federal Food, Drug, and Cosmetic Act (the act). The MQSA 
specifically requires the agency to develop standards for personnel 
qualifications and for reporting and recordkeeping (42 U.S.C. 263b(f)).
    (Comment 3). Several comments, while expressing varying degrees of 
support or opposition to the requirements, asked why mammography has 
been singled out for such attention. Some suggested that other diseases 
were as serious or more serious than breast cancer, while one comment 
pointed out that the radiation levels in mammography are quite low.
    Although a case might be made for developing similar programs for 
diagnosis of other diseases, Congress decided that mammography should 
be the subject of this legislation. Congress found the evidence 
sufficiently convincing that breast cancer was a significant public 
health risk that could be reduced by improved mammography and, 
furthermore, that the performance of mammography nationwide was in need 
of improvement. Congress responded with the MQSA, and FDA is carrying 
out the mandate of that statute. FDA agrees with the comment that 
observed that the radiation levels in mammography are much lower than 
they were 20 years ago (largely as a result of a cooperative 
government, industry, and facility effort) and lower than those used in 
many other examinations. However, the primary concerns addressed by the 
MQSA are not radiation levels but poor image quality and 
interpretation.
    (Comment 4). One comment criticized the proposed regulations for 
not sufficiently recognizing local facility condition variations, 
indicating that standards appropriate for some facilities might be 
unduly burdensome to others. In contrast, another comment strongly 
supported the application of uniform standards in both rural and 
nonrural areas. It stated that this would ensure that women in rural 
areas received optimum care.
    FDA believes that all women are entitled to high quality 
mammography, no matter where they live, and so has not issued lesser 
standards for rural areas or any other subset of facilities. The agency 
further notes that the fear that applying uniform minimum standards 
would cause an undue burden to rural facilities is refuted by the 
experience of Michigan, where such uniform standards have been applied 
to all facilities in that State since 1989 (Ref. 3), and by experience 
under the Federal interim regulations.
    (Comment 5). Ten comments stated that ``the regulations and the 
complaint process may confuse the public by bringing up more issues 
than it is necessary for them to be concerned with and confusing the 
role of mammography in the overall diagnosis and treatment of breast 
cancer.''
    The purpose of the MQSA is to ensure adequate quality mammography 
for all patients. If this purpose is achieved, members of the public 
will be able to receive mammography at any facility in the country 
without having to be concerned about the issues covered by the 
regulations. Thus, public

[[Page 55858]]

``confusion'' should decrease rather than increase as a result of these 
regulations. Without additional details, FDA cannot respond further to 
the concern expressed by the comments about confusion over the role of 
mammography. The agency assumes, however, that any such problems could 
be handled through educational efforts.
2. Division of Responsibility
    The MQSA established a system of checks and balances involving the 
interaction of several groups, including FDA, the States, and the 
accreditation bodies. A number of comments expressed varied concerns 
about the division of responsibility established by the proposal.
    (Comment 6). One of these comments stated that oversight and review 
of mammography facilities is the backbone of the MQSA program. Along 
with a second comment, it noted that FDA, not the accreditation bodies, 
should be responsible for enforcement actions.
    FDA agrees with this comment and believes that the final 
regulations clearly give the agency the primary responsibility for this 
function. However, the regulations also establish that the 
accreditation bodies have responsibility for notifying FDA when they 
have information that enforcement actions may be needed and for 
assisting in related investigations.
    (Comment 7). Two comments stated that the regulations should allow 
States to eliminate overlapping functions if they are serving as both 
accreditation bodies and inspection agencies. A third comment stated 
that more leeway should be given to State accreditation bodies, which 
have enforcement capability, than to non-State accreditation bodies. A 
fourth comment recommended eliminating some unspecified requirements if 
a State agency holds both accreditation body status and an inspection 
contract.
    FDA agrees that states that are both accreditation bodies and 
inspection agencies may be able to combine some functions and, in fact, 
some steps have been taken under the interim regulations. However, it 
is important that all facilities meet the same accreditation and 
inspection requirements. The agency believes it is unlikely that any 
requirements pertaining to accreditation bodies or facility standards 
can be eliminated entirely in States with dual status. The need for 
consistency also explains why FDA disagrees with the third comment; 
State accreditation bodies may have enforcement capability under State 
law but this capability could vary greatly from State to State. As the 
author of the fourth comment did not give specific examples of 
requirements to be eliminated, the agency cannot respond further to 
that comment.
    (Comment 8). Three comments suggested that to reduce costs there 
should be one comprehensive system to accomplish all the necessary 
accreditations within any State that already has in place a mechanism 
for accreditation of facilities and licensure of technologists. The 
comment observed that the Federal Government would have to subsidize 
States for this work.
    States are permitted under the MQSA to apply to become FDA-approved 
accreditation bodies (42 U.S.C. 263b(e)(1)(A)) and three States have 
already done so. FDA disagrees that the agency should merely substitute 
existing State accreditation and licensing systems for the MQSA 
standards. States may have widely different accreditation standards 
under their State laws, while the drafters of the MQSA envisioned a 
system that would establish uniform, minimum national standards for all 
mammography facilities. The MQSA, however, expressly permits State laws 
relating to mammography that are more stringent to be issued or to 
remain in effect (42 U.S.C. 263b(m)). Furthermore, the drafters of the 
MQSA did not provide for Federal subsidies for any accreditation body; 
the statute instead expects those bodies to be supported by their 
accreditation fees.
    (Comment 9). One comment recommended the adoption of only one set 
of rules, whether it be established by the State, ACR, or FDA, to 
govern mammography, while a second recommended combining FDA and ACR 
into one ``accreditation body'' to reduce the problems of complying 
with the requirements of both. Another comment objected to FDA 
permitting States to pass additional laws and regulations governing 
mammography in addition to the MQSA requirements. It stated that this 
would prevent the establishment of consistent nationwide standards. 
Another comment objected to the absence of a preemption clause in the 
MQSA, fearing that would lead to overlapping State and Federal 
regulations.
    FDA notes that, within the limits of the authority given to it by 
the MQSA, it has worked towards the goal of one set of rules. The MQSA 
authorizes FDA to establish one set of uniform baseline standards and 
to require that all approved accreditation bodies, including ACR, 
enforce standards substantially the same as these. The agency has taken 
this step. FDA also notes that the Health Care Financing Administration 
(HCFA) has agreed to accept the MQSA regulations and inspections in 
lieu of the regulations and inspection system it had previously 
established to govern mammography under Medicare, thus reducing 
duplication. The MQSA also requires State standards to be at least as 
rigorous as those of FDA. However, as noted by the comment that there 
is no preemption clause in the statute, the MQSA explicitly gives 
States authority to develop additional regulations governing 
mammography, as long as they are more stringent than the MQSA 
requirements (42 U.S.C. 263b(m)). The intention of the MQSA was to 
create a uniform nationwide baseline quality level for mammography, 
while permitting individual States to strive for higher levels. Only 
Congress can make changes in this approach, not FDA.
    (Comment 10). One comment expressed concern that the nature of the 
State/Federal agency relationship may be an impediment to ensuring 
quality mammography. The author cited two GAO reports criticizing the 
oversight of State programs by other Federal agencies. FDA notes that 
the agency has a long history of Federal-State cooperative programs, 
especially with respect to educational efforts and inspections in the 
medical X-ray area, and that, in general, these programs have been very 
successful. As the agency moves into new areas of cooperation with the 
States, it is studying the experiences of other Federal agencies in an 
effort to avoid any difficulties they may have experienced in working 
with the States.
    (Comment 11). One comment recommended that FDA's mammography 
oversight be limited to equipment standards and requiring that 
facilities be accredited and that oversight of the accreditation bodies 
by FDA be reduced. Another comment suggested limiting FDA's oversight 
only to ensuring that facilities are accredited properly by the 
accreditation bodies.
    FDA notes that the MQSA gives FDA far greater responsibilities than 
either of these comments would permit and the regulations are intended 
to help the agency continue to fulfill its obligations under the 
statute.
    (Comment 12). Similarly, two comments made the general 
recommendation that the accreditation bodies be given expanded 
responsibilities. Other comments had more specific opinions, for or 
against, certain expanded responsibilities for the accreditation 
bodies. Two comments stated that the accreditation body should be the 
sole evaluator of the annual physicist survey, with the MQSA inspector 
merely accepting the

[[Page 55859]]

accreditation body's review. A third comment argued, however, that 
valuable information would be lost if the inspector accepted the 
accreditation body's review of the report and a fourth comment agreed 
that, if duplicate review is not cost effective, it would be more 
appropriate for the inspector to review the survey than the 
accreditation bodies. Three comments stated that the accreditation body 
should be responsible for tracking all personnel requirements for a 
facility, while a fourth would give the accreditation body 
responsibility for review of continuing education credentials. 
Similarly, a fifth comment would limit the inspections to review of the 
physicist survey and the QC program, plus taking a phantom image, 
leaving oversight of the other areas to some unspecified group. Another 
comment on the appropriate division of responsibilities stated that FDA 
should not have inspectors performing tests that have already been 
conducted by medical physicists and technologists.
    FDA has utilized, and plans to continue utilizing, the expertise of 
the accreditation bodies to the maximum extent permitted by the 
statute. The agency also realizes that the checks and balances system 
required by the MQSA leads to some duplication of effort between the 
accreditation body and the inspectors or the inspectors and the medical 
physicists. However, one of the weaknesses of the pre-MQSA oversight 
system for mammography was the lack of an onsite evaluation of the 
facility programs by an individual independent of the facility. 
Experience with the interim regulations has demonstrated the value of 
such inspections; the great majority of findings were for situations 
that had not been identified by the accreditation bodies or the medical 
physicists. On the other hand, there is no doubt that the accreditation 
bodies and the medical physicists have prompted the correction of many 
problems before the inspections took place. These activities and 
results demonstrate the strength of the program. The agency believes 
that the drafters of the MQSA were correct in concluding that a checks 
and balances system, involving two or more entities, would be more 
effective in ensuring the continued maintenance of high quality 
mammography than the use of only one entity or the other.
    (Comment 13). Two comments recommended that the information 
obtained by either the accreditation bodies or the inspectors should be 
shared with the other groups to cut down on unnecessary duplication of 
information collection activities or submission requirements for the 
facilities.
    FDA agrees with this comment and the statute itself supports 
elimination of collection of duplicative information (42 U.S.C. 
263b(d)). Under the interim regulations, the agency has been working 
with the accreditation bodies on the electronic exchange of information 
and will continue to do so under the final regulations.
3. Inspections and Inspectors
    A number of the more general comments addressed various aspects of 
the annual and audit inspections.
    (Comment 14). Two comments suggested that the FDA facility 
inspections should be reduced or eliminated in order to reduce the 
costs to facilities or because annual inspections are not needed. A 
third comment urged that inspection frequencies not be included in 
regulations.
    Annual onsite inspections are required by the MQSA (42 U.S.C. 
263b(g)); that requirement cannot be changed by the agency, even if it 
is not in regulations. The agency is evaluating alternative ways for 
conducting inspections in the hopes of reducing costs for facilities.
    (Comment 15). One comment stated that it was inconsistent for FDA 
to inspect every facility every year while the accreditation bodies are 
required to visit a much smaller number of facilities annually. The 
comment further maintained that the MQSA inspections duplicated other 
inspections.
    The FDA inspections and the accreditation body visits serve two 
different purposes. The MQSA inspections, which are required to be 
annual, are intended to ensure that all facilities continue to meet the 
MQSA quality standards. The MQSA requirement that accreditation bodies 
visit a sample of their facilities each year serves an additional 
purpose, which is to have accreditation bodies evaluate their own 
performance and the effectiveness of their accreditation procedures (42 
U.S.C. 263b(e)(4)(A)). In addition, accreditation bodies, at FDA's 
request or on their own authority, will visit facilities that have been 
identified as potential problem facilities for the purpose of 
identifying the problems and assisting the facility in correcting them.
    (Comment 16). Eleven comments suggested that ACR be designated as 
the inspection organization in New Mexico.
    FDA is unable to consider this suggestion because the MQSA 
specifically limits inspectors to Federal or State personnel (42 U.S.C. 
263b(g)).
    (Comment 17). Three comments were concerned about the standards for 
FDA inspectors and two more urged additional training for inspectors. 
Another comment was very complimentary of inspectors in Iowa. Fifteen 
other comments expressed various concerns about the inspection fees.
    These issues are beyond the scope of these regulations, which cover 
requirements for accreditation bodies and quality standards for 
facilities only. FDA has referred these comments directly to the 
components of FDA that deal with inspector training and inspection 
fees.
4. Public Participation in the Process
    (Comment 18). Three comments expressed concern that not enough 
public input has been obtained during the regulation development 
process and suggested that facilities, manufacturers, and personnel 
should be interviewed.
    The NMQAAC is composed of representatives of the mammography 
community and consumer groups and has been a valuable conduit of public 
input during the eight meetings at which it discussed the final 
regulations before and after they were published. Furthermore, each 
meeting included an open session during which members of the public 
could make statements and many individuals took advantage of these 
opportunities. Finally, there were three public comment periods during 
the development of the regulations. The first of these was for comments 
on the interim regulations. A great deal of information was gained for 
use in the development of the final regulations from comments received 
at this time. The second was after preliminary drafts of the equipment 
and medical physicist standards were released and again valuable 
information was obtained from the public. The third opportunity to 
comment was after the publication of the proposed regulations and, as 
previously discussed, approximately 1,900 responses covering every area 
of the regulations were received from a broad spectrum of organizations 
and individuals. FDA believes that the public has had ample opportunity 
to participate in the regulation development and reiterates that this 
public participation had a significant impact on its final form.
    (Comment 19). Another comment recommended prohibiting NMQAAC 
members from also serving on advisory boards or as consultants to 
accreditation bodies in order to avoid the possibility that a limited 
number of people will have disproportionate influence on the program.
    In forming the NMQAAC and its other advisory panels, FDA has 
complied with the Federal Advisory Committee

[[Page 55860]]

Act (the FACA), the agency's implementing regulations at 21 CFR part 
14, and the MQSA. The FACA requires each advisory committee to be 
fairly balanced in terms of the points of view represented and the MQSA 
expressly describes the constituent segments of the affected community 
that are to have representatives on the Committee (42 U.S.C. 263b(n)). 
Because advisory committees enlist the expertise of outside consultants 
to advise the government, it is frequently the case that well-qualified 
members are nationally recognized experts who are also called upon to 
play leadership and consultant roles for private groups. The agency 
does not prohibit such individuals from providing government service if 
the agency determines that such participation is in the best interest 
of the government because the need for such participation outweighs the 
potential conflict of interest. The existence of any potential 
conflicts are stated for the public record at the beginning of each 
advisory committee meeting and panel members who have conflicts on 
particular matters may be prohibited from voting on those issues.
5. Double Reading
    In the preamble to the proposed rule (61 FR 14870 at 14876, April 
13, 1996), FDA noted that one of the comments received on the interim 
regulations suggested that all mammograms be read a second time by a 
second qualified physician. The author of the comment stated that this 
would avoid unnecessary surgery and emotional stress that can arise 
from a false positive reading and the lack of appropriate followup in 
the case of a false negative reading. The agency did not include such a 
requirement in the final regulations but asked for further comments on 
the issue.
    (Comment 20). Twenty four comments argued against a double reading 
requirement, basing their opposition on such reasons as the cost, the 
difficulty of achieving double reading, the delays in reporting to the 
referring physician leading to patient dissatisfaction, and the belief 
that it would be a meaningless exercise and only a few abnormalities 
would be picked up. Comments asserted that the burden would be 
especially great in rural and isolated areas and could reduce access to 
mammography services. Twelve of these comments also questioned where 
the notion of double reading would lead; and would there be a press for 
triple and quadruple reading. One of these comments urged that the 
focus be on training for the first reader so that double reading is not 
necessary. On the other hand, three comments offered strong support for 
the use of double reading and one comment went so far as to say that 
all films should be double read in order to eliminate the trauma and 
psychological stress associated with false positives. One comment 
suggested requiring double reading for all positive mammograms.
    FDA has determined not to include a double reading requirement in 
the final regulations. Double or multi-reading (as it is now called by 
the agency for reasons discussed with the comments on Sec. 900.2) is 
referenced in the regulations only as a way for interpreting physicians 
at low-workload facilities to meet their continuing experience 
requirements. Although this practice is not being required, the 
regulations do not preclude double reading. FDA encourages facilities 
that believe their services will benefit from such procedures to 
establish the practice as a quality assurance measure.
6. The Organization of the Final Regulation
    (Comment 21). A number of comments were extremely critical of the 
organization of the proposal, finding it difficult to read and to see 
the relationship between the five separate divisions, each with its own 
docket number, preamble, and regulatory content. Several of these 
comments stated that information on the organization of the proposal 
should have been provided, while others made suggestions for 
reorganization of the material when it was published as a final 
regulation.
    FDA adopted the method of presentation in the preamble of the 
proposals in an effort to make it easier for readers to focus on the 
provisions that were of most concern to them. Readers interested 
primarily in the personnel requirements, for example, would need 
consider only the fourth division, while those whose concerns were 
primarily equipment-related, could focus on the last division. Although 
the summary section of each of the five divisions identified the 
material being provided in the other divisions, it is clear from the 
comments that further explanation would have been helpful.
    The final regulations are being published in a single document. 
This single document follows the usual Federal Register format of a 
preamble and a regulation section. The regulation section combines the 
regulations from the five divisions of the proposal in numerical order 
from Secs. 900.1 to 900.18, with some sections reserved for later use. 
For the convenience of the reader, a table of contents is provided.
7. Other Comments
    (Comment 22). Additional comments were received on widely varied 
topics. One comment noted that mammography services are provided for 
men and women, and suggested that any mention of ``women'' should be 
replaced by ``women and men.''
    FDA agrees that men are also consumers of mammography services. 
However, because breast disease and diagnosis overwhelmingly affects 
women, that word seems more appropriate. However, the agency notes that 
in the regulations themselves and at many places in the preamble, the 
term ``patient'' is used. FDA believes this terminology addresses the 
comment's concern.
    (Comment 23). Four comments took issue with statements in the 
preamble to the proposed regulations concerning the expected benefits 
from improved mammography and the number of expected deaths from breast 
cancer.
    FDA is aware that several aspects of these issues are unsettled and 
that authorities may draw different conclusions from the same data. 
However, the authors of the comments did not appear to challenge the 
statute's underlying assumption that mammography can be valuable in 
combating a serious public health threat, even though they might 
disagree on the quantification of that value.
    (Comment 24). Three comments urged FDA to delay the final 
regulations until a study of the impact of the interim regulations 
could be conducted to determine what changes were needed or even if the 
MQSA itself were necessary. Congress intended that final regulations be 
in place before October 1, 1994, so that the benefits of improved 
mammography could be realized as soon as possible. Recognizing the 
magnitude of the task, Congress provided FDA with interim rule 
authority that would require regulations to be issued in two steps. The 
first step was the interim regulations, which led to significant 
benefits. Neither Congress nor the agency believes that any further 
delay in completing the second stage and achieving the increased 
benefits of the final regulations can be justified. The agency notes, 
however, that facilities have been operating under the interim rules 
for over 2\1/2\ years and inspections against the interim regulations 
have been occurring for over 2 years. This experience with the interim 
regulations and the problem areas that were identified have contributed 
significantly to the provisions of the final regulations.
    (Comment 25). One comment asked the agency to clarify who makes the 
decisions about the MQSA regulations.

[[Page 55861]]

    FDA assumes that the author is referring to decisions about 
interpretations of the regulations, including decisions about the 
adequacy of particular training programs for mammography personnel. 
These decisions are made primarily in FDA's DMQRP (address above).
    (Comment 26). Four comments expressed concern that the more unique 
mammography regulations become, the greater the likelihood that 
generalists will be forced out of the field.
    Many of the personnel requirements, such as licensing and 
certification, are general requirements of the medical field. In 
addition, Congress determined, and FDA agrees, that mammography is a 
sufficiently unique and difficult examination to require specialized 
training and experience in the production and interpretation of the 
images and in the testing and maintenance of the equipment. However, it 
does not require a full-time mammography practice to meet the 
experience requirements specific to mammography and the specific 
training requirements are only a fraction of what is required for other 
purposes, such as completing a residency program or maintaining 
certification from the American Registry of Radiologic Technologists 
(ARRT). Thus, individuals will be able to meet the MQSA requirements 
without limiting their activities to mammography and so there will 
still be room for generalists.
    (Comment 27). A number of comments expressed a variety of concerns 
about matters outside the scope of these regulations or beyond FDA's 
authority. These concerns included: (1) Questions about the appropriate 
frequency for screening mammography and the levels of Medicare 
reimbursement; (2) a recommendation that a State advisory board be 
created to monitor each State's mammography program; and (3) a concern 
about the perceived domination of medicine by big business. Because 
these comments are beyond the scope of these regulations, these 
comments will not be addressed.

B. Alternative Approaches to Quality Mammography

    Executive Order 12866 requires Federal agencies to identify and 
assess alternative forms of regulation and, where feasible, specify 
performance objectives (performance or outcome-based standards), rather 
than specifying the behavior and manner of compliance that regulated 
entities must adopt (design-specification standards). In addition, 
Executive Order 12866 requires each agency to avoid regulations that 
duplicate other regulations. In response to this Executive Order, under 
Docket No. 95N-0192, in the Federal Register of April 3, 1996 (61 FR 
14856 at 14859) FDA invited comments on the feasibility of developing 
performance-based regulations. Although the agency did not propose 
specific regulations in this area, it did suggest several possible 
performance measures for mammography and requested comments on their 
value and feasibility. The agency also invited the public to suggest 
other performance outcomes that might provide a basis for performance-
based standards. FDA also invited comments on suggestions for other 
possible alternative approaches. While the standards that were proposed 
were not designed to be performance-based standards, there are elements 
of performance requirements throughout the final regulations. For 
example, most of the QC standards in the final regulations are 
performance based. The discussion in the proposal was to consider 
extending such performance criteria to areas not now covered by that 
type of requirement and to make the performance standards that had been 
proposed more general, thereby possibly reducing the burden on 
facilities.
1. General Comments
    (Comment 28). Sixteen comments asserted that the goal of the 
quality mammography efforts by FDA should be to reduce burdens on the 
medical community by not requesting comments and review of additional 
regulations. Some of the comments stated that ACR should be the entity 
designated to define performance standards and that compliance with 
such standards should be voluntary. Five additional comments suggested 
that it was more appropriate for ACR and ARRT to oversee and govern 
mammography quality.
    FDA notes that these comments are in conflict with the statutory 
provisions of the MQSA (42 U.S.C. 263b)), which mandate that the 
government have authority and responsibility to establish standards for 
the performance of quality mammography. However, in carrying out that 
mandate, FDA has solicited and considered comments from the members of 
the mammography community, including comments from ACR, ARRT, and 
members of NMQAAC.
    (Comment 29). Several individual comments addressed the general 
issue of alternative approaches for quality mammography. One comment 
favored FDA's role in establishing and strengthening standards for 
quality mammography. Another suggested that FDA work with volunteers 
who have an interest in alternative compliance options in order to 
learn what is best.
    Although FDA intends to continue to gather ideas and information 
from experts in the field, the agency believes that the opportunity for 
public review and comment on proposed regulations that will affect 
members of the mammography community is the most equitable approach and 
will minimize potential problems of ``standardization without 
representation.''
    (Comment 30). Four comments addressed the issue of FDA establishing 
another set of interim rules, to be in effect while necessary research 
on performance outcomes-based standards was conducted, or simply going 
forward with the final regulations as proposed. These comments 
supported finalizing the proposed regulations and suggested change only 
if new technologies or alternative compliance options are identified at 
a later time.
    Three comments focused on the cost of changing the regulations and 
discouraged change to the final regulations if any additional costs 
were to be borne by the mammography facilities.
    FDA is sensitive to the issue of costs associated with the 
regulations and will keep this issue in mind whenever considering 
changes to the regulations.
    (Comment 31). Two comments expressed concerns that the general aim 
of alternative approaches to achieve compliance would result in 
loopholes that would allow facilities not performing at acceptable 
levels to continue to perform substandard mammography.
    The agency recognizes the importance of issuing performance 
standards that do not allow loopholes. As with provisions that specify 
the manner of compliance facilities must adopt, FDA intends to review 
performance-based approaches for potential gaps that could defeat 
efforts to achieve quality mammography.
    (Comment 32). One comment stated that the ideas presented in the 
alternative approaches section are unworkable and were not discussed 
with the members of NMQAAC.
    FDA acknowledges that NMQAAC did not have the opportunity to 
discuss the alternative approaches material before publication (61 FR 
14856). However, NMQAAC members did have the opportunity to review this 
material and to make comments and recommendations at two meetings after 
the proposal was published.
    Generally, the NMQAAC comments did not support increasing the 
number of performance-based standards at this time. They pointed out 
that the

[[Page 55862]]

proposed regulations were actually a mix of performance- and 
specification-based standards. While NMQAAC agreed that increased 
reliance on performance-based standards might have promise for the 
future, after further research is done, there are insufficient data at 
this time to base the entire set of standards on performance criteria.
    (Comment 33). One comment stated that the current tests specified 
in the existing regulations are more thorough and complete than 
alternative performance approaches that were identified in the preamble 
to the proposed rules. A similar comment stated that the current tests 
should be used by all facilities, with the exception of those 
facilities that might develop improved, innovative strategies or 
methods. The comment recommended that these facilities apply to FDA for 
exemptions to use the innovative strategies or alternative methods. FDA 
notes that a process for accepting and reviewing such applications is 
provided by Sec. 900.18.
    An additional comment expressed support for the intent of Executive 
Order 12866, but at the same time argued that it is in the best 
interests of FDA to be more specific in the final rules about those 
instances where there are multiple methods or procedures to accomplish 
the same task. The comment further stated that it was unclear how the 
agency decided whether to use a performance outcome-based or a design-
based requirement in a particular situation. A second comment expressed 
a similar opinion.
    FDA notes that the comments on performance outcome-based standards 
discussed above and in the following pages point out many difficulties 
at the present time in establishing regulatory requirements to ensure 
quality mammography that are based totally on performance outcomes. 
However, the agency believes that in certain areas, for example, 
quality assurance, performance outcome standards can and should be 
established. In developing standards in a particular area, the agency 
first considered whether it was feasible to ensure quality in that area 
with performance-outcome standards. If it was not possible to issue 
adequate performance-outcome standards in that area, the agency then 
turned to design standards. Along those lines, FDA disagrees with the 
statement in the comment that specific-design standards should always 
be issued in cases where there are multiple ways of adequately 
achieving a particular task or goal. On the contrary, the agency 
believes that performance-outcome standards should be strongly 
considered in such areas in order to give facilities the flexibility to 
chose the method of achieving the goal that bests fits its particular 
circumstances, instead of requiring that all facilities follow the same 
path.
    One other general comment similar to those of NMQAAC, asserted that 
it was premature to try to identify alternative performance-based 
approaches due to inadequate research and testing of these alternative 
methods at this time. Another comment indicated that FDA did not comply 
with Executive Order 12866 because the agency did not make a real 
effort to identify alternative approaches. Similarly, one comment 
argued that the FDA regulations ignored duplication with other 
regulations, although no examples were given.
    FDA notes that it did include a number of possible performance 
outcomes measures in the proposal. There may be other possibilities of 
which the agency is unaware, but the fact that no alternatives were 
suggested by the author of these comments, or in any other comment, 
suggests that few, if any, other options are currently available. FDA 
further notes that the attempt to elicit public comment, 
recommendations, and opinions concerning performance-based standards 
through the proposal will not end its efforts to identify such 
alternatives. FDA is unable to respond to the criticism that its 
efforts duplicate other regulations in the absence of information on 
where the author of the comment believes this has occurred. However, 
HCFA has agreed to set aside its regulations in the mammography area 
and to accept FDA-certified facilities as meeting its requirements for 
reimbursement under Medicare and Medicaid. This eliminated one possible 
source of regulation duplication.
    FDA strongly supports the use of performance standards, however, it 
recognizes that additional research is needed in the scientific 
community before it can support additional regulations based on 
performance outcomes. FDA encourages continued research in this area, 
and will actively work to develop performance standards in the future.
2. Performance Standards and Outcomes Measures Suggested in the 
Proposal
    A large number of comments were received on the various performance 
outcomes measures identified as possible alternatives by FDA. These are 
reviewed in the following narrative in connection with the identified 
alternative.
3. Mammography Medical Outcomes Audit
    (Comment 34). FDA in the preamble to the proposed rules, FDA 
suggested that the results of a mammography medical outcomes audit 
might be used as the basis for a performance-based standard for each 
mammography facility. A significant number of comments expressed 
concerns about one particular aspect of the audit, namely, requirements 
for patient followup that might be necessary to obtain outcomes data. 
The major issues raised were the cost of such followup and the lack of 
evidence that feedback about outcomes improves practitioner 
performance. The authors of the 10 comments believed that individual 
practitioners would never have sufficient cases to calculate meaningful 
statistical outcomes.
    Concerns were also expressed that there were no protections for the 
confidentiality of outcomes data and that medical outcomes-based 
standards could motivate practitioners to avoid challenging or 
difficult cases. Eleven comments expressed objections to any 
performance standard that would require mammography facilities and 
interpreting physicians to collect followup data on films interpreted 
as negative or to require the calculation of statistics relating to 
sensitivity, specificity, or minimal cancer detection rates. One 
comment objected on the basis that requiring the collection of such 
data would imply that standards were required to force physicians to do 
the best possible job and that this was necessary because it was the 
norm for physicians to cheat or be dishonest. One comment expressed the 
view that use of cancer registries to accumulate data for monitoring 
outcomes was clumsy and expensive.
    A related set of comments directed toward use of the positive 
predictive value (PPV) statistic as a measure of quality mammography 
performance was overwhelmingly negative. Nine comments pointed out that 
there are varying definitions of PPV and that this is not a measure 
familiar and understandable to the general public. The general 
consensus was that this statistic was not useful and should not be 
required to be published outside the physician's practice. Six 
respondents argued that it was completely unacceptable to use the 
physician's outcomes data as a measure of performance. Two comments 
expressed the viewpoint that collection of information about PPV was 
not appropriate because it was affected by many factors beyond the 
control of the facility. Three comments vehemently opposed the public 
disclosure of outcomes data, arguing that there would be a high 
likelihood of misinterpretation by the public and incentives for

[[Page 55863]]

facilities to falsify data. Two comments stated that data collection 
and review alone would not have any significant influence on 
radiologists' behavior, and consequently, that collection of 
statistical data was not worth the effort. Finally, one comment agreed 
that it would be valuable to find valid process and outcomes measures 
for mammography but concluded that it would be premature to focus on 
PPV, which is subject to influence by so many factors external to the 
radiologist.
    In contrast to these negative comments on using the results of the 
mammography medical outcomes audit as the basis for performance 
standards, one comment strongly supported the idea of the medical audit 
as the basis for a performance standard and argued for the publication 
of such findings in order to ensure that the public had access to 
information that would allow them to select a reputable institution. 
Another supportive comment asserted that the agency should develop 
performance standards for medical outcomes audit statistics, which 
could then be used to evaluate physician performance. A third 
respondent urged that medical outcomes could and should be used as more 
comprehensive measures of competence and compliance. Another comment 
suggested that standardized values for sensitivity and specificity 
could support a reduction in personnel requirements for facilities that 
met the performance standards for these two statistics. One final 
comment applauded the possibility of change from specification of the 
manner of compliance to specification of performance objectives.
    FDA observes that the majority of the comments received oppose the 
use of the results of the mammography medical outcomes audit as the 
basis for performance-based standards, at least at this time. The 
agency recognizes that the issues of the confidentiality of data 
collected and the limitations of PPV as an indicator of performance, 
and the other problems identified in the comments, are concerns that 
would have to be addressed before the audit could become the basis for 
performance-based standards. The agency has concluded that it is 
premature to establish performance standards based upon the mammography 
medical outcomes audit, primarily because the necessary data to 
establish such standards and to resolve the concerns expressed in the 
comments are not yet available.
    FDA is aware that the National Cancer Institute's Breast Cancer 
Surveillance Consortium (NCI BCSC) has been actively engaged in 
research to understand the full effect of breast cancer screening on 
cancer outcomes through a collaborative effort with academic and 
community-based mammography facilities. Through linkages of data from 
mammography facilities with pathology data on cancer outcomes from 
population-based cancer registries, outcomes data will be correlated to 
interpretation. One of the goals of this research is to help establish 
realistic targets for mammography performance. FDA participates with 
the NCI BCSC and has staff expertise in the medical outcomes audit area 
to further assist standards development of outcomes measures. FDA will 
evaluate results from this research project as well as other projects 
to determine the best approach to promote improved mammography 
performance through performance-based outcome measures. FDA anticipates 
issuing regulations in the future that would have appropriate medical 
outcomes-based measures.
    To this end, facilities are actively encouraged to develop their 
medical audit programs and pursue outcomes-based measures. Information 
to assist facilities in conducting and interpreting the mammography 
medical outcomes audit can be found in the medial literature. In 
addition, in 1994 the Agency for Health Care Policy and Research 
published, ``Quality Mammography: Clinical Practice Guidelines.'' This 
primer has a complete discussion of issues surrounding the medical 
audit and has references to aid facilities. Meanwhile, the suggestions 
contained in the comments to FDA's proposed rule supporting the use of 
the audit as a basis for performance standards will be considered by 
FDA in further efforts to develop performance-based standards. In 
addition, FDA specifically invites comments on this issue for future 
consideration. Please submit comments on this issue to the contact 
person listed above.
4. Performance-based or Proficiency Testing
    With respect to personnel, FDA raised the possibility in the 
proposal that standards based on successfully passing proficiency tests 
might be the basis for replacement of design specification standards 
requiring certain levels of training and experience.
    (Comment 35). The general consensus of 34 comments on proficiency 
testing was that such requirements would be excessive, unnecessary, 
costly, impractical, and duplicative of examinations already in place, 
such as those administered by the American Board of Medical Physics, 
the American Board of Radiology (ABR), and the American Board of Health 
Physics. Twenty comments criticized the use of performance-based 
standards in this area because they asserted that such standards are 
not yet developed to a level where they can substitute for current 
requirements. Two comments stated that it is better if FDA does not 
become involved in personnel performance-based standards as part of the 
MQSA. Rather, continuing medical education (CME) requirements as they 
currently exist should be satisfactory for this part of the education 
process. Three respondents indicated that the term ``performance-based 
testing'' is too vague and could include even such simple things as the 
radiologist's observation of the technologist performing an 
examination.
    After reviewing these general comments and the specific ones that 
are discussed later in this document, FDA has concluded that it would 
be premature to establish general performance standards based on 
proficiency testing because there is no consensus among experts about 
what those standards should be or how they should be measured. The 
topic of proficiency testing for specific professional groups drew a 
number of responses varying in their level of support for such testing. 
Specific comments are noted and discussed as follows:
    a. Proficiency testing for radiologists
    (Comment 36). Proficiency testing for radiologists drew divergent 
responses. Three comments urged that FDA, in collaboration with NMQAAC, 
develop a proficiency test that physicians must pass prior to 
initiating the practice of mammography interpretation. Four additional 
comments favored proficiency testing for radiologists, but only as an 
initial requirement. Thirteen comments indicated unqualified support 
for proficiency testing for physicians. In contrast, five comments 
maintained that board certification could replace proficiency testing 
with intermittent retesting at 5- to 8-year intervals. Such 
examinations could be handled by the accreditation bodies. Another 
comment stated that random clinical image review at the time of the 
MQSA annual inspection could substitute for proficiency testing. Six 
comments agreed with the basic premise that performance evaluation is 
important in order to determine accurate standards but that more time 
is required to determine appropriate testing devices and standards. One 
comment stated that training and experience requirements for 
interpreting physicians should be sufficient and there was no need for 
periodic testing. Similarly, one comment stated that the

[[Page 55864]]

medical audit could function as a proficiency test for radiologists. 
Two comments expressed a total lack of support for proficiency testing, 
arguing that such testing is time consuming, costly, unnecessary, 
redundant, and not done in any other area of medicine. One comment 
stated that periodic proficiency testing is appropriate for 
nonradiologists reading mammograms but not for trained radiologists. In 
lieu of proficiency testing, this comment suggested a special 
certificate as part of designated continuing education courses as a 
simpler way to establish a measure of proficiency. One final comment 
stated that proficiency testing would impose undue hardship on the 
radiologist whose practice is not exclusively devoted to mammography. A 
total of 79 respondents argued that the cost of proficiency testing 
would be too high and that the additional expenses would be passed 
along to consumers.
    FDA observes that support for proficiency testing for interpreting 
physicians is somewhat stronger than for proficiency testing in 
general, but that the majority of respondents still opposed the idea. 
Given the diversity of response to the possible use of proficiency 
testing for radiologists, and the fact that no existing tests were 
identified in the comments, FDA has concluded that it is not in the 
interest of quality mammography to mandate such testing at this time. 
The agency believes that proficiency testing for physicians, if 
feasible at all, would have to undergo further development before it 
could be the basis of a performance standard.
    b.  Proficiency testing for technologists
    (Comment 37). Three respondents stated that proficiency testing 
every 3 to 5 years would be beneficial to technologists. One additional 
comment concurred, but recommended testing every 2 years. Overall, 
however, there was a general lack of support in the comments for 
proficiency testing of technologists.
     Sixty-one comments stated that such testing for technologists 
cannot be conducted objectively and also indicated that the final 
requirements were adequate to ensure the qualifications of 
technologists. Ten additional comments claimed that proficiency testing 
for technologists is impractical because of the lack of established 
criteria and the absence of an appropriate body to administer such 
tests. Three respondents argued that the medical audit served as a 
proxy proficiency test for technologists. Twenty comments stated that 
the proposed continuing education requirements were sufficient and it 
was not necessary to administer recertification examinations. Thirty-
seven comments argued that technologist proficiency testing was 
redundant with the other initial and continuing education requirements.
    One comment stated that at one time, the ARRT had considered adding 
a practical exam to its evaluation of mammography competency but 
deferred doing so until credible analyses would establish that such an 
examination would result in improved quality of performance. Four 
comments stated that proficiency testing for technologists would drive 
technologists away from the field of mammography. One comment expressed 
the view that annual testing was unnecessary because mammography does 
not change that rapidly. Another comment stated that a requirement for 
proficiency testing for technologists would have a negative impact on 
the availability of mammography in rural and mountainous regions. An 
additional respondent argued that the annual requirements for 
technologists are already excessive and the addition of competency or 
proficiency testing would simply raise costs or close mammography 
facilities. Four other comments expressed similar sentiments, stating 
that technologists already have to meet sufficient requirements, and 
the addition of proficiency testing would be excessive. Concerns also 
were raised about who would administer such testing and the method of 
payment. One comment urged that, if proficiency testing became a 
requirement for recertification, it should be offered at no cost to the 
technologist.
    One comment argued that incompetent technologists could pass a 
proficiency test and further stated that proficiency testing was a 
measure of test-taking skills, not of mammographic competency. Two 
comments expressed the point of view that proficiency testing is 
useless and insulting. Several comments stated that recertification, if 
required in addition to continuing education, is redundant, time-
consuming, and costly. These comments asserted that retesting is 
valuable only in instances of significant changes in the mammography 
modality. One comment pointed out that the ARDMS (a sonographer's 
organization not further identified) had tried to offer a practical 
examination, but abandoned the project because it proved too costly. 
The remaining comments were all generally opposed to proficiency 
testing for technologists. One comment suggested that a better way to 
evaluate technologists would be to require performance at a seminar 
that would assess their clinical competence. Another comment concurred 
with this viewpoint, saying that a written exam cannot measure 
competence in a hands-on field such as mammography. Finally, one 
comment argued that further examination is not necessary if the 
technologist remains active in the field of mammography and maintains 
proper licensure.
    The agency is persuaded that regulations requiring such testing 
would be premature. FDA believes some of the objections raised, as with 
the objections to radiologist testing, can be addressed and overcome; 
e.g., to the extent comments argued that proficiency testing was 
duplicative of current training, education, and experience 
requirements, FDA could consider eliminating some of those 
requirements. However, the agency agrees with the general consensus 
expressed by the comments and concludes that proficiency testing for 
technologists currently cannot provide the basis for a performance 
standard.
    c. Proficiency testing for physicists
    (Comment 38). The agency received 17 comments about this topic. Of 
the 17, 3 were in favor of proficiency testing for physicists, with 1 
additional comment asserting that is would be possible to conduct such 
a test, but only at great cost. Other comments stated that proficiency 
testing for physicists was simply a bad idea. Two comments argued that 
the proposed standards of a written examination and a practical survey 
test were sufficient proficiency measures for physicists. Two comments 
stated that a doctorate in physical science and board certification in 
an appropriate medical physics sub-specialty provided a better 
assurance of professional integrity than written and practical 
examinations. Another comment suggested that it would be more 
appropriate for physicists' accreditation bodies to administer such 
tests because FDA lacked the necessary experience and knowledge in this 
area. One comment expressed concern about the possibility of computer 
errors if the examinations relied on computer programs for test 
administration and scoring. One comment recommended that the idea of a 
qualifying examination for physicists should be further explored, 
especially because the proposed regulations do not adequately address 
the issue of how detailed an annual survey should be.
    One comment asked whether a performance-based standard would help 
physicists working at small institutions to meet the training 
requirements. Although it is possible that proficiency

[[Page 55865]]

testing could alleviate difficulties involving access to training for 
some physicists, FDA notes that it is not possible to determine whether 
such an approach would permit these physicists to qualify until such a 
time as the form and nature of a possible proficiency test is better 
known.
    As with proficiency testing for interpreting physicians and 
radiologic technologists, the comments have persuaded FDA that it would 
be premature to require such testing for physicists as the basis of a 
performance standard. The agency, however, will continue to explore the 
feasibility of such testing for radiologists, technologists, and 
physicists.
5. Mammography Equipment and QC
    The preamble to the proposals (61 FR 14860) suggested possible 
performance-based substitutes for equipment specification and QC 
testing in the proposed rule. One general comment recommended that FDA 
retain the existing QC tests as proposed to ensure adequate mammography 
equipment and QC. The author was of the opinion that one or two 
performance-based criteria would not be adequate to serve as QC 
measures.
    a. Phantom image testing
    FDA suggested that one possibility was that a more sophisticated 
phantom might be developed for use in a single QC test that would 
provide the same information on equipment performance as some or all of 
the separate tests and specifications. A performance-based standard 
predicated on test results using this phantom and falling within 
defined limits might provide the same assurance of image quality as a 
number of the design specifications and, therefore, could replace the 
design specifications in the regulations.
    (Comment 39). One comment stated that it was possible to develop a 
single system test with an alternative phantom. The comment stated that 
one distinct advantage of a single system test would be to replace the 
present daily processor quality control (QC) test with sensitometry 
based on the actual light emission of the radiographic screen and at 
the same time check the performance of the rest of the imaging system. 
The comment stated that the final regulations should allow facilities 
and accreditation bodies to work together to adopt a suitable phantom 
to be used as a daily total system test. The majority of the comments 
received, however, were opposed to using phantom image testing as a 
comprehensive equipment test, even if such testing would permit 
alternative tests to be performed less frequently. There was strong 
support for FDA to implement the mammography performance and design 
requirements described in the proposed rules. Overall, a total of nine 
comments opposed use of the phantom as a daily test that would replace 
other QC tests. It was noted that more frequent use of the phantom 
would increase costs, would not yield an adequate measure of quality, 
would be useful only as a supplement to other QC tests, and would yield 
results that were highly variable. Three comments remarked that phantom 
testing is a good measure of quality but cannot replace all other QC 
tests. Finally, it was noted that the STEP test should be added to the 
phantom image analysis.
    FDA observes that the general consensus of these comments is that 
it is unlikely that testing with a more sophisticated phantom, if one 
is made available through further research, will be an adequate 
substitute for other QC tests.
    b. Repeat rate
    Another measure that was suggested as a possible performance 
standard was the facility's repeat rate. Under the final regulations, a 
repeat rate is to be analyzed every 3 months, and include up to 250 
examinations. In the preamble to the proposal (61 FR 14860), FDA asked 
for comments on the possibility of using the repeat analysis rate in 
some modified form, such as conducting the test continuously, as the 
basis for a performance standard. The agency also noted that such a use 
would have to take into account the possibility that the repeat rate 
could be altered through the acceptance by a mammography facility of 
all images of any quality performed.
    (Comment 40). Responses to this possible alternative were generally 
negative. Three comments contended that the repeat rate could not serve 
as an alternative to existing equipment and QC tests. Specifically, it 
was noted that ongoing repeat analyses could not substitute for QC 
tests. Four comments raised concerns about the possibilities for 
altering or falsifying findings and lack of consistency within and 
between mammography facilities in performing repeat analyses. A related 
comment stated that technologists will not repeat images that should be 
redone if they think the repeated images will affect their job. This 
means poorer images may be submitted to radiologists for 
interpretation.
    FDA recognizes the validity of the concerns raised by these 
comments and has concluded that a performance standard based on repeat 
rate analyses is not likely to enhance quality mammography nationwide.
c. Clinical image review
    FDA identified clinical image review as a possible basis for 
performance-based standards. General comments regarding clinical image 
review for this purpose were largely unfavorable.
    (Comment 41). Nine respondents argued that random selection of 
images for review is unnecessary because the review is conducted by the 
accreditation body. It is better therefore, these comments continued, 
to select previous images of the same patients to document improvements 
in image quality between examinations rather than random selection of 
images. Thirteen comments stated that the supervising radiologist 
ultimately is responsible for assessment of clinical image quality. 
Four comments questioned who would do the clinical image reviews for 
all facilities and suggested that this would require a new government 
agency in a time when government has been directed to downsize. Two 
comments stated that clinical image review is only useful as a learning 
tool in difficult cases and is not useful as a general test of 
proficiency.
    Additional comments were received on the possibility of using 
clinical image review to evaluate the performance of the radiologic 
technologist. Twelve comments were openly opposed to clinical image 
review for assessment of technologists, arguing that it would require a 
large investment of effort and financial resources. One comment said 
that the radiologist, not the technologist, is responsible for the 
quality of images and, consequently, it would be inappropriate to use 
this as a performance assessment for technologists. Another comment 
expressed the point of view that clinical image review was unnecessary 
if technologists remain active in performing mammography and also 
maintain proper licensure.
    The question of who would do the image reviews drew a number of 
comments. One comment said that clinical image review by technologists 
had been tried previously with poor success, although specifics about 
the problems were not mentioned. Nine comments asserted that clinical 
image review to assess technologist performance should be done under 
physician review, rather than by sending images to an outside 
bureaucracy, which would be very costly for facilities. Cost was raised 
as an issue by another respondent who argued that a facility with many 
mammography technologists would have many images out for review, which 
would be both costly and a threat to patient confidentiality. One 
comment suggested that the FDA inspector review

[[Page 55866]]

clinical images at the time of the annual MQSA inspection, rather than 
the facility submitting the images to some central point. Under this 
approach, technologists and radiologists would complete critique forms 
of their images to explain any difficulties or problems in taking or 
reading the films.
    On the more positive side, twelve comments stated that clinical 
image review under the MQSA, combined with additional actions, would 
ensure proper mammography performance sufficient to assess 
technologists' clinical skills. The additional action suggested by 10 
of these comments was yearly attendance at hands-on workshops, while 
another comment suggested periodic recertification examinations, and 
the 12th advocated use of repeat analysis. This last comment also 
suggested that such an evaluation could even substitute for the 
practice volume requirement for technologists in the proposal.
    FDA observes that opinion is divided more evenly on the feasibility 
of using clinical image review as a performance standard for 
technologists than on the feasibility of the other possible bases for 
performance standards mentioned in the proposal. The major problem 
seems to be how to establish an effective system at a reasonable cost. 
Although clinical image review will not substitute for the radiologic 
technologist requirements being finalized in the regulations, FDA will 
continue to evaluate this issue in collaboration with the members of 
NMQAAC and other agencies involved with mammography QC.
6. General Observations
    As discussed above, FDA sought public comment on the possibility of 
taking an alternative approach to assuring the quality of mammography 
nationwide. The alternative approach would be the greater use of 
performance-based standards in place of the primarily design 
specification standards established in the interim regulations and 
proposed for the final regulations. Several possible measures or 
mechanisms that could form the basis for performance-based standards 
were identified and the public was invited to comment on their 
feasibility and also to suggest other options. The agency also asked 
for comments on how it should proceed with regulation development if 
performance-based standards were considered feasible. If such standards 
could be developed relatively quickly, FDA could consider maintaining 
the interim standards and delaying the issuance of final regulations 
until performance-based standards were developed. Conversely, if the 
expected time for the development of performance-based standards was 
lengthy, in the interest of achieving additional improvement in 
mammography more rapidly, the agency might appropriately proceed with 
finalizing the proposed rules (as modified in response to public 
comment) and replace them at a later date with performance-based 
standards after the necessary research for those standards was 
complete.
    (Comment 42). Only four comments addressed these questions directly 
and, as noted above, they urged FDA to proceed with publication of the 
final regulations. FDA also notes, as described above, that the 
comments on the possible mechanisms for performance-based standards 
identified by the agency were predominantly negative. Furthermore, none 
of the comments suggested any other possibilities for performance-based 
standards. This would seem to support the view that performance-based 
standards, if feasible, will require further research. Based on this, 
FDA concluded that it should proceed with the publication of these 
final regulations. If further research and development suggest that 
performance-based standards can replace these regulations, FDA will 
propose amendments to the MQSA rules.

C. Scope Sec. 900.1

    This section briefly summarized the content of the following 
regulatory sections. No comments were received and it was codified 
unchanged.

D. Definitions Sec. 900.2

    This section defines terms used in the regulations whose meaning 
would not be common knowledge or for which there exists more than one 
definition, making it necessary to specify which is to be used for the 
purposes of these regulations. Comments received on the definitions in 
the proposal are discussed first. This is followed by a consideration 
of comments that recommended adding new definitions or made other more 
general comments on the proposed definitions. Discussed third are 
definitions that have been added to, or changed from, those in the 
proposal due to changes in other parts of the regulations.
1. Comments on the Proposed Definitions
    a. General comments on several related definitions
    The following closely related definitions were included in the 
proposal in order to identify which consumer complaints must be 
considered by the facility and the accreditation bodies in the 
complaint process required by the MQSA:
 Adverse event
 Consumer
 Serious adverse event
 Serious complaint
The purpose of these definitions, as explained in the preamble to the 
proposal (61 FR 14863), is to ensure that serious complaints about the 
quality of the MQSA-related mammography services are adequately 
addressed without placing an undue burden on facilities and 
accreditation bodies by requiring extensive consideration for 
relatively minor complaints.
    ``Adverse event'' is defined to mean an undesirable experience 
associated with mammography activities within the scope of 42 U.S.C. 
263b. Examples were included in the definition.
    The definition of a ``consumer'' is intended to make it clear that 
a patient or a representative of the patient (for example, family 
members or referring physicians) can file complaints.
    ``Serious adverse event'' is defined to mean an adverse event that 
could significantly compromise clinical outcomes or for which a 
facility failed to take appropriate corrective action in a timely 
manner. Finally, ``serious complaint'' is defined to mean a report of a 
serious adverse event. Facilities, under Sec. 900.12(h), and 
accreditation bodies, under Sec. 900.4(g), are required to carry out 
specified activities in response to serious complaints.
    (Comment 43). A number of general comments were received on these 
related definitions. One comment stated that using the severity levels 
outlined in current inspection procedures would be more applicable for 
complaint activities than the proposed definitions.
    FDA disagrees with this comment. The severity levels used for the 
MQSA inspection program were developed for use by inspectors. They are 
too technical and not necessarily relevant for consumer complaint 
purposes.
    (Comment 44). One comment recommended removing the terms ``adverse 
event'' and ``serious adverse event'' and the addition of the 
definition of ``complaint'' to mean the report of any undesirable 
experience associated with mammography activities. These experiences 
may include poor image quality, failure to send mammography reports 
within 30 days, or the use of personnel who do not meet regulatory 
requirements. Another comment also suggested adding a definition for 
complaint without specifying what it should be.
    FDA believes that the definition offered by the first comment could 
result in complaints unrelated to the

[[Page 55867]]

MQSA (e.g., billing procedures) and complaints that would not 
ordinarily be considered serious by most patients (e.g., facility 
temperature) being forwarded to the accreditation bodies and FDA when 
they have the greatest chance for resolution at the facility. The final 
regulations require facilities to record all serious complaints. The 
facility will forward unresolved serious complaints to the 
accreditation body and/or FDA for further action. In addition, the 
agency notes that the definitions of ``adverse event'' and ``serious 
adverse event'' give examples of the kind of complaints that are within 
the parameters of the consumer complaint mechanism. All of the examples 
noted in the comment would fall within the scope of consumer complaints 
subject to further accreditation body and FDA review.
    b. Adverse event
    (Comment 45). One comment agreed that the definition of ``adverse 
event'' should include failure to send mammography reports in a timely 
fashion to the referring physician or self-referred patient, but argued 
that 30 days is an unreasonably long time for communication of adverse 
events. FDA notes that the 30-day period referenced in the definition 
is intended as the maximum amount of time that may elapse and that the 
regulations state that the results should be communicated as soon as 
possible.
    This is discussed further in section III.L.3 of this document, 
where FDA's responses to comments received on Secs. 900.12(c)(2) 
Communication of mammography results to the patient, and 900.12(c)(3) 
Communication of mammography results to health care providers, are 
given.
    (Comment 46). Several comments requested greater clarity or 
additional explanation for the term ``poor image quality'' (used in the 
definition of adverse event), and FDA's criteria to determine when 
image quality is poor. The comment observed that the definition of poor 
image quality is likely to be very subjective.
    FDA agrees that a single definition for poor image quality would be 
subjective and, therefore, has not included such a definition in order 
to give facilities and accreditation bodies the flexibility to evaluate 
such performance in a particular situation on a case-by-case basis. 
However, criteria to be considered by accreditation bodies in 
evaluating acceptable image quality are specified in Sec. 900.4(c)(2). 
Consumers who decide to complain about poor image quality would 
generally have assistance from health professionals (for example, 
referring or consulting physicians, or accreditation body) in making 
this determination. In situations in which FDA has reason to believe 
image quality at a particular facility is poor, FDA may consult with 
accreditation bodies for additional mammography review in order to 
determine whether corrective or enforcement actions are appropriate.
    c. Serious adverse event
    The regulation defines ``serious adverse event'' as ``an adverse 
event that may significantly compromise clinical outcomes, or an 
adverse event for which a facility fails to take appropriate corrective 
action in a timely manner.''
    (Comment 47). Four comments recommended that the definition of 
``serious adverse event'' should be revised. They stated that failure 
to take action on a nonserious event should not turn the event into a 
serious complaint. The comments recommended that ``serious complaint'' 
should be written to preclude common and potentially unavoidable 
complaints about mammography (e.g., compression hurts, room too cold).
    FDA disagrees that the definition should be revised. Failure to 
take action on certain nonserious events may indeed result in a serious 
adverse event. For example, it is generally accepted that most 
compression complaints are considered to be minor. However, there may 
be instances in which compression is unusually severe and, therefore, 
the complaint would be considered serious. FDA believes the definition 
should remain flexible to allow for this type of situation.
    (Comment 48). One comment suggested changing ``may significantly 
compromise clinical outcomes'' to ``has significantly compromised 
clinical outcomes.''
    FDA disagrees. A primary goal of the consumer complaint mechanism 
is to improve mammography services by providing facilities with data 
and information they might not otherwise receive or analyze. It is 
preferable to correct a potentially serious situation before harm 
occurs, rather than after the harm has affected the patient.
    d. Serious complaint
    (Comment 49). A ``serious complaint'' is defined as ``a report of a 
serious adverse event.'' Two comments suggested that descriptions of 
the type of serious complaints to be reported to the accreditation body 
should be specified.
    FDA agrees that additional descriptions will be helpful and intends 
to make such information available through guidance. The agency 
believes that making this information available in guidance, rather 
than in regulations, will give facilities, accreditation bodies, and 
FDA the flexibility to determine on a case-by-case basis whether or not 
an event should be classified as serious.
    e. Contact hour
    ``Contact hour'' was defined in the proposal as an hour of training 
received through direct instruction.
    (Comment 50). One comment recommended that it be defined as 50 
minutes.
    FDA is aware that in academic institutions an hour of didactic 
training is frequently only 50 minutes long. However, in clinical and 
continuing education situations, an hour of instruction is usually a 
full 60 minutes. Reducing the figure from 60 to 50 minutes would reduce 
the training requirements 16 percent. Because those training 
requirements were proposed at what are believed to be the minimum 
adequate levels, the agency did not change the definition.
    f. Direct instruction
    Direct instruction requires instructor-student interaction, either 
face-to-face or through examination.
    (Comment 51). One comment stated that the definition is too vague, 
especially when compared to mammography equipment evaluation.
    FDA disagrees. The agency believes the definition is sufficiently 
specific to give a clear idea of what is required, while also 
preserving the flexibility to accept possible new approaches to 
instruction.
    g. Direct supervision
    The definition of direct supervision was designed to permit 
``trainees'' to lawfully obtain the experience in interpreting or 
producing mammograms or surveying mammography units that they needed to 
become qualified or requalified. At the same time, by having the 
trainee's work checked and, if necessary, corrected before any clinical 
care might be jeopardized, the patient's right to adequate quality 
mammography is protected.
    (Comment 52). One comment supported this definition. A second 
comment asked if direct supervision was needed for ``nonqualified'' 
people doing the QC tests.
    In accordance with 42 U.S.C. 263b(f)(1), personnel qualifications 
were established only for interpreting physicians, radiologic 
technologists, and medical physicists. As a result, tests performed by 
medical physicist ``trainees'' would have to be done under this 
definition of direct supervision, although tests performed by QC 
technologist ``trainees'' would not. However, the agency notes that 
Sec. 900.12(d)(1)(iv) makes the QC technologist responsible for 
ensuring the quality of performance of those

[[Page 55868]]

doing QC tests. The definition of QC technologist in Sec. 900.2(pp) 
requires the QC technologists to meet the requirements for a radiologic 
technologist, including training in quality assurance/QC. Taken 
together, these requirements provide for a level of supervision similar 
to that provided under this definition.
    h. Facility
    The definition of ``facility'' is provided by the law itself in 42 
U.S.C. 263b(a)(3). It includes a variety of types of locations where 
mammograms are produced, processed, or interpreted.
    (Comment 53). Three comments either inquired if processing and 
interpreting facilities would have to be certified and inspected or 
asked that these facilities be excluded from the requirements. The law 
defines locations where mammograms are processed or interpreted, and 
where mammograms are produced, as facilities (42 U.S.C. 263b(a)(3)). 
The agency's approach under the interim regulations, which is expected 
to continue under the final regulations, has been a systems approach. 
The facility producing the mammograms receives the certificate and is 
responsible for ensuring that the facilities at which their mammograms 
are processed and interpreted, if separate, meet the applicable quality 
standards. This is consistent with the statutory provision that 
requires the facility performing the mammography to be responsible for 
meeting quality standards (42 U.S.C. 263b(a)(3)(B)). FDA has not set up 
a separate certification and inspection system for facilities that 
process or interpret only. However, because a certification system for 
``partial'' providers may have some advantages for such facilities, the 
agency may consider such an approach in the future.
    (Comment 54). Two comments requested that the definition be 
expanded to address situations involving multiple locations under the 
same certificate or temporary locations where a unit (stationary, 
portable, or mobile) is used more than a minimum number of days.
    FDA's experience under the interim regulations shows there is wide 
variety in the locations at which mammography is performed and in the 
corporate and business relationships among these locations. Presently, 
such situations are handled on a case-by-case basis in consultation 
with the facilities and accreditation bodies involved. The agency 
believes that it is essential that this flexibility be maintained and 
that it would be unduly restrictive to prescribe permissible locality 
arrangements in regulation.
    i. First allowable time
    The proposal defined ``first allowable time'' as the earliest time 
a physician is eligible to take the diagnostic radiology boards of an 
eligible certifying body. Because the ``first allowable time'' a 
resident physician becomes eligible to take the boards may vary with 
the certifying body, the definition cannot be more specific. If a 
resident physician wishes to use the exemption from the initial 
experience requirement described in Sec. 900.12(a)(1)(iii)(B), it is 
the physician's responsibility to ascertain the requirements of the 
body by which he or she wishes to become certified and to seek that 
certification as soon as he or she becomes eligible to do so.
    (Comment 55). Three comments stated that this definition was 
unclear and were unsure how or why this related to resident physicians 
who would be interpreting 240 mammograms during a 6-month period. 
NMQAAC also stated that the concept of ``first allowable time'' 
required further explanation.
    This term is used in Sec. 900.12(a)(1)(iii)(B). That provision is 
an exemption that allows resident physicians to interpret the 240 
mammograms required for initial experience in any 6-month period during 
the last 2 years of their residency program (rather than during the 
last 6 months immediately prior to the date that the physician 
qualifies as an interpreting physician as required under 
Sec. 900.12(a)(1)(D)). This exemption is available as long as these 
physicians become board certified the first time they are eligible. 
This provision allows residency programs to be flexible in scheduling 
training for their resident physicians and eliminates the need to put 
all senior resident physicians on their mammography rotation during the 
last 6 months of their program.
    (Comment 56). Two comments stated that because the ``first 
allowable time'' may vary with the certifying body, a more uniform 
standard would be preferable.
    FDA believes that the term ``first allowable time'' must be defined 
as proposed in order to allow flexibility, because certifying bodies 
differ in the scheduling of their examinations. Anything more 
proscriptive could penalize future resident physicians if the 
certifying body wished to change its examination schedule.
    j. Lead interpreting physician
    This term was included in the proposal to identify the interpreting 
physician who has the general responsibility for ensuring that the 
facility meets the quality assurance requirements.
    (Comment 57). One comment stated that the definition was not needed 
because this person is easily identified, while a second comment wanted 
the term changed to supervising interpreting physician.
    FDA agrees that in most facilities the person with this 
responsibility can be easily identified, but also believes there is an 
advantage in having a term that can be used to designate and reference 
this individual, both for the benefit of the employee and patients of 
the facilities and for the accreditation bodies and the government 
regulators. The possibility of using ``supervising'' was discussed with 
NMQAAC but was rejected out of concern about possible confusion between 
this individual and administrative supervisors who may have different 
responsibilities.
    k. Mammographic modality
    ``Modality,'' as proposed, means a technology, within the scope of 
42 U.S.C. 263b, for radiography of the breast. Screen-film and 
xeromammography were given as examples of a modality. In fact, at 
present, they are the only examples in general use.
    (Comment 58). Two comments stated that the term modality has other 
uses in medicine and that the definition could be confusing to 
facilities. Twelve other comments also found the term unclear.
    FDA notes that NMQAAC spent some time discussing other possible 
terms that could be used before concluding that this was the most 
appropriate. The agency is aware that the term modality is used in 
different ways in different areas, which is why a definition of its 
meaning with respect to the MQSA is needed. In an effort to distinguish 
it further from the other meanings of modality, FDA has changed the 
name of the term being defined from ``modality'' to ``mammographic 
modality.'' The definition now appears in the final regulations at 
Sec. 900.2(z).
    (Comment 59). Two comments recommended that the term ``modality'' 
be replaced with ``specialized techniques in mammography.''
    FDA did not accept this suggestion because both ``techniques'' and 
``specialized techniques'' already have a variety of meanings in 
radiology and the agency concluded that the recommended change would 
increase rather than reduce confusion.
    (Comment 60). Nine comments suggested that the definition be 
broadened to include other technology. Stereotactic, ultrasound, 
digital, nuclear medicine, Magnetic Resonance Imaging (MRI), and CT 
were all suggested for addition.

[[Page 55869]]

    FDA does not believe that the definition should be broadened. The 
definition is intended to clarify training requirements for personnel 
providing mammography services. These individuals are required to have 
training in each mammographic modality with which they work. Because 
ultrasound, nuclear medicine, and MRI fall outside the statutory 
definition of mammography as radiography of the breast, the agency 
cannot include training related to those technologies as part of the 
regulatory requirements. Digital, CT, and stereotactic do fall under 
the authority granted by 42 U.S.C. 263b but have been temporarily 
exempted from the regulatory requirements. When and if training and 
other requirements related to these technologies are issued, the 
proposed definition will not delay such requirements from taking effect 
for those modalities.
    (Comment 61). One comment recommended that xeromammography be 
excluded from the definition because it produced less than optimal 
mammograms at a higher dose.
    FDA agrees that there have been problems with the use of 
xeromammography and notes that these problems have led to its near 
disappearance. However, the effect of removing xeromammography from the 
definition would be to exempt those who use the technology from having 
to obtain training. FDA expects such a change would increase, not 
decrease, the problems with the modality.
    l. Mammography
    This definition incorporates the definition of mammography as 
``radiography of the breast'' provided by 42 U.S.C. 263b(a)(6), but 
temporarily excludes from the quality standards radiography of the 
breast performed in interventional mammography or with an 
investigational mammography device during a scientific study conducted 
in accordance with FDA's investigational device exemption regulations.
    (Comment 62). One comment suggested that ``for the purposes of 
these regulations'' should be inserted in this definition.
    FDA believes that it is well understood that all definitions that 
appear with any regulation are for the purposes of those regulations.
    (Comment 63). Another comment suggested expanding the wording of 
the definition to specifically mention X-ray radiation and several 
types of image receptors. FDA notes that the term radiography implies 
the use of X-rays.
    The agency further notes that if the changes were made, and a new, 
yet unimagined type of image receptor was approved following 
investigational device studies, the definition would have to be amended 
before the new device could be put into general use. To avoid such a 
delay in the use of an advance in image receptor technology, the agency 
has retained the proposed general definition.
    m. Exclusion of interventional mammography
    In the proposal (61 FR 14862), FDA temporarily excluded 
interventional mammography (radiography performed during invasive 
interventions for localizations or biopsy procedures) from the 
definition of mammography. This had the effect of exempting such 
mammography from the requirements of the regulations. A similar 
exemption has been in effect under the September 30, 1994, amendments 
to the interim regulations (59 FR 49808-49813). The basis for the 
exclusion, as explained in the preamble to the proposal (61 FR 14862), 
was the agency's belief that science had not advanced to the point 
where effective national quality standards could be developed for these 
devices.
    (Comment 64). Over 90 comments supported the exclusion of 
interventional mammography. Many of these agreed that there currently 
is no consensus with respect to appropriate standards for stereotactic 
units, and until regulations based on scientific data can be developed, 
it is inappropriate to include interventional procedures within the 
scope of the regulations. In addition, the comments stated that 
surgeons have extensive experience in dealing with breast disease and 
breast biopsy and they are best suited to manage the patient. These 
comments noted that many surgeons have had extensive experience 
performing stereotactically guided breast biopsies and have achieved 
good results with this procedure. Others wrote that in this procedure, 
the surgeon knows that the lesion is present and is merely using 
stereotactic images to guide the needle to the proper position for 
biopsy. Other comments stated that while radiologists have only one 
method to biopsy the breast, surgeons have several options and can 
offer the patient the best biopsy option for her clinical status. Some 
comments stated that surgeons have a long history of providing followup 
care for patients and for many years have used radiographic equipment 
in the operating room and are familiar with its use. Several comments 
said that surgeons have used mammography for many years in the 
diagnosis and treatment planning for breast cancer patients. Still 
others said that these biopsy procedures will evolve into therapeutic 
procedures that are best handled by the surgeon and that surgeons are 
best equipped to handle any followup or complications associated with 
these biopsy procedures.
    NMQAAC and over 100 comments opposed the exclusion of 
interventional mammography. Many of these asserted that it is 
counterproductive to set quality standards for mammographic diagnosis 
while having none for mammographically guided invasive breast 
procedures and that only interpreting physicians have the expertise and 
experience necessary to perform this procedure. Authors of other 
comments wrote that interpreting physicians have experience dealing 
with the quality assurance and QC issues necessary to maintain 
stereotactic biopsy equipment and that the failure to regulate this 
procedure places the public at risk. Some said that the lack of 
adequate mammographic training could lead to the lesion in question 
being missed during tissue sampling and that the abilities and training 
required to localize a small subtle suspicious area are the same as 
those for interpreting a mammogram. Other comments stated that only 
interpreting physicians will be able to interpret the original 
mammograms to determine if a needle biopsy is appropriate.
    FDA agrees with the comments stating that interventional 
mammography can be of great use in the evaluation of breast disease, 
but only if optimally performed. Until recently, the science had not 
advanced to the point where effective national quality standards could 
be developed for these procedures. Since the publication of the 
proposed regulations on April 3, 1996, significant progress has 
occurred in the professional community and FDA now believes that there 
is enough information to begin the development of interventional 
mammographic regulations. However, that development requires a 
comprehensive and careful approach that addresses all the factors 
involved in such procedures. The agency has already begun the 
development process by bringing this issue before NMQAAC during its 
October 1996 meeting and is continuing to gather information and data. 
Although the agency has concluded that the final regulations should 
exclude coverage of interventional mammography, FDA expects to propose 
regulations covering all aspects of interventional mammography in the 
near future.
    n. Exclusion of investigational devices
    In the proposal, FDA also excluded from the definition of 
mammography,

[[Page 55870]]

and thus from the regulatory requirements, investigational mammography 
devices that were being evaluated in accordance with FDA's 
investigational device exemption regulations in 21 CFR part 812. This 
provision extended the exclusion for investigational devices previously 
established under the September 30, 1994, amendments to the interim 
regulations. The agency believes that it is obvious that it would be 
premature to establish standards for devices still in the experimental 
stage. FDA also believes that the precautions built into the agency's 
general investigational device exemption regulations provide adequate 
protection for the public health during the use of these devices. 
However, the agency made clear in the preamble to the proposal (61 FR 
14862) that any conventional mammography device used during the 
scientific study to provide baseline data for evaluating the safety and 
efficacy of the investigational device was not within the scope of the 
exclusion and would have to meet the MQSA requirements.
    (Comment 65). Two comments stated that the wording of this section 
would make MRI for mammography investigations or use of full field 
digital mammography illegal, unless they are performed by a radiologist 
specializing in mammography.
    MRI is not radiography of the breast and, therefore, does not come 
under the definition of mammography. Similarly, investigational 
studies, such as those involving full field digital mammography, are 
specifically excluded under the definition of mammography in 
Sec. 900.2(z)(2) of the final regulations. FDA concludes, therefore, 
that the regulations will not prevent such research from occurring. 
However, any conventional mammography performed as part of a study is 
not excluded and does have to meet all the requirements of the final 
regulations. FDA has modified the definition to clarify this issue.
    o. Mammography medical outcomes audit
    ``Mammography medical outcomes audit'' means a systematic 
collection of mammography results and the comparison of those results 
with outcomes data.
    (Comment 66). One comment stated that the term ``medical audit'' 
was self-explanatory and did not need a definition.
    FDA disagrees. There are many different working definitions of this 
term being used in the professional community. FDA's definition of what 
minimally constitutes a mammography medical outcomes audit is for the 
purposes of the MQSA requirements and may be different from recommended 
guidelines and definitions of other organizations.
    p. Mammography unit or units
    The definition for ``mammography unit or units'' is an assemblage 
of components for the production of X-rays for use during mammography. 
Several components were listed.
    (Comment 67). Two comments suggested that compression device, 
breast support, and components associated with the image receptor and 
grid be added to the list.
    These suggestions would not fit the general criterion of a 
component for the production of X-rays and the agency is not adding 
them to the list.
    q. Mean optical density
    ``Mean optical density'' was defined as the average of the optical 
densities measured for phantom thicknesses of 2 to 6 centimeters (cm) 
using kilovolt peak (kVp) values clinically appropriate for the 
thicknesses.
    (Comment 68). Three comments were received on this definition. One 
suggested that the thickness range should be changed to 3 to 7 cm. A 
second also supported a 3 to 7 cm range, but stated it would be prudent 
to check at 2 and 8 cm as well. The third comment stated that, because 
the thicknesses chosen could influence the result, the definition 
should specify the thicknesses to be used. The comment further 
suggested that 2, 4, and 6 cm should be used.
    This definition is used in connection with a QC test of Automatic 
Exposure Control performance. The test procedures recommended by the 
ACR manuals and incorporated by reference into the interim regulations 
requires the use of 2, 4, and 6 cm thicknesses. The agency agrees with 
the third comment that it would be of value to add the exact 
thicknesses to the definition and has done so. FDA does not believe 
there is justification for changing the range of thicknesses used in 
this standard test, as suggested by the other two comments.
    r. Medical physicist
    ``Medical physicist'' is defined as a person trained in evaluating 
the performance of mammography equipment and quality assurance programs 
and who meets the requirements of Sec. 900.12(a)(3).
    (Comment 69). One comment stated that the MQSA does not provide 
statutory authority to FDA to define the profession of medical 
physicist.
    It is not FDA's intention to define the profession of medical 
physicist in general and the agency also agrees that it lacks the 
authority to do so. However, the MQSA requires that the agency 
establish qualifications for those medical physicists providing 
mammography services to mammography facilities (42 U.S.C. 263b(f)(1)(E) 
and (F)). This provides both the authority and responsibility to define 
``medical physicist'' for the purpose of these regulations. Again, this 
definition applies only to medical physicists who wish to provide 
services to mammography facilities under the MQSA and not to the 
profession as a whole.
    s. Multi-reading
    ``Double reading,'' defined as two or more interpreting physicians 
interpreting the same clinical image, was included in the proposal to 
describe one of the options that interpreting physicians can use to 
meet the experience requirements.
    (Comment 70). Several comments, including a consensus of NMQAAC, 
requested further clarification of this term. Confusion apparently has 
arisen due to the fact that ``double reading'' commonly is used to 
describe the situation where a mammogram is read by two interpreting 
physicians in an attempt to improve the accuracy of the interpretation. 
Two comments, including a consensus comment from NMQAAC, suggested that 
another term be used to describe multiple interpretation as it applies 
to the final regulations.
     In response to these comments, FDA has substituted the term 
``multi-read'' to describe interpretation of mammograms by two or more 
physicians. Multi-reading can be used by physicians to meet continuing 
experience requirements. Multi-reading can also be used by physicians 
to meet initial and/or requalification requirements if it is done under 
direct supervision.
    (Comment 71). Some of the comments incorrectly assumed that FDA was 
forcing facilities to have all their mammograms read by two 
interpreting physicians.
    While facilities are free to perform this type of ``multi-reading'' 
as a means to improve accuracy, FDA does not require that any mammogram 
be read by more than one interpreting physician.
    (Comment 72). One comment suggested adding the words ``that has not 
been marked as to possible pathology'' at the end of the definition of 
``double read'' (now changed to multi-read).
    FDA disagrees and believes that an interpreting physician benefits 
from reviewing mammograms, even those that have been marked by another 
physician. Requiring the removal of such marks would be overly 
burdensome and might even be

[[Page 55871]]

detrimental to the patient if the original marks were not put back on 
the images.
    (Comment 73). One comment requested clarification as to whether 
physicians must independently interpret the same clinical image, or is 
it within the intent of the definition to include two or more 
physicians in consultation interpreting the image together.
    FDA intends the concept of ``multi-reading'' to include both 
independent and consultative reading. If the multi-reading is done 
under direct supervision, there must be a consultative component to the 
supervision.
    t. Patient
    In the proposal, FDA used ``examinee'' to refer to any individual 
undergoing a mammography examination. This was a change from the term 
``patient,'' which was used in the interim regulations. As explained in 
the preamble to the proposal (61 FR 14862), the change was made in 
recognition of the fact that most individuals who undergo mammography 
are not ill and do not have a condition requiring medical care.
    (Comment 74). Eighteen comments stated that it was not necessary to 
replace ``patient'' with ``examinee,'' because patient is a term used 
universally. One comment objected to the proposed use of ``examinee'' 
and preferred ``patient'' because ``patient'' conveys the ethical 
protections of a doctor-patient relationship, confers malpractice 
protection, and ensures that third party payers recognize the 
examination as required care. One comment agreed with the definition of 
examinee and the inclusion of self-referred persons.
    NMQAAC discussed these comments and there was general consensus to 
recommend that FDA use the term ``patient,'' provided the definition 
would include people who did not have health care providers and people 
without medical symptoms. Finally it should be noted that the MQSA uses 
the term patient. In light of these comments, FDA has decided to return 
to the use of ``patient,'' which is defined in the final regulations as 
anyone undergoing a mammographic procedure.
    u. Phantom
    ``Phantom'' is defined as a test object used to simulate 
radiographic characteristics of compressed breast tissue and containing 
components that radiographically model aspects of breast tissue and 
disease.
    (Comment 75). One comment on this definition requested that FDA 
specify the phantom contents and measurements. A second comment urged 
FDA not to change the current phantom unless the new phantom decreased 
the frequency of other testing.
    FDA believes that the accreditation bodies should establish the 
phantom specifications and related performance criteria, rather than 
the agency establishing them through regulation. However, as part of 
its responsibilities for accreditation body approval and oversight, FDA 
will examine each body's phantom specifications and performance 
requirements to ensure that they are substantially the same among 
different accreditation bodies.
    FDA believes that the second comment was in response to the 
suggestion that a more sophisticated phantom might facilitate the 
establishment of performance outcomes standards based on the new 
phantom's use that would take the place of several of the existing 
tests. This issue was discussed previously with other comments on that 
subject under section III.B of this document, where the agency 
concluded that performance standards based on a new phantom were not 
practical at this time.
    v. Physical science
    ``Physical science'' means physics, chemistry, radiation science 
(including medical physics and health physics), and engineering.
    (Comment 76). One comment received on this definition stated that 
the engineering part of this definition should be limited to electrical 
and nuclear engineering only, while a second comment opposed the 
inclusion of engineering and chemistry at all.
    FDA notes that this term is used to establish the qualifications to 
be met by medical physicists, which include a degree in the physical 
sciences on an appropriate level. The purpose of that part of the 
requirements is to ensure that the individual has a general familiarity 
with the scientific concepts, calculations, and techniques that provide 
a basis for understanding and completing more specialized work in 
medical physics, not that he or she has already achieved the training 
in medical physics. The agency further notes that this general 
requirement is reinforced with a more specific requirement for training 
in physics. Because meeting these two requirements provides an adequate 
foundation for meeting the more specialized medical physics 
requirements, the agency does not believe the definition needs to be 
narrowed by eliminating the fields suggested in the comments.
    w. Positive mammogram
    ``Positive mammogram'' means a mammogram that has an overall 
assessment of findings that are either ``suspicious'' or ``highly 
suggestive of malignancy.''
    (Comment 77). One comment stated that the term positive mammogram 
was self-explanatory and did not need a definition. FDA disagrees. 
There are many different working definitions of this term being used in 
the professional community. Because the final regulations require all 
positive mammograms to be entered into the facility's medical audit 
system, it is necessary to retain a definition of ``positive 
mammogram'' in order to clarify the scope of the audit.
    x. QC technologist
    This term was defined to mean the individual who is responsible for 
the segments of the quality assurance program that are not the 
responsibility of the lead interpreting physician or the medical 
physicist. In general, this responsibility consists of the routine QC 
testing and some data analysis and corrective actions related to the 
results of that testing.
    (Comment 78). One comment stated that it is not necessary to 
identify or define this position because the person with this 
responsibility is easily identified.
    FDA does not agree with this comment for the same reason it 
disagreed with the similar comment about the definition of lead 
interpreting physician. In addition, the title of QC technologist is 
already widely used in mammography facilities.
    This definition was changed, however, as a result of discussions at 
the January 1997 NMQAAC meeting. It is often possible for a single 
individual to perform the duties of a QC technologist for an entire 
radiology facility. That individual ordinarily is a technologist, but 
may not meet the qualifications to do mammography. At early meetings, 
NMQAAC had agreed that this person should be a qualified technologist, 
but did not necessarily have to be qualified to perform mammography. 
This would avoid the possibility that the mammography department of a 
radiology facility might have to have its own QC technologist, thus 
forcing the facility to assign two persons to meet the responsibilities 
previously handled by one. NMQAAC reconsidered its position at the 
January 1997 meeting, however, and concluded that the advantages of 
having the QC technologist in the mammography department be qualified 
to do mammography outweighed the possible extra costs. FDA accepted 
NMQAAC's advice on this matter and changed the wording in the 
definition to require the QC technologist to meet all the 
qualifications in Sec. 900.12(a)(2) for

[[Page 55872]]

radiologic technologists doing mammography.
    (Comment 79). Three comments disagreed with the proposed definition 
because it barred qualified biomedical engineers, manufacturer's 
representatives, and other individuals the authors believed were 
qualified from serving as QC technologists. Although NMQAAC has changed 
its position from time to time on whether the QC technologist must be 
qualified to do mammography, it has never wavered from its advice that 
the individual in this position should be a radiologic technologist. 
FDA concurs with that view. However, as discussed below in connection 
with the quality assurance requirements under Sec. 900.12(d)(1)(iv), 
the final regulations permit nontechnologists to perform certain QC 
tasks as long as the QC technologist ensures that the performance is 
adequate.
    y. Traceable to a national standard
    Traceability refers to the ability to show that an instrument has 
been calibrated by a process that eventually led back to a standard 
established by the National Institute of Standards and Technology 
(NIST).
    (Comment 80). A number of comments requested further clarification 
of traceability. A few comments requested that the requirement for 
annual calibration be changed to every 3 years.
    In response to these comments and after discussion with calibration 
experts, FDA has revised the definition of traceability. The term 
itself has been changed to ``traceable to a national standard'' to more 
clearly reflect what is needed. Other changes have clarified that the 
ultimate source of the calibration may be either NIST or a calibration 
facility that participates in a proficiency program with NIST at least 
once every 2 years during which the calibration facility achieves 
agreement within + 3 percent of the NIST standard at mammography energy 
levels.
2. New Definitions Suggested by the Comments
    a. Category I
    (Comment 81). Several comments suggested that the meaning of the 
term ``Category I,'' as used in the regulations, was unclear.
    In response, FDA has defined Category I, at Sec. 900.2(g), to mean 
medical educational activities that have been designated as Category I 
by the Accreditation Council for Continuing Medical Education, the 
American Osteopathic Association, a State medical society, or an 
equivalent organization.
    b.  Contact mammography
    (Comment 82). One comment recommended that this term from the final 
regulations should be defined. However, in the revisions of the 
regulations following the public comments, this term has been 
eliminated, so a definition is no longer needed.
    c. Continuing education unit
    (Comment 83). One comment warned that it would be difficult to 
interpret the personnel training requirements if the term continuing 
education unit was not defined.
    FDA agrees with this comment and has added a new Sec. 900.2(l), 
which states that continuing education unit or continuing education 
credit means 1 contact hour.
    d. Diagnostic and screening mammography
    (Comment 84). Over 30 comments stated that diagnostic and screening 
mammography should be defined and asserted that vacillation over these 
definitions only confuses the public and those who are to measure 
outcomes.
    As explained in the proposed rule (61 FR 14862), FDA is eliminating 
these terms from the definitions section because differences of opinion 
within the professional community regarding the distinction between 
these two types of mammography procedures remain unresolved. These 
terms can have different meanings depending upon their context. For 
example, HCFA has defined screening and diagnostic mammography for 
claim processing purposes. AHCPR has defined these terms in their 
guidelines for medical audits. On the other hand, some facilities do 
not distinguish between screening and diagnostic mammography. 
Facilities also differ on categorizing certain circumstances as 
screening or diagnostic, as in the example of a healthy, asymptomatic 
woman with breast implants who has diagnostic views performed during 
``routine screening.'' The terms screening and diagnostic mammography, 
along with other terms and definitions associated with the medical 
audit, are in the process of obtaining consensus within the scientific 
community. At present, FDA recommends that each facility choose and 
consistently utilize HCFA, AHCPR, or other definitions in the medical 
literature for medical audit purposes.
    e. Established operating level
    (Comment 85). One comment noted that this term was used in 
connection with a number of QC tests and suggested that it be defined 
as ``the single point for a particular quality assurance parameter set 
by the lead interpreting physician.''
    FDA agrees that a definition of established operating level is 
needed and has added, at Sec. 900.2(p), that ``established operating 
level means the value of a particular quality assurance parameter that 
has been established as acceptable by the facility's quality assurance 
program.'' This definition indicates that the level should not be 
merely set but also should be determined to be acceptable. The 
responsibility for making that determination will belong primarily to 
the lead interpreting physician, as the comment suggested. However, the 
definition being issued refers to acceptance as part of the entire 
quality assurance program because additional facility and FDA personnel 
also may be consulted when the level is established.
    f. Image receptor
    (Comment 86). Two comments suggested that a definition of image 
receptor be included in the final regulations. FDA notes that there is 
a general understanding within the radiology and general medical 
community of what this means and if a specific definition is needed, 
one is already available in 21 CFR 1020.30(b). The agency does not 
believe that it needs to be repeated here.
    g. Image receptor support device
    (Comment 87). One comment suggested that a definition of image 
receptor support device as that part of the mammography X-ray unit that 
is designed by the manufacturer to hold the cassette be added to 
clarify Sec. 900.12(b)(5).
    FDA agrees that this is a useful suggestion. However, as a result 
of other revisions that have been made to the proposal, the term 
``image receptor support device'' is no longer used in the regulations 
and, therefore, a definition is no longer needed.
    h. Laterality
    (Comment 88). Several comments found the meaning of the term 
``laterality,'' as used in the regulations, to be unclear.
    In response to these comments, FDA has defined laterality, at 
Sec. 900.2(w), to mean the designation of either the right or left 
breast.
    i. Mammography equipment
    (Comment 89). One comment suggested that a definition of 
``mammography equipment'' should be added and further suggested that 
the definition include all physical components of a mammography 
facility needed to produce an interpretable film. The author believed 
that this would more clearly define the components that the physicist 
would need to include in the required ``survey'' of ``mammography 
equipment'' for which

[[Page 55873]]

he or she has been assigned responsibility under 
Sec. 900.12(d)(1)(iii).
    FDA considered the possibility of adding this definition, but notes 
that Sec. 900.12(e)(9) already establishes the evaluations that, at a 
minimum, are to be included in the survey. Because of this, the agency 
decided that an additional definition was not needed.
    j. Mobile unit
    (Comment 90). Three comments suggested that mobile units should be 
defined in such a way as to clarify when mammography units used under a 
variety of different circumstances are to be included in this category.
    FDA notes that the term mobile unit is relevant to compliance with 
these regulations only in determining when the additional testing 
required by Sec. 900.12(e)(7) needs to be performed. Under 
Sec. 900.12(e)(7), a mobile unit is one that is used to produce 
mammograms at more than one location. The agency believes 
Sec. 900.12(e)(7) makes it sufficiently clear when the additional 
testing is needed.
    k. Quality assurance, quality assurance program, and QC
    (Comment 91). Two comments recommended that these terms be defined. 
FDA notes that one or more of these terms have been defined in 21 CFR 
1000.55, in the ACR Quality Assurance manuals, or by various other 
authorities. While the wording of these definitions may vary, the basic 
concepts are the same and are widely understood. The agency does not 
believe that they need to be defined again.
    l. Technique chart
    (Comment 92). One comment among those that suggested that a 
technique chart should be part of the quality assurance manual also 
noted that this would require defining technique chart. The comment 
also made some suggestions for the definition.
    FDA notes that, as will be discussed with other comments related to 
quality assurance records required under Sec. 900.12(d)(2), a technique 
chart is not being required to be included in the facility's quality 
assurance manual. Because the term is not used in the regulations, a 
definition is not needed.
    m.  Other comments on the proposed definitions
    (Comment 93). Thirteen identical comments wanted the quality 
assurance definitions changed, stating that, ``it is objectionable to 
have the FDA creating definitions of medical terms not agreed on by 
physicians.''
    Quality assurance is not defined in the regulations and, as 
discussed above, the agency does not believe such a definition is 
needed. From other information in the letters containing the comments, 
it appears that they are actually referring to specific definitions 
discussed under the heading of ``Quality Assurance'' in the preamble to 
the proposal. There were four such definitions: ``lead interpreting 
physician,'' ``QC technologist,'' ``time cycle,'' and ``traceability.''
    FDA agrees that, to the extent possible, the agency should adopt 
definitions for medical terms that have widespread agreement among 
physicians. In fact, QC technologist, as discussed above, is already a 
title widely used in facilities and in the ACR manuals. It appears that 
medical facilities have already reached consensus on its use as an 
administrative title, although there may be differences on the 
necessary qualifications of such individuals.
    The agency does not agree that the other three terms are medical 
terms whose definitions require agreement among physicians. ``Time 
cycle'' and ``traceability'' are technical terms related to the film 
development time and the calibration of radiation measuring 
instruments. These are not terms that physicians use regularly or about 
which they are likely to discuss and reach consensus. The remaining 
term, lead interpreting physician, is an administrative term, not a 
medical one. As discussed previously, this term has been defined as the 
designation of an individual physician at each facility who has certain 
responsibilities under these regulations; that identification will make 
it easier for facilities, accreditation bodies, and government 
regulators to ensure and monitor compliance with the MQSA standards.
3. New or Changed Definitions Made Necessary by Changes in the 
Regulations
    a. Air kerma and kerma
    The Omnibus Trade and Competitiveness Act of 1988 amended the 
Metric Conversion Act of 1975 to require each Federal agency to use the 
International Systems of Units (SI) in its activities. The SI is also 
known as the metric system although it makes use of only some of the 
metric quantities and units. In accordance with this requirement, a 
memorandum dated March 19, 1990, from FDA's Associate Commissioners of 
Regulatory Affairs and Public Affairs, established the FDA policy for 
the use of SI metric measurement. Since 1990, FDA has been undergoing a 
transition to SI quantities and units in its regulatory activities. To 
this end, air kerma, which is an SI quantity, has been introduced as a 
replacement for the quantity of exposure previously referenced in 
Sec. 900.12(e)(5)(v). Definitions of ``air kerma'' and ``kerma'' were 
also added as Secs. 900.2(d) and 900.2(v), respectively, in the final 
regulations.
    b. Calendar quarter
    To give facilities more flexibility in maintaining their records on 
personnel qualifications, changes were made in several provisions of 
Sec. 900.12(a). These changes allow the facility to use a variety of 
methods to calculate the time periods necessary to establish compliance 
with personnel requirements. In calculating these time periods, the 
facility may designate any one of the following as the endpoint for the 
period of time used to determine if their staff met the continuing 
education and experience requirements: (1) The date of the inspection; 
(2) the last day of the last calendar quarter before the inspection; or 
(3) any date in between those two. To avoid any misunderstandings, FDA 
added a definition of calendar quarter, under Sec. 900.2(f), that 
establishes the endpoints of the 4 quarters as March 31, June 30, 
September 30, and December 31.
    c. Interim regulations
    Reference was made to the interim regulations several times in the 
final regulations. For the benefit of those unfamiliar with those 
regulations, FDA defined them by citing, under Sec. 900.2(t) of the 
final regulations, the Federal Register publication of December 21, 
1993, as amended on September 30, 1994.
    d. Interpreting physician
    This definition was modified from the proposed definition by adding 
the term ``licensed'' in order to clarify the intent of the statute 
that the physician maintain a valid State license to practice medicine.
    e. Qualified instructor
    During the revisions of the training requirements for radiologic 
technologists, the term ``qualified individual'' and its definition in 
Sec. 900.12(a)(2)(ii) were replaced by the term ``qualified 
instructor'' in referring to the individuals providing the training and 
the category of such individuals was expanded. These changes made it 
necessary to add, as Sec. 900.2(oo), a definition of ``qualified 
instructor'' as an individual whose training and experience adequately 
prepares him or her to carry out specified training assignments. The 
new definition also includes examples.
    f. Standard breast
    Although the term standard breast was used and defined at several 
points in the proposed regulations, it had not been included in the 
definitions section. It has now been added as Sec. 900.2(uu) in the 
final regulations.

[[Page 55874]]

E. The Accreditation Body Application (Sec. 900.3)

    In this section, FDA proposed procedures to be followed by 
organizations or agencies applying to become FDA-approved accreditation 
bodies. It also proposed criteria for evaluation and approval of 
prospective accreditation bodies.
1. General Comments on the Accreditation Process
    (Comment 94). Several comments supported portions of the rule, and 
the initial accreditation process in general, stating that it had 
elevated the quality of many facilities under the interim regulations. 
Other comments, including some from members of NMQAAC, expressed a 
variety of concerns, including possible conflict of interest and lack 
of uniformity that may result if States become certifying bodies. One 
general comment recommended that FDA monitor ACR, rather than 
facilities.
    Comments about the States as certifiers go beyond the scope of this 
document and will be addressed in future proposed regulations covering 
States as certifying agents. However, the agency notes that the MQSA 
expressly provides that States may serve as certifying bodies (42 
U.S.C. 263b(q)). Preparations are under way to draft proposed 
regulations that would govern State agencies that wish to become 
certifying bodies. Just as these final regulations establish standards 
and procedures for accreditation bodies, including State agencies that 
serve in that capacity, provisions regulating States as certifying 
bodies would establish standards and procedures that States must meet 
to assume that responsibility. Those standards and procedures would 
address uniformity of standards and include conflict of interest 
provisions, as do the regulations governing accreditation bodies.
    Members of the public will have full opportunity to comment further 
on States as certifiers when those regulations are proposed. In 
response to the comment that urged FDA to monitor ACR rather than 
facilities, the agency notes that the statute requires FDA to monitor 
both accreditation bodies and facilities in a variety of ways.
    (Comment 95). One comment wanted FDA to promote multiple 
accreditation bodies because of concerns that States approved as 
accreditation bodies will have overly stringent requirements.
     States approved as accreditation bodies are required to accredit 
facilities under the MQSA in accordance with standards that are 
substantially the same as those applied by all approved accreditation 
bodies. However, the MQSA does not prohibit State regulations from 
being more rigorous than those of FDA. Although more stringent State 
requirements cannot be used to deny accreditation under the MQSA, 
facilities may be required by a State to meet such additional 
requirements in order to practice mammography in that State.
2. The Clinical and Phantom Image Review Process 
(Sec. 900.3(b)(3)(iii)(A) and (B))
    These provisions require the prospective accreditation body to 
provide information that describes its clinical and phantom image 
review process in its application to FDA.
    (Comment 96). One comment requested that this information also be 
provided to all mammography facilities, stating that it would result in 
improved overall image quality and would assist facilities denied 
accreditation to prepare for appeals hearings.
    FDA understands that facilities may believe they could prepare 
better for accreditation review if they had details relating to the 
procedures the accreditation bodies would be applying during clinical 
and phantom image review. However, FDA also recognizes that disclosure 
of the details of such procedures may undermine the integrity of the 
review process under certain circumstances. FDA concludes that this is 
a matter for accreditation body policy rather than regulations. The 
actual clinical attributes reviewed during accreditation are described 
in the final regulations.
3. Policies and Procedures (Sec. 900.3(b)(3)(iii)(J))
    This provision requires prospective accreditation bodies to provide 
FDA with information describing policies and procedures that will 
ensure timely processing of facility applications for accreditation.
    (Comment 97). One comment on this section requested FDA to require 
accreditation bodies to respond to requests for information or to 
written communications expressing concerns from facility personnel or 
other interested parties about the accreditation process. Another 
comment suggested including a review of the consistency of the 
accreditation body's responses to facility and industry inquiries as 
part of the annual evaluation of the accreditation body by FDA.
    FDA agrees that timely processing of facility accreditation 
applications is important to meet statutory certification deadlines and 
that good communication between accreditation bodies and facilities can 
improve such timeliness. However, FDA disagrees that specific 
prescriptive regulations are needed concerning communications between 
the accreditation body and facilities.
4. Education and Experience Criteria (Sec. 900.3(b)(3)(iv))
    (Comment 98). One comment stated that this subparagraph, requiring 
that prospective accreditation bodies provide information describing 
education and experience criteria for its staff, fails to specify 
minimum acceptable values for these criteria. It also asked for 
clarification of ``professional staff.''
    By professional staff, FDA means those persons evaluating and 
making decisions on accreditation applications. FDA has established 
minimum requirements for the clinical image reviewers under 
Sec. 900.4(c)(5) and for phantom image reviewers under 
Sec. 900.4(d)(5), but has not issued minimum requirements for other 
accreditation body staff in order to maintain flexibility for 
accreditation bodies and to be able to consider alternatives on a case 
by case basis. FDA's experience under the interim regulations is that 
every professional member of an accreditation body staff is qualified 
to perform his or her assigned functions.
5. Resources (Sec. 900.3(b)(3)(vi))
    This provision requires prospective accreditation bodies to provide 
information in their application to aid FDA in determining if the body 
has adequate resources to carry out its responsibilities.
    (Comment 99). One comment asked what constitutes adequate funding, 
what specific additional resources are required and in what amount, and 
how FDA expects to evaluate the adequacy of an application if no 
minimum requirements exist for such resources.
    Funding and other resource needs, e.g., personnel and data systems, 
are a function of the variable conditions under which accreditation 
bodies may operate and the populations they may serve.
    FDA could not establish rigid funding or staffing requirements to 
apply to every accreditation body applicant. As issued, the regulations 
provide FDA with authority to obtain information to evaluate the 
individual circumstances of each applicant.
6. Other Information (Sec. 900.3(b)(3)(xiii))
    This subparagraph requires a prospective accreditation body to 
provide any information required by FDA beyond that specifically listed 
in Sec. 900.3(b)(3).
    (Comment 100). One comment described this requirement as 
exceedingly vague and recommended it be deleted.

[[Page 55875]]

    FDA must reject this suggestion because the requirements that 
accreditation bodies provide FDA with additional information is in the 
statute itself (42 U.S.C. 263b(e)(1)(vii)). The drafters of the MQSA 
recognized that it would be impossible to foresee in advance when 
circumstances might create the need for additional information.
    FDA has added one provision to Sec. 900.3(b)(3) to obtain 
information from prospective accreditation bodies about procedures and 
policies they would implement to protect confidential information. This 
requirement is at Sec. 900.3(b)(3)(ix) and its addition has caused the 
subsequent sections to be renumbered.
7. Term of Approval (Sec. 900.3(g))
    (Comment 101). A small number of comments, both pro and con, were 
received concerning the accreditation body's term of approval, proposed 
by FDA to be 5 years. Some, including members of NMQAAC, stated that 
this term was too short, particularly in light of FDA's annual 
accreditation body evaluation. These comments also expressed concern 
about the amount of paperwork required for renewal.
    In response to these concerns, FDA has increased the renewal period 
in the final regulation to 7 years. Because FDA shares the concern 
about the amount of paperwork required for renewal of accreditation 
body approval, the agency plans to limit the data required to be 
submitted to only that information necessary to justify renewal. FDA 
will hold discussions with each accreditation body prior to renewal to 
identify the information that will be required. Such information may 
include, but is not limited to, information and data pertaining to the 
accreditation body's program not previously submitted to FDA and all 
proposed changes to the accreditation body's program or standards.

F. Standards for Accreditation Bodies (Sec. 900.4)

    Accreditation bodies are responsible for the initial screening of 
mammography facilities. They are to ensure that the facilities they 
accredit meet the quality standards established by FDA, both initially 
and on an ongoing basis. They also have unique responsibility for 
conducting reviews of clinical images from the facilities to determine 
if the images meet the image quality standards established by the 
accreditation body with FDA approval. This section of the regulations 
outlines the requirements that FDA-approved accreditation bodies must 
meet in carrying out these responsibilities.
1. General Comments on the Standards for Accreditation
    (Comment 102). One comment generally supported this section as 
written, while a second applauded the regulations for not requiring 
specific measures of interpretive performance. Other comments 
encouraged FDA to add additional requirements and responsibilities for 
accreditation bodies, but did not identify what these should be. One 
comment stated that the proposed rules for accreditation bodies 
suffered from a lack of either design or performance-based criteria, 
but failed to suggest any design or performance-based criteria that 
should be applied.
    FDA believes that the final regulations governing accreditation 
bodies are sufficiently detailed without being overly prescriptive. 
Although particular performance-based requirements were not identified 
by these comments, FDA notes that some performance data on 
accreditation body activities are available and are used by FDA in its 
annual evaluation of each accreditation body.
    (Comment 103). One comment recommended that each accreditation body 
be required to demonstrate expertise in recordkeeping and epidemiology.
    FDA believes that its review of the accreditation body's 
application will provide sufficient information to establish that the 
accreditation body has recordkeeping capability. Although accreditation 
bodies may employ epidemiologists, nothing in the MQSA suggests that 
FDA should make this a requirement.
    (Comment 104). One comment stated that excessive requirements for 
accreditation bodies will destroy the basic concept behind the idea for 
accreditation bodies, i.e., significant involvement of the public and 
professional sector. The comment warned that detailed rules could 
reduce the opportunity for creative approaches and innovative 
development of new QC tests and procedures. A second comment stated 
that FDA should not hinder the accreditation bodies from performing as 
independent entities.
    FDA shares concerns that overly detailed requirements may limit 
professional involvement and useful innovation. Although it may appear 
that the final regulations include many new requirements for 
accreditation bodies, to a large extent the provisions reflect 
procedures and criteria that the current accreditation bodies already 
are following under the interim regulations. In fact, many were first 
devised by the accreditation bodies themselves and are examples of 
accreditation body innovation, e.g., development, submission, 
evaluation, and monitoring completion of corrective action plans by 
facilities found to have problems producing quality mammograms. FDA has 
taken great care to delete or amend requirements that might limit 
creative approaches and innovation. Because the comment does not 
identify specific rules in the proposal that might cause such problems, 
the agency cannot respond further.
    In response to the second comment, the agency notes that the MQSA 
requires FDA to establish standards for, and to approve accreditation 
bodies. Entities that apply to become accreditation bodies must comply 
with those standards. FDA does not believe that compliance with those 
standards will diminish the ability and obligation of accreditation 
bodies to make independent professional judgments. Those judgments, 
however, must be consistent with statutory obligations to ensure that 
facilities comply with the Federal standards and work with FDA to 
improve the practice of mammography. Accreditation bodies are free to 
encourage innovation, conduct research, develop new standards, and 
apply for appropriate variances when a particular practice or procedure 
presents an opportunity to enhance mammography quality.
2. Code of Conduct and General Responsibilities (Sec. 900.4(a))
    These provisions were intended to describe the responsibilities of 
the accreditation body when there is a possibility that mammography 
practice at an accredited facility poses a risk to human health. As 
proposed, those sections set forth particular actions an accreditation 
body would be required to take in those circumstances.
    a. Image quality (Sec. 900.4(a)(1) and (a)(2))
    (Comment 105). One comment stated that the accreditation body 
should have the discretion to determine the appropriate review for a 
given circumstance and the option to initiate other actions FDA had not 
described in the proposal (e.g., random film checks followed by a site 
visit, if necessary). Three other comments recommended deletion of 
these paragraphs and the substitution of guidance documents that would 
give accreditation bodies more flexibility.
    FDA generally agrees with these comments and has eliminated most of 
the detailed provisions of these paragraphs (including all of proposed 
paragraph Sec. 900.4(a)(2)). The final provisions establish that the 
accreditation body has a responsibility to review clinical images or 
other

[[Page 55876]]

aspects of a facility's practice any time it obtains or receives 
information that suggests a facility is not in compliance with the MQSA 
standards, or upon request from FDA. The accreditation body also has 
responsibility to require and monitor corrective actions or to suspend 
or revoke a facility's accreditation if the accreditation body's, or 
FDA's, review confirms that a problem exists. These responsibilities 
are integral to the role accreditation bodies play under the MQSA to 
assist the government in establishing and monitoring quality standards 
for mammography. Nothing in the final regulations precludes an 
accreditation body from initiating investigations on its own.
    b. Equipment or practices that pose a serious risk 
(Sec. 900.4(a)(2))
    (Comment 106). Six comments recommended changing the requirement 
that an accreditation body inform FDA on becoming aware of situations 
of potentially serious risk to the public health from ``within 5 
business days'' to ``the next business day.''
     FDA agrees with concerns raised by these comments and has changed 
the requirement to ``as soon as possible but in no case later than 2 
business days.'' The standard that triggers such responses has been 
amended to those that ``pose a serious risk to human health'' in order 
to ensure that FDA is informed of all problems that may require 
immediate followup.
    c. Conflict of interest (Sec. 900.4(a)(4))
    The goal of this provision was to ensure that actions of the 
accreditation body's clinical or phantom image reviewers were not 
affected by any conflict of interest, and to ensure that accreditation 
bodies avoid the appearance of such conflicts in order to establish and 
maintain confidence in the accreditation process.
    (Comment 107). Four comments recommended expanding clinical image 
reviewer conflict of interest concerns to include the individual's 
family, corporations, partnerships, and associations.
    FDA disagrees with these comments. The comments provided no 
arguments to support this recommendation and no evidence to suggest 
that the present conflict of interest provision is inadequate. In 
addition, FDA believes limitations suggested by the comment would 
eliminate some highly qualified clinical image reviewers from 
eligibility without commensurate benefit to the system. The agency 
notes that, if similar conflict of interest provisions had been applied 
to membership on NMQAAC, many of the members that played a major role 
in developing final regulations would not have been eligible to serve 
on the committee.
    (Comment 108). One comment recommended expanding the conflict of 
interest provision to specify that clinical and phantom image reviewers 
must not review images from facilities within the State in which they 
reside. A second comment also expressed concern about clinical image 
reviewers evaluating images from their own States or geographically 
limited areas. The comment proposed that FDA require ``blind'' readings 
of all images by reviewers and prohibit review if there is potential 
conflict of interest.
    FDA disagrees with the suggestion that reviewers should be barred 
from reviewing images from the State in which the reviewer resides. 
Such a requirement would effectively preclude State accreditation 
bodies from having independent clinical image review programs. All 
present State accreditation bodies with independent clinical image 
review programs require and take measures to ensure blind reading to 
preclude bias, and FDA expects that any future State or national 
accreditation bodies will have similar safeguards as part of their QC, 
clinical image review, and conflict of interest standards.
    (Comment 109). One comment recommended that ACR and any other 
professional organizations acting as accreditation bodies randomly 
select clinical image reviewers and phantom image reviewers from a pool 
to reduce the possibility of reviewer bias.
     FDA agrees in principle that accreditation body reviews should not 
be biased, but finds no compelling reason to require use of pools and 
random selection. Under the MQSA, FDA has issued minimum requirements 
for all interpreting physicians and these requirements apply to any 
clinical image reviewer employed by an accreditation body. In addition, 
with these provisions, FDA is requiring each accreditation body to 
establish and implement procedures to train and evaluate its reviewers 
and to avoid conflict of interest. Within this framework, FDA concludes 
that the assignment of clinical image reviewers for any applicant 
facility is best left to the accreditation body.
    d. Equipment performance and design characteristics 
(Sec. 900.4(a)(5))
     These provisions are intended to prevent conflict of interest 
situations that could arise if the use of specific products were 
required by an accreditation body as a condition of accreditation.
    (Comment 110). One comment stated that there may be an appearance 
of a conflict of interest by accreditation bodies in these situations 
and that special care must be taken with respect to the promotion of 
any product. The comment expressed the conclusion that the possibility 
of conflict is so great that it should never be acceptable for an 
accreditation body to require use of a particular product. A related 
comment stated that the accreditation bodies should not be able to 
require use of their own products by facilities they accredit. Over 15 
additional comments opposed allowing the accreditation bodies to 
require the use of their products as a condition of accreditation or 
otherwise opposed commercial activities that would create a conflict of 
interest.
    FDA understands the concerns expressed in these comments and notes 
that, in general, the regulation has been written to preclude 
accreditation bodies from requiring use of any specific brand or 
product. However, the agency believes exceptional situations may 
develop that warrant use of a particular product because of the public 
health benefits the product provides. The final regulation, therefore, 
gives FDA the flexibility to permit accreditation bodies to require the 
use of a specific commercial product when the agency has determined 
that such use is in the best interest of the public health.
    (Comment 111). A few stated that conflict of interest requirements 
should not be an impediment to development of new technologies and 
services, nor be used by other entities to ``harass'' ACR and 
improperly influence FDA.
    FDA agrees that conflict of interest provisions should not impede 
the development of new technologies, but also believes that it would 
undermine the integrity of the accreditation process if accreditation 
bodies could require facilities to use products the accreditation body 
develops as a condition of accreditation. FDA believes that the final 
regulations strike the proper balance between these competing 
interests.
    (Comment 112). Over 150 comments on identical printed forms stated 
that FDA should prohibit conflicts of interest by accreditation bodies 
and should adopt the conflict of interest provision suggested by a 
trade association and included in the preamble to the final regulations 
(61 FR 14487).
    FDA agrees that conflicts of interest by accreditation bodies 
stemming from accreditation body requirements to use specific products 
or services should be prohibited. However, none of these 150 comments 
offered arguments to support adopting the suggested provision or to 
explain why the agency's proposal was inadequate. FDA's experience 
under the

[[Page 55877]]

interim regulations demonstrates that potential conflicts can be 
addressed satisfactorily by the provisions of Sec. 900.4(a)(6). The 
suggested conflict provision would effectively preclude development of 
products and services by an accreditation body. FDA believes that 
because accreditation bodies possess particular experience and 
expertise, such products and services have the potential to enhance 
practice or otherwise be beneficial to public health. For these 
reasons, FDA has concluded that it is unnecessary and would be 
inadvisable to adopt the suggested conflict provision.
    (Comment 113). One comment stated that only FDA, as opposed to 
accreditation bodies or other entities, should be able to require the 
use of particular mammography related products and, if FDA does so, the 
use of such products should be required of all facilities.
    FDA agrees with this comment as a general rule. However, FDA may 
approve the imposition of such a requirement by an accreditation body 
if the agency determines that it is in the best interest of public 
health to do so. Such an accreditation requirement would only apply to 
facilities accredited by the accreditation body that requested the 
approval unless FDA determined that adoption of the same requirement by 
all accreditation bodies was in the best interest of quality 
mammography.
    (Comment 114). One comment requested clarification on the use of 
the word ``product,'' apparently asking whether the word was intended 
to apply to a specific item or a general category of products.
    FDA believes that the word ``product'' is commonly understood. The 
conflict of interest provisions prohibiting an accreditation body from 
requiring a product to be used can apply to several product categories 
or to specific brands or products, depending on the circumstances.
    (Comment 115). Finally, one comment made several suggestions 
related to these provisions. The comment contained the recommendations 
that FDA should require of accreditation bodies that: (1) Their 
accreditation and onsite inspections be managed by different 
departments; (2) their clinical image reviewers not review images from 
facilities in their home State to avoid a range of potential conflicts 
of interest; (3) reciprocity agreements between adjacent States be 
precluded; and (4) they meet at least the minimum standards of 
operation of the ACR program.
    FDA believes that the internal division of responsibilities within 
accreditation bodies is not appropriate for regulation; many 
professional and government agencies have dual responsibilities for 
accreditation and inspection and are able to carry out those 
responsibilities fairly and effectively without necessarily using 
different departments. It was noted previously that the second 
suggestion was not accepted by FDA because it would effectively 
preclude State accreditation bodies from having independent clinical 
review programs. Because the third suggestion does not identify or 
otherwise describe the reciprocity agreements intended to be 
prohibited, the agency cannot respond. In answer to the last 
suggestion, FDA notes that all accreditation bodies are required to 
meet the final regulations governing accreditation bodies in order to 
become approved and maintain their accreditation authority. FDA will 
not approve any accreditation body that does not have standards of 
operation that ensure the accreditation body can meet its obligations 
under the MQSA. Nothing in the MQSA precludes ACR or any other 
accreditation body from having additional standards for aspects of 
mammography that are not within the scope of the MQSA. Nor does the 
MQSA impinge on a State's ability to enforce its own standards under 
State authority if those standards are at least as stringent as the 
MQSA's.
    e. Denial of accreditation to a facility (Sec. 900.4(a)(7))
    This paragraph was intended to ensure that no State accreditation 
body could bar facilities in that State from being accredited under the 
MQSA by any other FDA-approved accreditation body.
    (Comment 116). Several comments raised questions that made it 
evident that this section was unclear as proposed. Comments asked 
whether a State accreditation body could require or restrict facilities 
within that State to accreditation by the State accreditation body. 
Other comments asked whether facilities could have more than one 
accreditation. This section has been rewritten so that the answers to 
both questions should be unambiguous.
    As revised, the provision clearly states that no accreditation body 
can require a facility to be accredited by that accreditation body if 
more than one accreditation body is available. Nor can an accreditation 
body preclude a facility from being accredited by any other available 
accreditation body. Consequently, nothing in the final regulations 
prevents a facility from having more than one accreditation. However, 
FDA will issue only one certificate, usually based on the initial 
accreditation.
    The geographic scope of authority for an accreditation body will be 
established through the accreditation body approval process. A State 
certainly could determine, as all current State accreditation bodies 
have, to restrict accreditation body activities to facilities within 
the State. A non-State accreditation body similarly could request to be 
approved to accredit in a limited geographic area. It would be up to 
the applicant to initially identify, based on its circumstances and 
resources, the area it intends to serve. In addition, FDA could 
restrict the scope of an accreditation body's authority to a 
geographical area that is smaller than that desired by the 
accreditation body if, for example, the agency had doubts about the 
ability of the accreditation body to provide adequate service in the 
desired area.
    (Comment 117). One comment asserted that a State government cannot 
be restricted at any time from requiring its own accreditation 
guidelines to be met by facilities in that State.
     FDA agrees that States may require facilities to meet standards 
under State law that are at least as stringent as those under the MQSA. 
However, such standards may not be required as a condition for 
accreditation under the MQSA.
    One comment expressed the view that this provision was unnecessary 
because a facility accredited by a State agency would not voluntarily 
seek accreditation elsewhere. FDA disagrees with this comment. A small 
number of facilities have sought and received dual accreditation. In 
addition, the main point of the provision is to ensure that facilities 
are able to seek initial and exclusive accreditation under the MQSA 
from another accreditation body, even if the State acts as an 
accreditation body in their geographic area.
    f. Changes to standards (Sec. 900.4(a)(8))
    (Comment 118). FDA received two comments on this section, which 
requires an accreditation body to obtain FDA permission prior to 
changing any standards previously accepted by the agency. Both comments 
were generally supportive of the provision. One comment suggested 
verifying whether current technology is capable of meeting the 
requirements for any change in standards before the change is made. 
This will serve to minimize costs for both facilities and industry.
    FDA agrees with this comment and routinely considers the adequacy 
of current technology during development of new standards or evaluation 
of

[[Page 55878]]

standards proposed by the accreditation bodies.
    (Comment 119). One comment further stated that any proposed change 
to any standard by an accreditation body should be supported by 
scientific data and that FDA should seek industry input before 
authorizing the change. FDA agrees that changes in standards, and 
especially technical standards, benefit from the application of 
scientific data, where possible. The agency further agrees that 
industry input is often useful. However, FDA believes that, in many 
circumstances, the information already available to the agency is 
sufficient for a decision and that additional scientific data and 
outside comment will not be necessary. Therefore, FDA did not make this 
a regulatory requirement.
    g. Confidential information (Sec. 900.4(a)(9))
    This paragraph requires the accreditation bodies to establish 
procedures to protect confidential information.
    (Comment 120). Ten comments asked how FDA will ensure that 
confidentiality will be maintained.
    The intent of this provision is to guarantee that each 
accreditation body has in place procedures, programs, and systems that 
train employees to guard against unauthorized disclosure of 
information. Federal regulations, State laws, and contractual 
obligations will all play a part in determining an accreditation body's 
responsibility in any particular situation. In general, however, if FDA 
shares nonpublic information with an accreditation body about a 
particular facility, the record containing that information is an 
agency record under the control of FDA and the accreditation body would 
not be authorized to disclose that information without the permission 
of the agency. If an accreditation body, in violation of the final 
regulations, were to improperly use or disclose information received 
from a facility for purposes of accreditation, FDA believes the 
facility would have a private right of action against the accreditation 
body under the laws of most States. In addition, unauthorized 
disclosures of information, whether received from FDA or the facility, 
would be a basis for FDA to withdraw an accreditation body's approval. 
Nothing in these regulations, however, is intended to preclude or 
hinder the exchange of information between FDA and accreditation bodies 
when that information is required to be shared in order for the agency 
and the accreditation body to carry out functions under the statute.
    (Comment 121). Three comments recommended allowing accreditation 
bodies to use and disclose information gathered during the 
accreditation process, if the identification of an individual, 
facility, or group is not compromised. Each comment cited the Freedom 
of Information Act (FOIA). A similar comment found this regulation to 
be overly restrictive, and stated that the regulation should allow use 
of the data for research purposes, ``so long as the released data 
involves only pooled information that does not allow identification of 
an individual, facility, or group.''
    FDA generally agrees with these comments. Disclosure of aggregate 
information that does not reveal, directly or indirectly, the identity 
of particular facilities or individuals, is consistent with the FDA's 
regulations implementing the FOIA. However, in the event of ambiguity, 
accreditation bodies would consult with FDA and obtain clearance before 
making such disclosures. FDA does not believe data obtained from 
facilities for accreditation purposes should be used for purposes that 
have no relationship to accreditation body processes or standards, 
unless the accreditation body obtains the consent of the facility. This 
would not impede an accreditation body from using data to review and 
improve its internal processes, to educate personnel to improve 
accreditation body efficiency and performance, or to publicly discuss 
results of the processes using aggregate data.
    (Comment 122). One comment noted that all data collected by or 
emanating from State agencies may be releasable under some State laws, 
and that nonpublic information is not necessary for accreditation. The 
comment also sought clarification about what would be deemed nonpublic 
information. A second comment stated that, in Arkansas, all information 
received by a publicly funded agency for accreditation review is 
releasable under that State's Freedom of Information (FOI) laws. A 
third comment, which also requested clarification on public versus 
nonpublic information, suggested that public information be limited to 
name, address, phone, and accreditation status. The comment noted that 
there have been complaints from radiologists about the use of 
information, including concerns about selling the MQSA certified 
facility address list.
    FDA recognizes that people have varying ideas about what 
constitutes nonpublic information. Any information in the possession of 
FDA that is prohibited from disclosure under various statutes FDA 
enforces or that is exempt from mandatory disclosure under the FOIA is 
considered nonpublic information by the agency. Examples of such 
nonpublic information include data about the volume of business handled 
by any particular facility, the name or personal identifier of any 
mammography patient, and internal recommendations for enforcement 
action. FDA would not make such information public in response to a 
request for information under the FOIA.
    As stated previously, accreditation bodies that obtain nonpublic 
information from FDA will be required to treat it as an FDA record and 
protect it accordingly. If an accreditation body obtains similar 
information from other sources, FDA expects the information will 
receive similar protection in the vast majority of cases. FDA has had 
public information regulations in place implementing the FOIA since 
1977. During those years, FDA has found that State confidentiality laws 
are usually consistent with FDA's requirements. Arkansas' FOI law, 
e.g., which was cited by one comment, has provisions for exceptions to 
mandatory public disclosure that are similar to the Federal FOIA and 
FDA's implementing regulations. In situations where the accreditation 
body believes that State law requires disclosure of information that 
would be considered confidential if it were part of an FDA record, 
every effort will be made to consult State authorities and resolve the 
apparent inconsistencies.
    In addition, FDA notes that all the currently approved 
accreditation bodies have had experience handling sensitive nonpublic 
information. ACR has done so for many years and, since the beginning of 
its voluntary MAP in 1987, has handled and processed information very 
similar to that required under the MQSA. The State accreditation bodies 
also have broad experience processing and protecting sensitive 
information because they have had previous responsibility regulating 
facilities under their own State laws. FDA has no evidence that any 
accreditation body has improperly disclosed information.
    With respect to the comment that complained about the sale of a 
list of certified facilities, FDA notes that this sale was not by an 
accreditation body, and that the names and addresses of certified 
facilities would not, in any case, be nonpublic information. The list 
is available from NTIS for a nominal charge to cover the cost of 
reproduction and is also available from the Center for Devices and 
Radiological Health Internet site.
    (Comment 123). Ten comments stated that permission to disclose 
nonpublic

[[Page 55879]]

information should rest with the facility, not FDA.
    The final regulations are consistent with these comments. An 
accreditation body may not disclose to the public any nonpublic 
information it has obtained from a facility without the permission of 
that facility. If an accreditation body has obtained information about 
a facility from FDA or its duly designated representatives, including a 
State agency with responsibility for monitoring mammography facilities, 
the accreditation body cannot further disclose that information without 
the written permission of FDA. Because FDA is obligated to protect 
nonpublic information, it would not authorize release of information 
about any facility that was entitled to be protected from disclosure 
under the Federal law. FDA has added references in the final 
regulations to information obtained from or provided to State agencies 
because FDA's experience under the interim regulations demonstrates the 
necessity for sharing information among accreditation bodies, State 
authorities, and FDA in order to ensure quality mammography.
3. Facility Standards (Sec. 900.4(b))
    This section outlined the responsibilities accreditation bodies 
must meet to ensure that facilities they accredit meet the FDA quality 
standards.
    a. General comments on facility standards
    (Comment 124). Seven comments requested that FDA add an additional 
provision to state, ``The accreditation body shall review previous 
inspection reports prior to issuing full accreditation.'' Eight 
additional comments recommended adding that sentence, plus the 
additional words, ``to previously accredited facilities'' at the end.
    FDA appreciates the concerns of these comments that accreditation 
bodies have access to complete information about facilities that are 
applying for accreditation for the first time or to renew their 
accreditation. FDA disagrees that accreditation bodies should be 
required to review all prior inspection reports for every application 
it receives. Such a requirement could raise accreditation costs 
unnecessarily, and the prior accreditation history that each facility 
must submit with its accreditation application will provide a summary 
of significant related information. However, FDA encourages 
accreditation bodies to request inspection records from FDA whenever 
the accreditation body believes that such records would aid in review 
of an accreditation application.
    b. Monitoring facility compliance (Sec. 900.4(b)(1))
    Under this provision, an accreditation body must require each 
facility it accredits to meet quality standards that are substantially 
the same as those required by FDA.
    (Comment 125). Six comments recommended using this provision to 
make the accreditation bodies responsible for reviewing continuing 
education and other personnel requirements, thereby eliminating 
verification of these personnel standards from the annual inspections.
    FDA notes that the accreditation bodies have the responsibility 
under the interim regulations to ensure that personnel qualifications 
are met before they accredit a facility and will continue to have that 
responsibility under the final regulations. However, the number of 
personnel noncompliances found during inspections over the last 2 years 
illustrates the value of an onsite check of these qualifications. As 
experience with inspection and accreditation activities develop, FDA is 
working with the accreditation bodies to improve and enhance the role 
each plays in oversight of facility compliance with quality standards.
    (Comment 126). One comment recommended replacing ``substantially 
the same'' with ``the same'' to ensure clarity.
    FDA disagrees with this comment. The MQSA does not contemplate that 
the standards be identical; the statute uses the phrase ``equal to'' 
(42 U.S.C. 263b(e)(1)(B)(vi)). Using ``the same'' would unduly restrict 
accreditation bodies, and effectively preclude relatively minor 
differences that are necessary or appropriate because of different or 
changing circumstances among accreditation bodies.
    c. Facility compliance (Sec. 900.4(b)(2))
    (Comment 127). One comment stated that accreditation bodies should 
not be required to ensure that a facility correct noncompliances 
because accreditation bodies have no authority in these matters. 
Instead, the comment suggested that accreditation bodies be required to 
refer enforcement matters to FDA or, in the future, to a State 
certifying entity.
    As discussed previously, FDA agrees that enforcement matters are 
ultimately the responsibility of the agency. This provision has been 
modified accordingly. As discussed previously (see section III.F.1 of 
this document), accreditation bodies have responsibility and authority 
to monitor compliance with standards and to suspend or revoke 
accreditation of facilities that do not maintain standards.
4. Clinical Image Review (Sec. 900.4(c))
    FDA believes that effective clinical image review is essential for 
high quality mammograms. A primary purpose of the MQSA is to ensure 
that all mammography facilities have the benefit of such review and 
that accreditation bodies are qualified to perform that function. 
Accordingly, FDA proposed more specific requirements with respect to 
clinical image review than were established under the interim 
regulations. The proposed requirements, which were based on advice from 
NMQAAC and public comments, have been codified without significant 
changes in the final rule.
    The regulations define three separate but related types of clinical 
image review. They are accreditation and reaccreditation clinical image 
review, random clinical image review, and additional mammography 
review. Each serves a different purpose within the framework of the 
MQSA and the regulations.
    Accreditation and reaccreditation clinical image review is 
performed for each facility once every 3 years. Its purpose is to 
ensure that each facility is capable of producing and recognizing high 
quality images of fatty and dense breasts. Section 900.4(c) has been 
retitled in the final regulations from the general title that had been 
proposed, ``Clinical image review,'' to ``Clinical image review for 
accreditation and reaccreditation'' to clarify that the provisions of 
this section refer specifically to clinical image reviews performed for 
accreditation and reaccreditation.
    In addition to clinical image review performed for routine 
accreditation and reaccreditation, the MQSA also requires the 
accreditation body to conduct random clinical image review. This type 
of review is performed on a selected sample of the accreditation body's 
facilities and serves three major purposes. Random clinical image 
review is an indicator of the quality of mammography performed at 
facilities, a measure of the performance of the accreditation body, and 
a method to assure the public that facilities continue to produce high 
quality images during the intervals between reaccreditation reviews. 
Under the provisions of Sec. 900.4(f)(2), FDA is allowing each 
accreditation body to develop its own FDA-approved random clinical 
image review process to include at least 3 percent of its accredited 
facilities each year. This enables each body to individualize the 
review to best evaluate its facilities and monitor its own performance. 
While the accreditation bodies will be evaluating the same

[[Page 55880]]

attributes used for accreditation and reaccreditation clinical image 
review, they will have to adjust their scoring and pass-fail criteria 
to take into account that, due to the selection process, these studies 
may not be representative of the best images a facility can produce.
    The third type of review is additional mammography review. This 
review is an evaluation of facilities that FDA has reason to believe 
may present a serious risk to human health due to compromised 
mammography quality. The term ``additional clinical image review,'' 
used in the proposal, was changed to ``additional mammography review'' 
to indicate that this review of problem facilities is not necessarily 
limited to an evaluation of clinical images but can involve all aspects 
of mammography at the facility. The requirements for this type of 
review are provided in Sec. 900.12(j).
    a. Frequency of clinical image review (Sec. 900.4(c)(1))
    Section 900.4(c)(1) states that clinical image review for 
accreditation and reaccreditation shall be performed at least once 
every 3 years. This is in accordance with the requirements specified by 
the MQSA.
    b. Attribute requirements (Sec. 900.4(c)(2))
    Section 900.4(c)(2) lists the eight attributes to be used for 
evaluating clinical images.
    (Comment 128). One comment agreed with the section as proposed, 
while another comment thought it was too proscriptive and did not allow 
for changes in technology and assessment. Two other comments stated 
that the attributes were too vague, while another said that the 
attributes should be identical to any existing standards and 
definitions currently in use.
    FDA notes that the attributes described in Sec. 900.4(c)(2) were 
derived from existing standards that have been used successfully for 
mammographic evaluation for many years. Accreditation bodies are 
currently using these attributes to evaluate clinical images under the 
interim regulations. FDA does not believe the use of these attributes 
will limit the introduction of new technologies because FDA has the 
flexibility to modify the attributes for new mammographic modalities, 
if necessary.
    (Comment 129). One comment recommended that the contrast, 
sharpness, and noise attributes should be dropped because all 
mammograms contain some blurring and noise.
    FDA agrees that some degree of blurring and noise occur on all 
films. However, these attributes should be evaluated to determine if 
the blurring or noise are of such severity as to obscure anatomical 
structures.
    (Comment 130). Several comments addressed specific attributes. One 
comment stated that the positioning attribute implies that it is not 
necessary to get all the breast tissue on the film.
    FDA notes that, due to anatomical and mammographic limitations, all 
breast tissue cannot be imaged on each view. The requirement was 
specifically written by FDA to take this fact into account.
    (Comment 131). Several comments, including one from NMQAAC, urged 
that the word ``tissue'' be replaced with ``image'' when referring to 
exposure and that ``processing'' should be added to the list of 
``artifacts.''
    FDA agrees that ``processing'' should be added to the list of 
``artifacts'' and has changed ``tissue exposure'' to ``exposure level'' 
to be more consistent with existing standards and definitions.
    (Comment 132). One comment was unclear as to whether ``noise'' was 
the same as ``quantum mottle.'' FDA notes that ``quantum mottle'' is a 
form of ``noise,'' although it is not the only form of ``noise.''
    (Comment 133). Several comments opposed the examination 
identification attribute as being too specific and requiring too much 
information to be placed in the small flasher space. Two comments 
supported the description of the attribute as written.
    FDA has received a great deal of advice from NMQAAC regarding the 
importance of examination identification as an attribute of quality 
mammography and believes that the present requirement is in the best 
interest of the patient. A facility may satisfy the requirements for 
examination identification through the use of stick-on labels so that 
all the information does not have to fit within the flasher space. 
NMQAAC recommended specifically adding the name and an additional 
identifier to patient identification. FDA agrees with this suggestion 
and has modified this section accordingly.
    (Comment 134). One comment stated that technical factors such as 
kVp, milliamperes (mA's), and amount of compression should be required 
on all films because this information would aid in evaluating problems. 
It noted that ACR recommends recording these technical factors.
    FDA believes that facilities should have the option of recording 
this information if they believe it beneficial for their practice. 
Because many facilities have indicated that having this information on 
all images is not useful, the agency does not believe it is cost 
effective to make this a mandatory requirement for all facilities.
    (Comment 135). Two comments, and several members of NMQAAC, stated 
that FDA must ensure that accreditation bodies prevent reviewers from 
knowing the identity of the facility under review, especially in the 
case of local reviewers.
    FDA agrees that this is an important issue and has discussed it in 
response to comments on Sec. 900.4(a)(4), which addresses possible 
conflicts of interest by image reviewers.
    (Comment 136). One comment asked if the technologist identification 
is meant to be unique for a facility, for a particular health 
corporation, or nationally recognized. The technologist identification 
requirement is facility-based and any system that enables the facility 
to determine which technologist performed the examination should be 
acceptable.
    (Comment 137). One comment agreed that mammography unit 
identification was important for reproducibility, while another asked 
whether it would be possible to have the unit identification on the 
patient's question and answer form rather than on the film.
    FDA believes that, in cases where there is more than one unit in 
the facility, the unit identification should be on the film, so that 
this information may be obtained without referring to other sources.
    c. Scoring clinical images (Sec. 900.4(c)(3))
    Section 900.4(c)(3) requires the accreditation body to establish a 
system for scoring clinical images using the attributes in 
Sec. 900.4(c)(2) and to develop pass-fail criteria for these 
attributes. It also requires that images be independently reviewed by 
two or more clinical image reviewers. This section was modified from 
the proposal to clarify that each attribute shall be individually 
evaluated.
    (Comment 138). One comment warned that perfectly acceptable images 
can be rejected by the clinical image review process if a pass-fail 
system is used. The author believed that there should be some form of 
grading system for the evaluation of the films.
    FDA agrees that a grading system should be employed in evaluating 
the studies. A requirement for such a system was in the proposed 
regulations. It has been modified in the final regulations to require 
that acceptable and unacceptable results be established for each of the 
eight attributes and an overall pass-fail system. This change ensures 
that each facility has the benefit of an evaluation of each attribute, 
providing the facility with the

[[Page 55881]]

information essential to take appropriate corrective actions when 
necessary. FDA's experience under the interim regulations indicates 
that failure by the clinical image review process of what are later 
judged to be acceptable images is an unusual occurrence. In those rare 
cases where the facility disputes an accreditation body clinical image 
review decision, the facility has the option of appealing this adverse 
decision to the accreditation body and then to FDA.
    (Comment 139). One comment said that the specific details of the 
scoring process should be made public, utilized in an identical manner 
by all accreditation bodies, be verified, and result in a numerical 
score for each set of films reviewed. FDA notes that the determinants 
of high image quality mammography have already been made public by 
accreditation bodies, professional organizations, and by clinical 
authors publishing in peer review radiology journals. This information 
should be incorporated into each facility's quality assurance program 
and should be used for selecting the studies that are submitted to the 
accreditation body for clinical image review. FDA believes that the 
specific details of the accreditation body's scoring procedures should 
remain confidential to preserve the integrity of the process. However, 
the details will be reviewed and evaluated by the agency as part of 
FDA's approval and oversight responsibilities.
    d. Selection of clinical images for review (Sec. 900.4(c)(4))
    Section 900.4(c)(4) describes the number and types of images that 
shall be submitted by the facility for accreditation and 
reaccreditation clinical image review.
    (Comment 140). Four comments stated that accreditation and 
reaccreditation clinical image review should be done on randomly 
selected images rather than the ``best'' images a facility can produce, 
arguing that this would give a better indication of the quality of 
mammography being performed. One comment agreed with Sec. 900.4(c)(4) 
as proposed, but suggested adding one randomly selected set of images. 
One comment mistakenly believed that FDA was allowing accreditation 
bodies to use either random or nonrandom selection of clinical images 
for accreditation or reaccreditation clinical image review.
    FDA has retained the provision that accreditation and 
reaccreditation clinical image review is to be performed using the 
``best'' images a facility can produce. Using this criterion for 
selection allows the accreditation body to apply its highest standards 
to the scoring of these images. It also serves as a check on facility 
personnel to see if they understand what makes a high quality image. 
Random clinical image review, as required in Sec. 900.4(f), serves a 
different purpose than accreditation and reaccreditation clinical image 
review. Although the accreditation body evaluates the same attributes, 
the scoring standards are more flexible to take into account that these 
may not be the ``best'' images a facility can produce.
    (Comment 141). Two comments stated that clinical image review is 
extremely valuable, but that more films should be reviewed.
    FDA disagrees. Requiring review of additional studies would serve 
to raise the cost and complexity of the review process without a 
demonstrable increase in quality. During discussions with NMQAAC, a 
majority of the committee agreed with FDA's position on this issue.
    (Comment 142). Two comments urged FDA to replace the term ``view'' 
with ``projection.''
    FDA discussed this with NMQAAC, who agreed with the agency that 
``view'' is the correct term to use in this context.
    (Comment 143). Six comments stated that clinical images for 
accreditation and reaccreditation review should be selected from a 
specified period of time. Three comments, including a consensus of 
NMQAAC, stated that both the clinical images and the phantom image 
should be from the same 30-day period.
    FDA did not set timeframes for submission of images in the 
regulations in order to allow the accreditation bodies to establish 
these timeframes based on their own circumstances and experience with 
the review process. The agency has rejected the suggestion that phantom 
and clinical images be from the same 30-day period because this could 
create logistical problems if a second set of clinical images had to be 
submitted.
    One comment expressed the author's belief that a national 
accreditation body should develop materials showing examples of 
acceptable dense and fat-replaced breast images. FDA encourages 
accreditation bodies to provide such information and education but does 
not believe that this is a matter that should be addressed in 
regulation.
    (Comment 144). Several comments, including a consensus of NMQAAC, 
stated that it is often difficult to find images that are totally 
normal and suggested that images could be sent from either negative or 
benign assessment categories.
    FDA agrees and has modified Sec. 900.4(c)(4)(iii) accordingly.
    (Comment 145). One comment suggested that Sec. 900.4(c)(4)(iv) be 
revised to allow a facility to submit alternative mammograms only if 
the facility does not have images interpreted as normal under 
Sec. 900.4(c))(4)(iii). It stated that no alternatives should be 
accepted for craniocaudal and mediolateral views required in 
Sec. 900.4(c)(4)(I) or for dense and fatty breast images required in 
Sec. 900.4(c)(4)(ii). FDA disagrees and believes that accreditation 
bodies should be given the flexibility to deal with these situations in 
an appropriate and individualized manner.
    e. Clinical image reviewers (Sec. 900.4(c)(5))
    Section 900.4(c)(5) requires the accreditation body to ensure that 
its clinical image reviewers are interpreting physicians, are trained 
and evaluated in the clinical image review process, document their 
findings and the reasons for assigning a particular score to any 
clinical image, and provide information to the facility for improving 
image quality.
    (Comment 146). Several comments, including some from NMQAAC, stated 
that criteria for clinical image reviewers should be more detailed and 
that FDA should specify a minimum training and evaluation curriculum or 
other performance-based measure. One comment stated that it was 
essential for all accreditation body clinical image reviewers to meet 
minimum standards of reliability.
    FDA notes that Sec. 900.4(c)(5) establishes the basic requirements 
for clinical image reviewers and serves as the starting point for the 
accreditation bodies to develop their own additional requirements. 
Through its oversight activities, FDA ensures that the different 
accreditation programs are internally and externally consistent. FDA 
currently monitors accreditation body policies to achieve consistency 
in critical areas. The agency has worked and continues to work with the 
accreditation bodies to enhance existing procedures and establish new 
programs to monitor inter- and intra-accreditation body consistency for 
clinical image review.
    (Comment 147). Five comments suggested that inspectors be trained 
to be clinical image reviewers. These comments reasoned that such 
training would permit a more accurate evaluation of clinical image 
quality than the current practice of letting facilities pick their best 
films for accreditation body evaluation. One of the comments contended 
that image quality would improve overall if a facility knew that

[[Page 55882]]

any image could be reviewed during inspections.
    The MQSA assigns primary responsibility for clinical image review 
to accreditation bodies. The agency has established basic standards for 
clinical image reviewers, including that they be interpreting 
physicians, and will review and monitor each accreditation body's 
performance of this critical function. However, FDA believes the actual 
evaluation of clinical images should remain the role of the 
accreditation body. At its January 1997 meeting, NMQAAC discussed the 
issue of using the MQSA inspectors for clinical image review. They 
concluded, and the agency agrees, that inspectors do not have, nor can 
reasonably be given, the training and expertise required to perform 
clinical image review.
    f. Image management (Sec. 900.4(c)(6))
    Section 900.4(c)(6) requires the accreditation body to establish a 
tracking system for clinical images to ensure their security and return 
to the facility within 60 days.
    (Comment 148). One comment stated that the requirement to return 
all clinical images within 60 days was too restrictive, because 60 days 
would not be adequate if a third review were required. This comment 
recommended 90 days. Another comment stated that the turnaround time 
for accreditation body image review was already too long, and that such 
delays limited a facility's opportunity to submit a second set of 
improved images within the review time cycle. A third comment stated 
that films should be returned to facilities in 45 to 60 days.
    With respect to this matter, FDA has had to balance the needs of 
the facility against those of the accreditation body. Using the 
experience gained under the interim regulations, the agency concludes 
that the 60-day period is appropriate.
    (Comment 149). One comment stated that Sec. 900.4(c)(6)(ii) should 
clearly state that the accreditation body is obligated to inform only 
the facility of any abnormalities found on clinical images submitted to 
the accreditation body which had been interpreted by the facility as 
negative. The comment explained that this obligation should not extend 
to informing either patients or referring physicians.
    FDA believes it is imperative that patients and referring 
physicians be notified of any suspicious abnormality detected during 
the clinical image review process. However, the agency has concluded 
that only the facility that performed the examination has access to the 
necessary patient and referring physician information to allow proper 
notification of the affected individuals. FDA has modified the 
regulation accordingly.
    (Comment 150). One comment stated that proposed Sec. 900.4(c)(6) 
implied that mammography reports would be sent to the accreditation 
body with the films. The comment asserted that requiring facilities to 
submit reports would raise concerns about patient confidentiality and 
establish an additional and new requirement for facilities.
    FDA agrees with this comment and the regulation has been amended to 
delete the reference to mammography reports.
    g. Unsatisfactory image quality (Sec. 900.4(c)(7))
    Section 900.4(c)(7) describes the accreditation body's 
responsibility when it determines that clinical images from a facility 
that it accredits are unsatisfactory.
    (Comment 151). One comment stated that the accreditation body has 
no direct authority to ``take appropriate action'' if corrective 
measures to address poor clinical image quality are not implemented by 
the facility.
    Section 900.4(c)(7) has been modified from the proposal to address 
this comment. As discussed previously, FDA agrees that responsibility 
for enforcing compliance with the MQSA requirements rests primarily 
with FDA. Accreditation bodies, however, can and are expected to take 
action to revoke or suspend the accreditation of facilities that do not 
comply with standards established by the accreditation body, which 
include producing high quality clinical images. This section has been 
changed to state that the accreditation body is responsible for 
notifying the facility of the nature of the problem and its possible 
causes. The requirements that have been deleted, to monitor the 
progress of the facility and to take appropriate action if corrections 
are not made, are inherent in the accreditation process and have been 
stated previously in Sec. 900.4(a)(1)(ii).
5. Phantom Image Review (Sec. 900.4(d))
    The review of phantom images is an important part of the evaluation 
of a facility for accreditation. The production and evaluation of 
phantom images is also an important part of the medical physicist 
survey, of the facility inspection, and of the facility's quality 
assurance program. However, Sec. 900.4(d) covers only the requirements 
that the accreditation body must meet to ensure that its phantom image 
reviews are performed accurately, in a timely fashion, and without 
bias.
    a. General comments on phantom image review
    (Comment 152). Two comments stated that phantom image review by the 
accreditation body is unnecessary because it is performed twice a year, 
once by the medical physicists during annual physics surveys and again 
by inspectors during yearly inspections.
    FDA notes that, as with clinical image review, the phantom image 
review performed during the accreditation process and the reviews 
performed at other times have different purposes. The words ``for 
accreditation and reaccreditation'' have been added to the title of 
Sec. 900.4(d) to clarify the purpose of the phantom image review in 
this section. During the accreditation process, phantom images are 
reviewed by the accreditation body to determine if the facility is 
producing adequate quality images to permit its accreditation or 
reaccreditation. The phantom image reviews conducted during a medical 
physicist survey, an inspection, or as part of the facility quality 
assurance program are intended to provide some assurance that the 
facility continues to produce adequate quality images during the 3-year 
interval between accreditations. Because of these different objectives, 
the agency believes that the multiple phantom image evaluations are not 
redundant.
    b. Phantom image reviewers (Sec. 900.4(d)(5))
    This paragraph discussed the requirements for and the procedures to 
be followed by the phantom image reviewers.
    (Comment 153). Two comments stated that FDA did not provide any 
specific qualifications and training requirements for the accreditation 
body phantom image reviewers in the proposed rule. One comment wanted 
further clarification of these qualifications and the other expressed 
concern that accreditation bodies may have widely different criteria 
for phantom image reviewers. A few comments recommended that only 
medical physicists be considered qualified for phantom image review, 
but another comment expressly opposed that limitation. Six comments 
supported Sec. 900.4(d)(5)(I) as written.
    FDA has stated in Sec. 900.4(d)(5)(I) that the accreditation bodies 
must ensure that their phantom image reviewers meet the requirements 
specified in Sec. 900.12(a)(3) for medical physicists or alternative 
requirements established by the accreditation bodies and approved by 
FDA in accordance with Sec. 900.3(d). The agency believes that this 
provides sufficient guidance to accreditation bodies with respect to 
qualifications and training requirements, while permitting flexibility 
to accommodate different

[[Page 55883]]

circumstances among the accreditation bodies.
    FDA does not agree with the comments that only medical physicists 
should be allowed to perform phantom image review, although any medical 
physicist who met either the requirements in Sec. 900.12(a)(3) or FDA-
approved alternative requirements could serve in this capacity. The key 
criteria are that the individuals doing the phantom image review be 
adequately trained in the review process and have sufficient 
educational background to understand the concepts involved. The ability 
to carry out the full range of the responsibilities of the medical 
physicists under the MQSA is not required. The agency believes, 
therefore, with proper training and experience, individuals other than 
medical physicists can become qualified to evaluate phantom images.
     All phantom image reviewers, whether or not they are medical 
physicists, must comply with the additional requirements, established 
by FDA in Sec. 900.4(d)(5)(ii) and (iii), to be trained in the review 
process, to document scoring, and to provide feedback to facilities on 
improvement measures. If the accreditation bodies develop their own 
alternative or additional requirements for phantom image reviewers, FDA 
will ensure consistency among the accreditation bodies through its 
oversight program.
    (Comment 154). Eight comments wanted the agency to require phantom 
image review by at least two reviewers. One comment stated that all 
facilities should use the same phantom and the same scoring procedure.
    The agency has no evidence to suggest that double reviews are 
necessary for adequate evaluation and did not make this a regulatory 
requirement. However, FDA notes that it is currently the common 
practice of all accreditation bodies to have all failed phantom images 
evaluated by a second reviewer.
    FDA disagrees with the comment regarding the same phantom and 
scoring procedures for all facilities. The agency wants to refrain from 
specifying either a phantom type or scoring methodology in order not to 
inhibit future advancements in phantom evaluation procedures. In 
addition, experience has shown that phantom type and scoring 
methodology is generally consistent from facility to facility even 
without a regulatory requirement. FDA will continue to monitor the 
situation and will ensure that any different phantoms or scoring 
methodology that may be in use will not compromise the minimum 
standards currently approved.
    (Comment 155). Two comments on this provision expressed concerns 
about possible conflicts of interest for reviewers. FDA has addressed 
this issue in Sec. 900.4(a)(4), which was discussed previously.
    c. Image management (Sec. 900.4(d)(6))
    As proposed, this paragraph required the return of the phantom 
image to the facility that produced it.
    (Comment 156). Three comments stated that returning phantom images 
increases costs without benefit. Another stated that retaining the 
images would allow the accreditation body to compare past and current 
images to assess possible changes in a facility's QC program.
    FDA believes that phantom images that result in a failure of 
accreditation should be returned to the facility in order to illustrate 
the accreditation body's assessment of the nature of the problem and 
its possible causes. Such images can be a valuable learning tool for 
the facility as it seeks to correct its problems. To minimize costs, 
however, FDA has revised this paragraph to require the accreditation 
body to return only those images that cause a failure.
    d. Notification measures for unsatisfactory image quality 
(Sec. 900.4(d)(7))
    As proposed, this paragraph described a variety of actions that the 
accreditation body should take if it finds a facility's phantom image 
is of insufficient quality to permit accreditation of the facility. The 
provision has been revised, as has the parallel provision for clinical 
image review discussed above, to focus on the accreditation body's 
obligation to notify the facility of the nature of the problem 
identified and of possible solutions.
    (Comment 157). Six comments supported Sec. 900.4(d)(7) as proposed. 
The comments stated that this requirement provides assistance to the 
facility and promotes timely correction of problems. Two comments 
expressed concern that the accreditation bodies could ``close'' a 
facility on the basis of inadequate quality of phantom images even if 
the facility had been producing high quality clinical films. The 
comments explained that this could happen because of the subjective 
nature of phantom image review and the fact that problematic phantom 
images are unavoidable, in spite of adequate care.
    Because Sec. 900.4(d)(7) requires the accreditation body to notify 
the facility of the nature of the problem and its possible causes, FDA 
does not believe the review process will prevent accreditation of a 
facility that is able and willing to devote resources to improvements 
in this area. It is the policy of the approved accreditation bodies to 
offer facilities at least two chances to improve the quality of failed 
images to the satisfactory level. If the facility uses the information 
provided by the accreditation body on the possible causes of the 
problem to guide corrective actions, the agency believes that a 
facility producing high quality work, as the comments described, should 
be able to achieve the minimum phantom image quality required by the 
accreditation body.
    (Comment 158). One comment stated that the accreditation body has 
no direct authority to ``take appropriate action'' if corrective 
measures are not implemented.
    As discussed previously in connection with clinical image review, 
nothing in the proposed provision would require the accreditation body 
to act beyond its authority, which includes a responsibility to deny, 
suspend, or revoke accreditation of facilities that do not achieve the 
accreditation body's standards. However, the agency has reworded the 
provision to focus on its primary purpose, which is to ensure that 
facilities who fail the phantom image review are informed of the 
causes.
6. Reports of Mammography Equipment Evaluations, Surveys, and QC 
(Sec. 900.4(e))
    This paragraph describes the reports on the evaluations of their 
equipment that the accreditation body must require from each facility, 
the reporting schedule, and the responsibility of the accreditation 
body to review the reports and to use them in accreditation decisions.
    (Comment 159). Several comments expressed varying viewpoints on the 
need for submission of this information and who should evaluate it. One 
comment stated that it is redundant for facilities to have to submit 
information about equipment to the accreditation body because each 
facility is inspected annually, and also may receive an onsite visit 
from an accreditation body. This would result in three reviews 
annually, which would be unnecessary and burdensome to both the 
facility and the accreditation body. Three other comments also stated 
the position that the accreditation body should be the sole evaluator 
of the annual physicist survey. One of the three also contended that 
the inspector, unless a qualified mammography medical physicist, is not 
qualified to review these reports. This comment suggested that the 
inspection review be eliminated and that the accreditation body be 
required to send a statement to FDA confirming that the report was 
received and reviewed.

[[Page 55884]]

    On the other hand, one comment urged that both the accreditation 
body and the inspector continue to review the physicist survey reports. 
Another comment stated that, if duplicate review is not deemed cost 
effective, then the inspector should review the survey rather than the 
accreditation body. These two comments agreed that it is imperative 
that the facilities both read the report and correct any deficiencies 
that could lead to noncompliance or degradation of images, but 
expressed a concern that facilities would not do so unless both the 
accreditation body and the inspector required such actions. A third 
comment agreed that the inspector should not just accept the 
accreditation body's review of the facility survey. Valuable 
information would be lost if the inspector does not review the survey.
    FDA believes that having both the accreditation body and the 
inspector review the physicist's report is consistent with the MQSA's 
reliance on review by different entities and is a benefit to the public 
health, especially during these early years of the MQSA program. The 
two checks are different in nature. The accreditation bodies make a 
complete assessment of such surveys as they are reported annually. 
Inspectors, on the other hand, do not evaluate the surveys the same 
way. Instead, inspectors check for completeness and to determine if the 
facility has implemented necessary corrections identified in the 
survey. Typically, the submission of surveys to the accreditation 
bodies and the occurrence of inspections are not coincident. Having the 
inspectors do an independent check may draw attention sooner to an 
incomplete survey or a problem found by the survey that has not yet 
been corrected.
    (Comment 160). One comment asked how five facilities became 
accredited without physicist reports.
    FDA and the accreditation bodies are unaware of any facilities that 
have been accredited without physicist reports. Because the facilities 
for which such accreditation was alleged were not identified in the 
comment, it is not possible to respond further.
    (Comment 161). Nine comments argued, that as proposed, 
Sec. 900.4(e)(2)(i) would lead to facilities changing from a 12-month 
cycle to a 14-month cycle for the medical physicist survey.
    FDA agrees with these comments and the section has been changed 
accordingly.
7. Onsite Visits to Facilities and Random Clinical Image Reviews 
(Sec. 900.4(f))
    The MQSA requires that accreditation bodies make a ``sufficient 
number'' of onsite visits to the facilities they accredit ``to allow a 
reasonable estimate of the performance'' of the body (42 U.S.C. 
263b(e)(4)(A)). The statute also requires the accreditation body to 
conduct random reviews of clinical images from the facilities it 
accredits, in addition to the clinical image reviews required for 
accreditation (42 U.S.C. 263b(e)(1)(B)). Section 900.4(f) implements 
these requirements.
    a. General comments on onsite visits
    (Comment 162). One comment questioned the cost-effectiveness of 
requiring accreditation bodies to prepare three copies of a summary 
report describing all facility assessments conducted during that year. 
The comment asserted that FDA could review this information during the 
annual oversight inspection of the accreditation body.
    Under the statute, FDA is required to evaluate the performance of 
each accreditation body. The summary of onsite visits provides valuable 
information on which to base such evaluations. FDA, therefore, retained 
the requirement that three copies of the summary be included in the 
accreditation body's annual report to FDA. Multiple copies will allow 
simultaneous review by multiple reviewers and, in the event that some 
of the materials are difficult to reproduce, will help ensure 
uniformity and readability of the materials.
    b. Onsite visits (Sec. 900.4(f)(1))
    (Comment 163). Three comments agreed with the need for onsite 
visits, while two comments stated that the visits were unnecessary. Two 
comments recommended that the onsite visit be combined with the annual 
inspection, while two other comments stated that the onsite visit 
should not be construed as a substitute for, or be conducted during, 
the annual inspection. One comment stated that the onsite visit process 
does not serve as a check of the accreditation body's quality assurance 
process.
    FDA reiterates that the requirement for onsite visits by the 
accreditation bodies is established by the statute (42 U.S.C. 
263b(e)(4)). The purpose of such visits is to provide a mechanism by 
which accreditation bodies can ensure facility compliance with quality 
standards and monitor their own performance of accreditation functions. 
The accreditation body will be able to compare the consistency of 
results from visits to information obtained through other accreditation 
body functions. These onsite visits by the accreditation bodies are 
different from and are intended to be complementary to the annual 
inspection of every certified facility performed by FDA or State 
inspectors. Combining the two evaluations into one review would likely 
undermine the effectiveness of both visits and inspections. This issue 
was discussed with NMQAAC and the agency's position was supported by a 
consensus of the committee.
    (Comment 164). One comment recommended a prior notice of 5 days for 
onsite visits so as not to disrupt patient care. FDA believes that 
accreditation bodies will need flexibility in scheduling onsite visits. 
In some cases, particularly if an accreditation body has serious 
concerns about a facility's ability to meet quality standards, 
significant advance notice would not be appropriate. In general, for 
facilities selected randomly for onsite visits, FDA encourages 
accreditation bodies to work with facilities to schedule visits that 
minimize patient inconvenience and disruption to facility operations. 
This has been the general practice of all accreditation bodies.
    c. Sample size (Sec. 900.4(f)(1)(I))
    Section 900.4(f)(1)(I) requires accreditation bodies to select some 
facilities for onsite visits on a random basis and select other 
facilities based on specific reasons for concern about those 
facilities, such as a previous history of noncompliance with quality 
standards. In general, each accreditation body will have to visit 
annually at least 5 percent of the facilities it accredits, up to a 
maximum of 50 facilities, but no less than 5. The number could exceed 
50 if many facilities need to be visited because of previously 
identified concerns.
    (Comment 165). Two comments agreed with Sec. 900.4(f)(1)(I) as 
proposed. However, 14 comments recommended that the maximum of 50 
facilities be raised to a higher number. Reasons given for the increase 
included a belief that 50 is not statistically significant for a large 
accreditation body. Two comments wanted the number raised because they 
had ``seen too many certified facilities with questionable 
compliance.'' One comment stated that a national accreditation body 
should visit at least one facility from each State or region.
    The agency disagrees with raising the number of onsite visits. FDA 
has discussed with NMQAAC and the accreditation bodies the issue of the 
number of onsite visits that an accreditation body can reasonably 
perform. There was general agreement among NMQAAC and the accreditation 
bodies that the regulation should not be changed. The agency has had to 
balance

[[Page 55885]]

the benefits of accreditation body onsite visits against its monetary 
cost. Requiring more than 5 percent or 50 facilities could 
significantly increase the cost of accreditation and potentially reduce 
the number of accredited facilities and access to mammography without 
commensurate benefit.
    d. Visit plan (Sec. 900.4(f)(1)(ii))
    Section 900.4(f)(1)(ii) establishes baseline standards for the 
conduct and content of the onsite visits.
    (Comment 166). Four comments, including a consensus of NMQAAC, 
stated that the composition and qualifications of onsite visit teams 
should be specified. One of the comments recommended that the team be 
comprised of a qualified active clinical image reviewer, a phantom 
image reviewer, and an accreditation body staff member.
    The agency believes that the accreditation body is in the best 
position to define the onsite visit team. This gives the accreditation 
body the flexibility to tailor the team to the specific needs of the 
facility, thereby reducing costs while maintaining quality.
    (Comment 167). One comment believed that the decision to review 
clinical images and the selection of images should be made at the 
discretion of the accreditation body at the time of the visit. It 
stated that, if the facility has proper quality assurance procedures in 
place, it may not be necessary to review the clinical images. FDA 
disagrees. The agency believes that clinical image review is one of the 
most important aspects of the entire MQSA program and should be a part 
of every accreditation body onsite visit.
    (Comment 168). Two comments, including a consensus of NMQAAC, 
recommended that Sec. 900.4(f)(1)(ii)(D) be amended to require the 
accreditation body to ``verify the presence'' of the facility's medical 
outcomes audit system during an onsite visit, rather than ``review'' 
the system; requiring a review implies that the visit team is 
evaluating the audit against an agreed upon standard rather than 
verifying that a system is in place.
    FDA agrees and has modified this section accordingly.
    e. Clinical image review for random sample of facilities 
(Sec. 900.4(f)(2))
    This paragraph establishes the requirements for the clinical image 
review for a random sample of facilities.
    (Comment 169). Sixteen comments stated that there appears to be a 
contradiction in the preamble to the proposed regulations because 
remarks in one section questioned the effectiveness of random clinical 
image review, but another section stated that random visits for 
facilities are effective.
    FDA believes that the comments are comparing the agency's views of 
two different processes. The agency believes that random clinical image 
review is a useful tool in the evaluation of facilities and 
accreditation bodies. However, the agency stated in the proposal's 
preamble (61 FR 14890) that random clinical image review would not be 
an effective use of accreditation body resources if applied to all 
facilities. Random onsite visits to a limited number of facilities 
represent a different tool to evaluate facilities and accreditation 
bodies and, as stated in the preamble to the proposal, are effective in 
this context.
    (Comment 170). One comment stated that the goals of random clinical 
image review should be clearly determined prior to establishing minimum 
quality standards.
    As previously stated, the purpose of random clinical image review 
is to serve as an indicator of the quality of mammography performed at 
facilities, a measure of the performance of the accreditation body, and 
a method to assure the public that facilities continue to produce high 
quality images during the intervals between reaccreditation reviews. In 
this context, FDA believes that it is important that the accreditation 
bodies be given the flexibility to develop a process for random 
clinical image review that is best suited to meet their needs and those 
of their accredited facilities. However, the agency notes that 
Sec. 900.3(b)(3)(iii) requires a prospective accreditation body, as 
part of its application, to give FDA a description of its procedures 
for performing random clinical image review. In addition, the agency 
will monitor the use of random clinical image review as part of its 
oversight responsibilities.
    Eight comments stated that the sample size for random clinical 
image review in proposed Sec. 900.4(f)(2)(I) should be increased. Two 
of the comments recommended that all facilities undergo random clinical 
image review in each 3-year period. One of these comments stated that 
this is required by the statute.
    FDA addressed this issue in the preamble to the proposed rule and 
believes its interpretation of the statute is reasonable. FDA's 
proposal changed the interim rule, which required random clinical image 
review at every accredited facility, to a requirement that the 
accreditation body select a sample of facilities for random clinical 
image review. The change in the sampling requirement was based on FDA's 
experience under the interim regulations. The agency believes that 
annual random clinical image review for every facility, in addition to 
the clinical image reviews required for initial accreditation and 
reaccreditation, is not an effective use of accreditation body 
resources. FDA does agree that, after more data are accumulated, the 3 
percent sample in the proposal may prove to be too low. The agency, 
therefore, has revised the provision to state that at least 3 percent 
of the facilities be sampled annually, to allow the agency more 
flexibility to modify the sample size if information obtained in the 
future justifies such a modification.
    Section 900.4(f)(2)(ii) has also been revised from the proposal to 
clarify that reviewers performing random clinical image review shall 
evaluate the same film attributes used in accreditation and 
reaccreditation clinical image review.
    (Comment 171). One comment stated that randomly selected clinical 
images should not be evaluated with the same stringent requirements as 
those used for evaluating the ``best'' clinical images submitted for 
initial accreditation or reaccreditation.
     As previously stated, FDA will require the accreditation body to 
evaluate the same attributes in the random clinical image review as are 
evaluated in the accreditation and reaccreditation clinical image 
review. As previously explained, the agency believes that accreditation 
bodies will have to adjust their scoring and pass-fail criteria to take 
into account that, due to the selection process, these examinations may 
not be representative of the best images a facility can produce. Such 
adjustments are appropriate and are permitted under the final 
regulations.
    Section 900.4(f)(2)(iv) has been added to the regulations to 
clarify that the process for selection of images for random clinical 
image review may differ from the process for selection of images for 
accreditation and reaccreditation clinical image review.
    (Comment 172). Two comments noted that different accreditation 
bodies already have instituted different selection criteria for their 
random clinical image review. One comment suggested that the review 
should be a combination of random (selected by the inspector) and 
nonrandom (selected by the facility) studies.
    FDA recognizes that, under the interim regulations, each 
accreditation body has developed its own process for random clinical 
image review. Each is designed to best serve the needs of the 
accreditation body and its accredited facilities. The agency believes 
this

[[Page 55886]]

flexibility encourages efficient and effective review and has not 
changed the requirement. FDA believes that the selection of a 
combination of random and nonrandom studies would complicate the review 
process without a corresponding benefit. FDA is working with all of the 
accreditation bodies to further refine and improve their procedures and 
programs and will continue to do so. As noted previously, although each 
accreditation body can devise its own process for random clinical image 
review, that process must be reviewed and approved by FDA.
8. Consumer compliant mechanism (Sec. 900.4(g))
    This paragraph describes the responsibilities of the accreditation 
bodies to ensure that serious consumer complaints are adequately 
addressed.
    (Comment 173). The comments received were very similar to those 
received on Sec. 900.12(h), which outlines the responsibilities of the 
facilities in this area. The comments on both of these paragraphs are 
discussed in section III.L.8 of this document in connection with 
Sec. 900.12(h).
9. Reporting and recordkeeping (Sec. 900.4(h))
    No comments were received on this paragraph, which describes the 
mechanisms by which the accreditation bodies provide information to 
FDA.
    Consequently, this section was codified with only minor editorial 
changes.
10. Fees (Sec. 900.4(I))
    This paragraph outlines the requirements that must be met by 
accreditation bodies to ensure that the accreditation fees are 
reasonable.
    (Comment 174). Eight comments claimed that any fees are 
unreasonable, particularly for small practices, while another comment 
requested that multi-unit facilities be charged a higher fee.
    The MQSA clearly intended that the accreditation process be 
supported through facility fees and that the agency be assigned the 
task of ensuring that such fees are reasonable (42 U.S.C. 
263b(e)(1)(B)(iii)). FDA could not prohibit fees even if another source 
of funding were available. In response to the last comment, the agency 
notes that accreditation bodies can and do charge higher fees to multi-
unit facilities.

G. Evaluation (Sec. 900.5)

    This section states that FDA will evaluate the performance of each 
accreditation body annually, as required under the MQSA, and briefly 
outlines information that will be reviewed as part of the evaluation.
    (Comment 175). One comment urged FDA to establish standard 
evaluation criteria and procedures to apply to the review of all 
accreditation bodies prior to establishing final regulations.
    FDA agrees with this comment. Different accreditation bodies have 
different operational circumstances, e.g., geographic area and 
facilities served. Consequently, with FDA approval, they may have 
somewhat different programs. However, despite program differences, all 
accreditation bodies have to comply with the regulations governing 
accreditation body activities. Therefore, FDA has developed standard 
evaluation criteria that are being used to evaluate all accreditation 
bodies.

H. Withdrawal of Approval (Sec. 900.6)

    This section outlines the enforcement actions available to FDA, 
including withdrawal of approval, if the agency determines that an 
approved accreditation body has not remained in substantial compliance 
with the requirements.
    (Comment 176). One comment stated that ``major accreditation 
functions,'' upon which FDA could base a decision to withdraw an 
accreditation body approval, should be clearly identified. Another 
asked how FDA would verify that an accreditation body, whose approval 
had been withdrawn, had notified all of its facilities. Two other 
comments protested elimination of the mandatory schedule for 
accreditation bodies to submit corrective action plans for minor 
deficiencies.
    Based upon its history of regulating accreditation body activities 
under the interim regulations, FDA believes that withdrawal of approval 
of an accreditation body would be rare and, in any case, would follow 
notice of problems and attempts to bring the body into full compliance. 
Should such a withdrawal occur, however, FDA would closely monitor the 
entire process of closing down the accreditation body operations, 
including the required notification of facilities.
    FDA finds no basis for imposing mandatory schedules for correction 
of minor accreditation body deficiencies. Since approval of the first 
accreditation body in 1994, FDA has maintained a close working 
relationship with all the MQSA accreditation bodies. Accreditation body 
operational activities that might have been categorized as ``minor 
deficiencies'' have been resolved quickly and satisfactorily through 
direct communication with the accreditation bodies, rendering specific 
mandatory time limits for all such corrections unnecessary. The 
regulation continues to provide FDA with authority to specify a time 
period for any particular corrective action.

I. Hearings (Sec. 900.7)

    This section describes the rights of accreditation bodies and 
facilities to hearings challenging adverse actions.
    (Comment 177). Only one comment was received and it supported this 
section as written. Consequently, this section was codified with only 
minor editorial changes.

J. Applicability (Sec. 900.10)

    This section of the proposal stated that the provisions of subpart 
B (which includes the facility quality standards) apply to all 
facilities under the jurisdiction of the United States that provide 
mammography services, except for those of the Department of Veterans 
Affairs (VA).
    No comments were received directly on this section, although 
several comments on other sections questioned the exclusion of the 
facilities of VA. FDA notes that the wording of this section, including 
the exclusion, is based directly on the statute; the agency is unable 
to make any modifications (42 U.S.C. 263b(a)(3)(A)). However, VA is 
presently developing, under a separate legislative mandate, a program 
to ensure mammography quality equivalent to that required by the MQSA.

K. Requirements for Certification (Sec. 900.11)

    This section establishes the requirement that mammography 
facilities must have an FDA certificate in order to operate lawfully 
and provides details on how to make application for a certificate and 
the time period during which the certificate may be effective. Only 
some of the provisions of this section drew comments. Discussion of 
these comments follows.
1. General (Sec. 900.11(a))
    This paragraph requires mammography facilities to have certificates 
issued by FDA to operate lawfully. To obtain a certificate, facilities 
are required to meet the quality standards in Sec. 900.12 and to be 
accredited by an approved accreditation body or other entity designated 
by FDA.
    (Comment 178). One comment noted that FDA proposed to add that a 
facility may be accredited by an ``* * * other entity as designated by 
the FDA,'' that FDA claims to be concerned that at some time a facility 
may not have access to an accreditation body, and therefore an 
alternative accreditation body may be necessary for facilities to 
operate lawfully. The comment argued that there is no statutory basis 
for FDA to

[[Page 55887]]

appoint another entity and questioned under what circumstances a 
facility might not have access to an accreditation body. The comment 
closed by stating that, unless an urgent need for this provision can be 
clearly defined with limitations in its scope, it should be deleted 
from Sec. 900.11 and elsewhere in the regulation.
    The Secretary has discretion under the statute, both with respect 
to approving private nonprofit organizations and States as 
accreditation bodies and with respect to prescribing proof of 
accreditation. While the probability that facilities may not have 
access to an accreditation body is at present remote, there are neither 
guarantees nor requirements that any particular accreditation body will 
continue to serve in that capacity indefinitely. If one or more of the 
currently approved accreditation bodies were to become unable or 
unwilling to serve in that capacity, the agency wants provisions in 
place that will allow an alternative accreditation authority to be 
designated in order to ensure continuity and availability of quality 
mammography. Nothing in the statute precludes FDA from providing for 
this eventuality in its regulations or from designating other 
accreditation routes if that should ever become necessary to protect 
the public health.
    (Comment 179). One comment stated that facility certification 
should allow interpreting physicians to work outside of the certified 
facility. The comment interpreted the proposal to treat an offsite 
reading room the same as an offsite mammography clinic and maintained 
that requiring the offsite reading room to be certified is burdensome 
and unnecessary.
    FDA does not, at this time, intend to require separate 
certification of partial providers, such as an interpreting physician 
with an offsite reading room. The definition of a facility in 
Sec. 900.2(q) includes partial providers, and FDA recognizes that there 
may be future advantages to separately certifying partial providers of 
mammography services. For example, it may be advantageous for a 
radiological practice with one or more interpreting physicians to be 
certified as a facility. By doing so, the practice's interpreting 
physicians could interpret mammograms from any other certified facility 
without those other facilities having to demonstrate the qualifications 
of the interpreting physician. At the present time, however, policies 
and procedures have not been established for accreditation and 
certification of partial providers. Consequently, as is the case under 
the interim regulations, an interpreting physician interpreting 
mammograms at a remote site will be included under the certificates of 
the mammography facility for which he or she interprets mammographic 
images. The physician will have to provide information to those 
facilities demonstrating that the requirements regarding his or her 
qualifications and any other applicable MQSA standards are met.
2. Applications (for Certificates and Provisional Certificates) 
(Sec. 900.11(b)(2))
    FDA has amended the language in Sec. 900.11(b)(1)(ii), (b)(2)(ii), 
and (b)(3)(iii) from ``will'' to ``may'' in order to parallel the 
statutory language that gives the agency discretion with respect to the 
issuance of certificates, provisional certificates, and extensions of 
provisional certificates to practice mammography. Although the agency 
has relied on accreditation body determinations in making decisions 
about whether to issue certificates, and intends to continue to do so, 
there may be situations in which FDA has additional information not 
available to the accreditation body or when the agency has reason to 
disagree with the accreditation body's evaluation of the facility as 
likely to perform quality mammography. In those circumstances, the 
agency retains discretion to deny a certificate even if the facility 
has become accredited. A new provision has been added at Sec. 900.16 to 
implement the agency's statutory authority to deny certification to an 
accredited facility and to set forth the appeal procedures available to 
such facilities. In general, this paragraph requires that new 
facilities apply for accreditation through an approved accreditation 
body. Once a facility's application is accepted by the accreditation 
body, FDA may issue a provisional certificate that will allow the 
facility to perform mammography for not longer than 6 months in order 
to obtain the clinical images necessary for accreditation. A 
provisional certificate may not be renewed, but a facility may apply 
for a one time 90-day extension of the provisional certificate under 
certain circumstances.
    (Comment 180). One comment suggested extending the 6-month 
provisional certification period for facilities that failed to be 
accredited, and a second comment stated that a facility should make 
substantial changes before being granted a second provisional 
certificate. A third comment recommended that FDA provide for renewal 
of provisional certificates at the discretion of FDA because some 
facilities may not complete accreditation, through no fault of their 
own, and may not qualify for a 90-day extension. A fourth comment 
recommended that provisional certification should be limited to one 
time only and described the 90-day extension as generous, allowing 
facilities a 9-month period in which to achieve full compliance.
     In accordance with the MQSA, provisional certificates may only be 
extended for facilities that can demonstrate that access to mammography 
would be significantly reduced in the geographic area served by the 
facility, and only if the facility reports the steps that will be taken 
to qualify the facility for certification. In response to the first 
comment, therefore, FDA notes that there is no statutory provision for 
either an additional extension or the issuance of a second provisional 
certificate to the same facility.
    The agency recognizes the dilemma noted in the comment concerning 
facilities that have been unable, perhaps for reasons beyond their 
control, to complete accreditation within the time period. The final 
regulations provide for reinstatement of certain facilities that failed 
accreditation or failed to complete the process during the first 6 
months as new facilities. To qualify for reinstatement, the facility 
must submit and complete a corrective action plan developed to ensure 
correction of any deficiencies that led to failure. That corrective 
plan must be approved by the accreditation body and completed by the 
facility before the facility can be reinstated. On reinstatement, the 
facility is treated as a new facility, and issued a new provisional 
certificate that will allow it to produce mammograms for the clinical 
image review, which must be passed to obtain a 3-year accreditation and 
certification term.
    FDA understands the concern of those comments that suggested 
facilities should not be given additional time or a second chance to 
establish that they are capable of doing quality work. The agency has 
had to weigh those concerns against competing concerns for access and 
the statutory emphasis on bringing facilities into compliance rather 
than putting them out of business. FDA believes that its reinstatement 
policy strikes the proper balance.
    (Comment 181). Two comments agreed with Sec. 900.11 as proposed. 
Another stated that a better definition is required to differentiate 
between those facilities that fail the second film review and are later 
reinstated, and those that fail and submit a new application under the 
pretense of being a new facility.
    FDA and the accreditation bodies recognize the risk that might be 
created if a facility that failed accreditation is

[[Page 55888]]

issued a second provisional certificate under such pretense. FDA has 
instituted a variety of measures under the interim regulations to avoid 
such occurances, including close communication among accreditation 
bodies, between accreditation bodies and FDA, and a policy that each 
facility provide a history of previous accreditation activities with 
its application. The facility history requirement has been codified in 
the final regulation to require all applicant facilities to provide a 
complete history of prior accreditation activities, including a 
statement that all information and data submitted in the application is 
truthful and accurate, and that no material fact has been omitted. FDA 
expects to continue close communication among accreditation bodies and 
FDA to identify potential problems with this type of misrepresentation 
by facilities applying for accreditation.
    (Comment 182). One comment recommended that Sec. 900.11 be revised 
to include the MQSA provision that authorizes States to perform 
certification duties.
    The MQSA does provide that States may serve as certifying bodies 
(42 U.S.C. 263b(q)). However, this subject is beyond the scope of these 
proposed regulations. Preparations are under way to draft regulations 
that will govern State agencies that wish to become certifying bodies, 
and the public will have an opportunity to comment on future proposals.
3. Provisional Certification Extensions (Sec. 900.11(b)(3)(i))
    This paragraph describes the information a facility must submit to 
apply for a 90-day extension of its provisional certificate.
    (Comment 183). One comment noted that the statute requires FDA to 
evaluate requests for 90-day extensions but that this provision 
stipulates that a facility shall submit its evidence in support of 
extensions to its accreditation body. The comment asked if it is FDA's 
intent to transfer this authority to the accreditation bodies. If it is 
not FDA's intent to transfer this authority to the accreditation 
bodies, the comment requested that, ``* * * its accreditation body * * 
*'' be changed to ``the FDA.''
    The MQSA gives FDA the authority to evaluate and determine whether 
or not a facility qualifies for a 90-day extension of its provisional 
certificate, and FDA does not intend to transfer this authority to the 
accreditation bodies. However, the agency believes that it is in a 
better position to render valid decisions on requests for 90-day 
extensions if the accreditation body first reviews and makes a 
recommendation on the request in light of the accreditation body's 
detailed knowledge of the applicant and other facilities in the area. 
Therefore, the final regulation has been amended to clarify that the 
accreditation body will forward the facility's request for an 
extension, along with the accreditation body's recommendation. New 
Sec. 900.11(b)(3)(ii) requires accreditation bodies to forward both 
requests and their recommendations to FDA within 2 business days of 
receipt of the request.
4. Reinstatement Policy (Sec. 900.11(c))
    This paragraph contains the requirements and procedures for 
reinstatement of certification. Under this provision, FDA may permit a 
previously certified facility that has allowed its certificate to 
expire, that has been refused a renewal of its certificate by FDA, or 
that has had its certificate suspended or revoked by FDA, to apply to 
have the certificate reinstated.
    (Comment 184). Four comments expressed concern that reopening a 
facility whose accreditation has lapsed may be difficult and that 
reinstatement is necessary so that such facilities may qualify as new 
facilities and thereby qualify for issuance of provisional 
certificates.
    Reinstatement is the appropriate procedure for reopening a facility 
whose certification has lapsed. The MQSA only allows a provisional 
certificate to be issued to new facilities. As noted in section III.K.2 
of this document, any facility that seeks reinstatement under this 
provision of the regulations will have to provide sufficient 
information to its accreditation body to establish that any problems in 
meeting the MQSA standards have been corrected, and that circumstances 
are such that the facility may qualify as a new facility for purposes 
of reinstatement. The decision about whether to apply for reinstatement 
is one that each facility must make based on its own circumstances. If 
the costs associated with such application are too high for any 
particular facility, it will forgo providing mammography services. On 
the other hand, if a facility has determined that it can improve its 
practice sufficiently to warrant reinstatement, or that it wished to 
resume a practice it voluntarily closed, reinstatement will permit such 
facilities to qualify for provisional certification as new facilities, 
and produce the clinical images that are necessary for 3-year 
accreditation and certification.
5. Justification for Reinstatement (Sec. 900.11(c)(1)(iii))
    This paragraph requires a facility applying for reinstatement to 
justify its application.
    (Comment 185). A comment asked how this would cover a facility that 
allowed its certificate to expire for reasons other than failure to 
comply or qualify.
    FDA notes that a justification is required for all applications for 
reinstatement. A facility whose certificate has expired but that has 
had no deficiencies should submit a corrective action plan that 
explains the reasons for expiration and what it has done or will do to 
ensure that the facility meets the MQSA quality standards at the time 
of reinstatement.
6. Provisional Certificates to Reinstated Facilities (Sec. 900.11(c)(2) 
and (c)(3))
    (Comment 186). Four comments raised concerns about the 
appropriateness of issuing provisional certificates to reinstated 
facilities, as the agency had proposed.
    As a result of these comments, FDA has modified Sec. 900.11(c) to 
read, ``Reinstatement policy. A previously certified facility that has 
allowed its certificate to expire, that has been refused a renewal of 
its certificate by FDA, or that has had its certificate suspended or 
revoked by FDA, may apply to have the certificate reinstated so that 
the facility may be considered to be a new facility and thereby be 
eligible for a provisional certificate.'' This change is intended to 
make clear the need for a mechanism so that previously certified 
facilities that have instituted corrective actions or wish to resume 
services following voluntary cessation of mammography may be considered 
new facilities for purposes of issuing provision certificates as noted 
in section III.K.4 of this document. The agency has also changed the 
language of this provision from ``will'' to ``may'' in 
Sec. 900.11(i)(2) to indicate that the agency retains discretion to 
accept facilities for reinstatement.
7. The 2-Year Waiting Period (Sec. 900.11(c)(4))
    As proposed, this provision stated that if a facility's certificate 
is revoked, the facility may not be reinstated for 2 years if owned or 
operated by any person who owned or operated the facility at the time 
of revocation. Proposed Sec. 900.11(c)(4) did not accurately reflect 
the MQSA requirement because it imposed the 2-year waiting period on 
facilities rather than on persons. The MQSA requires a 2-year waiting 
period before persons who own or operate a mammography facility at the 
time an act is committed that results in revocation of the facility's 
certificate may again own or operate a mammography facility (42 U.S.C. 
263b(I)(3)).

[[Page 55889]]

    Section 900.11(c)(4), therefore, has been changed to read, ``If a 
facility's certificate was revoked on the basis of an act described in 
42 U.S.C. 263b(I)(1), no person who owned or operated that facility at 
the time the act occurred may own or operate a mammography facility 
within 2 years of the date of revocation.''
    (Comment 187). More than 40 comments expressed concern about how 
FDA would apply revocation and about the 2-year waiting period, which 
many comments suggested was excessive.
    These and related comments to Sec. 900.13 suggest an unwarranted 
expectation that suspension and revocation of certificates will be 
common practice in the event of noncompliance with the regulations. As 
noted above, the 2-year waiting period is mandated by the MQSA in the 
event of revocation of a certificate. That timeframe is not subject to 
modification by the agency. However, after more than 2 years of 
enforcement of the MQSA, FDA has not revoked any certificates and has 
only suspended the certificate of one operating facility. This should 
alleviate concerns that this enforcement action is one FDA is likely to 
use frequently or without cause.
    The conditions under which FDA may suspend or revoke a certificate 
are set forth in Sec. 900.14. In most cases, a suspension would precede 
a revocation action. As explained in the preamble to the proposed rule 
(61 FR 14878), suspension of a certificate generally would occur only 
when all other efforts to bring a facility into compliance with the 
regulations have failed or if continued operation of a facility would 
present a serious risk to human health. Suspension allows a facility to 
complete corrective action under accreditation body and FDA monitoring, 
and subsequently to be reinstated if those corrections are adequate. 
FDA generally intends to revoke certificates only when corrective and 
voluntary measures have failed and the agency has clear evidence that a 
facility cannot or will not practice quality mammography, or in the 
event the facility made false statements to FDA.
    Unless other more serious events, as indicated above, necessitate 
otherwise, FDA will not revoke or suspend a certificate as a result of 
a finding that a facility is correcting, is willing to correct, or has 
corrected identified deficiencies. FDA's goal is to bring noncompliant 
facilities into compliance with the MQSA standards so that they can 
produce quality mammograms, rather than to close facilities. This goal 
reflects the intent of the drafters of the statute; the legislative 
history discussing the sanctions provisions, e.g., states that ``the 
first priority of the Secretary is to restore a mammography facility to 
compliance * * *'' S. Rept. 102-448, at 2 (1192).
    (Comment 188). Ten additional comments stated that this section is 
frightening to many radiologists and asked who decides when voluntary 
action or lesser sanctions have proven ineffective, and if any third 
party reviews agency decisions. FDA will determine when voluntary or 
lesser sanctions have proven ineffective. The decision to suspend or 
revoke a certificate, however, is subject to challenge by the facility 
which is entitled to an informal hearing under 21 CFR part 16, and 
ultimately subject to judicial review.

L. Quality Standards (Sec. 900.12)

1. Personnel (Sec. 900.12(a))
    This paragraph of the regulations establishes the training and 
experience requirements for physicians who interpret mammograms, 
radiologic technologists who perform mammography examinations, and 
medical physicists who have responsibility for periodically surveying 
the mammography equipment and overseeing the facility's equipment 
quality assurance program. The requirements include initial 
qualifications that must be met before an individual can begin 
independently providing mammography services to the facility and 
continuing qualifications that must be met on an ongoing basis. 
Facility recordkeeping requirements related to personnel are also 
discussed.
    The final regulations generally retain the same requirements as 
were outlined in the proposal. In response to comments, however, the 
amount of training or experience needed to satisfy particular 
requirements has been adjusted in several places. The final regulations 
also establish a ``grand parenting'' provision for radiologic 
technologists.
    a. General comments on personnel section
    (Comment 189). General comments submitted by the public to FDA on 
Sec. 900.12(a) offered contrasting views on the value of the personnel 
standards. One comment applauded the increased specificity of the 
proposal over the interim rules because the changes clarified what 
requirements the facility personnel had to meet. A second comment 
likewise noted that the requirements were ``well presented'' and 
clarified a number of issues. In contrast, a third comment stated that 
the more specific requirements made it harder for facilities to show 
that the requirements were met. A fourth comment found the requirements 
too prescriptive (but offered no suggestions on what could be deleted 
as unnecessary), but a fifth comment asked for even more specificity.
    This variety of opinion illustrates the difficulty of striking the 
proper balance between making regulatory requirements specific enough 
so that it is clearly understood what is required yet general enough to 
allow for appropriate flexibility. FDA believes that the variety of 
comments indicates that significant changes to the general approach 
taken by the proposal are not warranted. However, the question of the 
proper balance between specificity and flexibility was reconsidered in 
response to comments on particular requirements.
    (Comment 190). One general comment asked for clarification on who 
would be qualified to teach physicians, technologists, and physicists 
to use new technologies as they develop.
    FDA believes that the new definition of qualified instructor 
(Sec. 900.2(oo)), discussed earlier, provides an adequate means for 
identifying qualified instructors. Under this definition, 
representatives of the manufacturers who develop new technology, along 
with the physicians, technologists, and physicists who worked with the 
technology while it was in the investigational stage, would generally 
be accepted as qualified to be the initial instructors in the use of 
the new technology. This approach is consistent with the general 
practice in the teaching of medicine.
    (Comment 191). Several of the general comments on the personnel 
requirements were based on a misinterpretation of the proposed 
regulations or of the MQSA itself. Six identical comments argued for 
retaining the interim regulations, not because they opposed the 
proposed new requirements as such, but because they believed that the 
choice was between either the interim regulations or performance-based 
outcome measures, such as proficiency testing.
    As explained previously, while comments were requested on the 
concept of performance-based outcome requirements, new performance-
based requirements are not being proposed at this time.
    (Comment 192). Another comment mistakenly believed the regulations 
made investigational use of MRI unlawful but, in fact, MRI procedures 
are not within the scope of the MQSA (42 U.S.C. 263b(a)(6)). Similarly, 
two general comments recommended removing of this section entirely,

[[Page 55890]]

reasoning that because FDA does not impose training or experience 
requirements on users of other medical devices, there was ``no possible 
justification'' for mammography being treated differently.
    In fact, however, Congress has directed that mammography be treated 
differently and required the government to establish personnel 
standards (42 U.S.C. 263b(f)(1)(C), (D), and (E)). The MQSA embodies 
Congress's determination that such standards would help ensure that 
mammography services are provided only by those qualified to do so.
    b. Comments on interpreting physicians (Sec. 900.12(a)(1))
    The final regulations for interpreting physicians establish initial 
professional, educational, and training qualifications, as well as 
requirements for continuing experience and education. Although neither 
a national standard nor a continuing performance competency test for 
mammography interpretation currently exists, the requirements of 
Sec. 900.12(a)(1) for interpreting physicians will provide baseline 
standards to help ensure the reliability and accuracy of interpretation 
of mammograms for women throughout the country.
    The final regulations are generally the same as those proposed. In 
response to comments, however, some new provisions have been added and 
several others were revised as follows: (1) Sixty rather than 40 hours 
of documented medical education in mammography must be Category I; (2) 
a new section was added to clarify the use of CME obtained by teaching 
medical education courses; (3) the mechanism to document continuing 
experience and education requirements has been revised to reduce the 
administrative burden on facilities; (4) additional pathways for 
physicians who need to reestablish their qualifications have been 
added; and (5) the initial qualifications have also been modified to 
clarify the conditions for ``grand parenting'' of interpreting 
physicians and the initial experience requirement for some residents. 
These changes from the proposal will be discussed below in connection 
with the appropriate provisions.
    (Comment 193). Over 100 comments stated that only radiologists 
should be permitted to work as interpreting physicians.
    After considering these comments, FDA continues to believe that 
this additional limit would not be in the interest of public health. 
Currently, there are some physicians, not formally trained as 
radiologists, who have met the requirements of the interim regulations 
and are competently interpreting mammograms. Therefore, FDA believes 
that it would be unnecessarily restrictive to limit interpreting 
physicians to radiologists. By requiring all physicians wishing to 
interpret mammograms to meet the same baseline quality standards of 
training, experience, and continuing education, the goal of ensuring 
quality mammography can be achieved without arbitrary restrictions 
relating to the specialty of the particular physician.
    (Comment 194). One comment suggested that interpreting physicians 
who practice at more than one facility should be required to provide 
proof of credentials and qualifications only one time, rather than 
providing this material for each facility with which the physician is 
affiliated.
    FDA disagrees for a number of reasons. First, the MQSA requires 
mammography facilities to meet certain requirements, including 
establishing that its personnel are qualified under the statute. 
Because it is the facility that is responsible and will be inspected, 
it is necessary for that facility to have documentation for all the 
interpreting physicians who work there. In addition, while several of 
the initial personnel requirements do not change over time, some, such 
as medical licenses, are time limited and need to be updated. 
Similarly, if the continuing experience and education requirements are 
not updated by the personnel, the facility can be cited for violations 
of the MQSA.
    (Comment 195). One comment stated that interpreting physicians 
should be required to pass an annual, documented visual acuity test. In 
response to this suggestion, FDA notes that while visual acuity is 
important, there are no standards as to what would constitute 
acceptable visual acuity. The agency does not believe it is necessary 
to become involved in those details of physician fitness that are 
better handled by licensing authorities.
    (Comment 196). Two comments stated that training in ultrasound 
should be required for interpreting physicians as part of the 
accreditation program.
    Under the MQSA, FDA's authority to regulate mammography is limited 
to radiography of the breast. Therefore, requirements related to 
ultrasound have not been included in personnel or other facility 
standards.
    (Comment 197). Two comments supported FDA's position that all 
physicians reading mammograms should be required to meet the same 
training standards. The comments stated that this is particularly 
important with regard to locum tenens and that facilities may need to 
be reminded that their locum tenens should provide all appropriate 
documentation prior to beginning independent interpretation.
    FDA agrees that all personnel are required to meet the same 
standards regardless of whether they work full or part-time and 
facilities must make sure that all the personnel at their facility meet 
the necessary requirements.
    The quality standards for interpreting physicians are divided into 
four sections: Initial qualifications; continuing experience and 
education; exemptions; and reestablishing qualifications.
    Under Sec. 900.12(a)(1)(i), the first qualification for an 
interpreting physician is a State license to practice medicine.
    (Comment 198). Over 50 comments recommended that the proposal be 
changed to state that all interpreting physicians should be licensed in 
``the'' State in which they practice.
    FDA does not believe the proposed regulation should be amended. 
Although Sec. 900.12(a)(1)(I)(A) requires the interpreting physician to 
have ``a'' State license to practice medicine, in the vast majority of 
cases, State laws require a physician to be licensed in ``the'' State 
in which he or she is practicing. If the State in which the mammography 
facility is located is different from the State that issued the 
license, a physician may have to meet additional State requirements in 
order to practice medicine lawfully at that facility. With respect to 
physicians practicing in Federal facilities, a valid State license from 
any State is sufficient. However, the Federal employee would be unable 
to practice outside the Federal facility unless the physician also 
fulfilled the requirements of that State for the practice of medicine.
    Under Sec. 900.12(a)(1)(I)(B), the second initial qualification for 
interpreting physicians is board certification or 3 months of 
documented formal training in interpreting mammograms. The training is 
to include radiation physics (including radiation physics specific to 
mammography), radiation effects, and radiation protection.
    (Comment 199). Over 80 comments stated that all interpreting 
physicians should be board certified radiologists. The comments stated 
that being board certified establishes that the person reading the 
mammogram understands all the basic principles of physics and breast 
anatomy and that this would ensure the most accurate readings. In 
contrast, four comments disagreed with the use of specialty board 
certification as a measure of qualification. These comments generally 
argued that requiring specialty board certification will adversely 
affect patient access to

[[Page 55891]]

medical services. These comments also stated that many individuals 
certified by the ABR did not receive formal training in current 
mammography techniques because their training predated the development 
of modern mammography standards. One comment stated that individuals 
certified by ABR before 1989 were not examined in mammography 
techniques as part of their board certification process and that the 
oral examination process of ABR certification is highly subjective and 
influenced by personality and demeanor. The comment also claimed that 
ABR has awarded board certification through the ``Class A'' rule, in 
which favorite candidates were certified without any examination 
process, and that ABR does not adhere to ``due process'' by using 
subjective oral examinations to certify candidates.
    In response to criticism of board certification as fulfillment of 
an initial quality standard, FDA notes that the statute specifically 
recognizes board certification as one of the mechanisms for meeting a 
portion of the interpreting physician requirements (42 U.S.C. 
263b(f)(1)(D)(I)(I)). In addition, the agency continues to believe that 
board certification is a valid indication of overall competency. FDA 
recognizes that some earlier board examinations may not have included 
testing in mammography. FDA also recognizes that board certification 
that includes mammography testing cannot ensure the accuracy of 
outcomes in clinical mammography practices; no training or 
certification program can guarantee proficiency in all cases. However, 
board certification is evidence that the physician is knowledgeable in 
the basics of diagnostic radiology and can serve as a foundation for 
the additional requirements specific to mammography that interpreting 
physicians must meet under FDA's regulations. The ``Class A'' rule 
referenced in the comments was used in the mid 1930's during the 
startup phase of the ABR in order to certify those outstanding 
physicians who were experienced in the field of radiology. This rule 
has not been used in over 50 years and, since 1940, all candidates have 
had to take examinations. FDA does not believe that the ``Class A'' 
rule has a significant bearing on the radiologists practicing today. 
While FDA does agree that there is some subjectivity in all tests, the 
agency is satisfied that the accepted boards represent a valid means of 
determining general competency. FDA disagrees with the assertion that 
the boards do not adhere to due process. Formal appeals processes are 
available to those candidates who wish to dispute a board decision. For 
all these reasons, FDA believes that board certification must remain an 
acceptable way to meet a portion of the initial qualifications for 
mammography personnel.
    In response to comments that questioned the validity of permitting 
physicians who are not board certified to practice mammography, FDA 
notes that Congress directed FDA to establish an alternative pathway to 
board certification (42 U.S.C. 263b(f)(1)(D)(I)(II)). FDA believes that 
the 3 months of documented formal training will ensure that all 
physicians interpreting mammograms have received an adequate amount of 
instruction.
    (Comment 200). Several comments, including a consensus of NMQAAC, 
stated that the 3-month training alternative was appropriate, but that 
the topics, number of hours for each topic, and the qualifications for 
those teaching these topics should be specified. NMQAAC and others 
believed that this training should be limited to that obtained in a 
radiology residency program. Some, including members of NMQAAC, said 
that the physics training should only be obtained from a medical 
physicist. One comment suggested that FDA require a minimum of 200 
hours of physics training.
    After considering all the comments, FDA has concluded that 
specifying the precise number of hours spent on each topic would be too 
prescriptive and would curtail the ability of training programs to 
individualize their curricula. FDA also believes that restricting 
training to radiology residency programs or, in the case of physics, to 
training by a medical physicist, would limit adequate training 
opportunities. FDA's experience under the interim regulations has led 
the agency to conclude that adequate training opportunities are also 
available to physicians who are not involved in radiology residency 
programs.
    (Comment 201). Several comments stated that FDA should notify the 
certifying boards, residency programs, facilities, and personnel of the 
new requirements so that sufficient training and proper documentation 
are given to all physicians. One comment suggested phasing in the 3-
month training requirement to allow program directors the time needed 
to adjust their curricula. One comment stated that physicians should be 
made aware that it is their responsibility to keep track of training 
and continuing education.
    FDA agrees with the general points being made by these comments. 
The agency has and continues to provide the appropriate boards, 
programs, facilities, and personnel with the information they need to 
meet and document the requirements of the MQSA. Programs should have an 
adequate amount of time to adapt to the new requirements, which will 
not go into effect until 18 months after publication of this rule.
    (Comment 202). Several comments suggested that 2 months of 
documented formal training in the interpretation of mammography, the 
current requirement under the interim regulations, is more than 
sufficient and that the increase to 3 months was excessive. One comment 
proposed that the 3 months be reduced to 2 months for those who have 
been reading mammograms consistently for 5 years or more. Another 
comment suggested that individuals who have qualified under the interim 
regulations should not be required to reapply or provide further 
documentation beyond that which was previously submitted to FDA.
    FDA has received advice from NMQAAC, AHCPR, and others that 2 
months of training for new physicians is insufficient to cover all the 
required topics. AHCPR has advocated 4 months of training. FDA believes 
that the increase from 2 to 3 months is appropriate and can be 
instituted by residency and other training programs without undue 
burden. As explained below, interpreting physicians who began 
independent interpretation under the interim regulations are considered 
to have met the initial qualifications under the final regulations. 
There will be no need for them to reapply or supply additional 
documentation to FDA. Also, because the 3-month requirement applies 
only to new interpreting physicians, anyone with the suggested 5 years 
of consistent experience should have qualified previously under the 
interim regulations.
    (Comment 203). One comment stated that any physician who is not a 
radiologist should be required to demonstrate competency in mammography 
through an examination, in addition to the training requirements.
    FDA declines to accept this suggestion. The agency has concluded, 
as discussed earlier, that adequate training programs can ensure that 
an interpreting physician has skills to practice mammography, 
regardless of his or her initial specialty. In addition, FDA agrees 
with the many public comments the agency received concerning the 
difficulties associated with physician competency testing as a 
qualifying method. At the present time, a suitable test to judge the 
competency of interpreting physicians does not exist. This may become 
an option in the

[[Page 55892]]

future, but until it does, training requirements appear to offer the 
most satisfactory method of establishing quality standards.
    (Comment 204). One comment recommended that all interpreting 
physicians be urged to meet exactly the same criteria without regard to 
board status. The comment suggested that the original alternative 
pathway established by the interim regulations, 2 months of documented 
training in interpreting mammograms, 40 hours of CME in mammography, 
and 15 hours of Category I CME per 3-year period, should be required 
for all interpreting physicians, even those who are board certified.
    In response to this comment, FDA notes that the MQSA establishes an 
alternative rather than a cumulative requirement in this matter. While 
FDA always encourages individuals to strive for excellence by exceeding 
the requirements, either of the two pathways (board certification or 3 
months training) will be sufficient training to meet this portion of 
the initial requirement. All interpreting physicians, including those 
who are board certified, are required to comply with the initial and 
CME requirements. This has been true under the interim regulations and 
will continue to apply under the final regulations.
    The third initial requirement for interpreting physicians, 
Sec. 900.12(a)(1)(i)(C), is 60 hours of documented medical education in 
mammography, including instruction in the interpretation of mammograms 
and education in basic breast anatomy, pathology, physiology, technical 
aspects of mammography, and quality assurance and QC. Unlike the 
proposed rule, the final regulation requires that all 60 of these 
credits be Category I CME. At least 15 of these 60 Category I CME hours 
must have been acquired within the 3 years immediately prior to 
qualifying as an interpreting physician. Hours spent in residency 
specifically devoted to mammography will be considered as equivalent to 
Category I CME and will be accepted if documented in writing by an 
appropriate representative of the training institution. The specific 
mammographic modality training requirement that was included in the 
proposed rule (61 FR 14907) has been deleted from this part of the 
final regulations because it is duplicated in Sec. 900.12(a)(ii)(C).
    (Comment 205). Several comments agreed with Sec. 900.12(a)(1)(I)(C) 
as originally proposed, while others, including NMQAAC, maintained that 
all 60 hours of credit should be Category I in order to provide 
consistency in the quality of the training. Several comments 
recommended that the number of hours spent in each subject be 
specified. Many comments said that the 40 hours already required by the 
interim regulations are sufficient and that raising the number to 60 
would have a negative impact on cost and the availability of 
mammography services. Several stated that Category II credit is just as 
educational as Category I and should be allowed. One comment questioned 
the value of CME requirements generally, stating that most of what is 
said at conferences and courses is repetitive.
    FDA disagrees with the comment questioning the usefulness of CME. 
The agency believes that 60 hours of training is in keeping with 
current trends in training and the emergence of new technologies. 
Because this expanded requirement will apply only to new interpreting 
physicians and time spent in residency specifically devoted to 
mammography will be accepted toward meeting this requirement, FDA does 
not believe that the number of hours required will have a negative 
impact on availability of services. FDA has been persuaded by the 
comments and its experience under the interim regulations that all 60 
hours should be Category I. Category I CME credits are generally those 
that offer more formal training and provide a solid basis for the 
ongoing maintenance and growth of the interpretive skills of the 
physician. While Category II hours may be useful, the variability of 
such education and the difficulty in documenting such training 
convinced FDA to strengthen the requirement by making all 60 hours 
Category I. FDA has not specified the number of hours required to be 
spent in each subject because the agency believes that this would be 
too restrictive and would limit the ability of physicians and programs 
to individualize training.
    (Comment 206). Three comments recommended that FDA clarify that the 
persons providing this training be in active practice and individually 
fulfill these qualifications.
    FDA disagrees with these comments. It is not necessary for all of 
the persons providing the training to meet the qualifications of 
interpreting physicians. For example, those teaching basic breast 
anatomy, pathology, or physiology do not have to be interpreting 
physicians to provide expert instruction in those subjects.
    (Comment 207). One comment asserted that 40 or 60 hours of training 
does not qualify someone to read a mammogram.
    In response to this comment and others that questioned the clinical 
value of any particular requirement, FDA agrees that 60 hours of 
training alone does not qualify a physician to read a mammogram. 
However, this is only one of a series of requirements; the combination 
of requirements relating to training, experience, and continuing 
education is intended to provide assurance that those interpreting 
mammograms meet baseline quality standards.
    The final initial qualification relates to experience reading 
mammograms. Section 900.12(a)(1)(I)(D) requires the qualifying 
physician to interpret or multi-read at least 240 mammographic 
examinations within the 6 months immediately prior to the date that the 
physician qualifies as an interpreting physician. This interpretation 
or multi-reading shall be under the direct supervision of an 
interpreting physician. The intent of this requirement is to 
demonstrate recent supervised experience before the physician begins to 
interpret mammograms independently. Although the language has been 
clarified, this requirement is essentially unchanged from the proposal.
    (Comment 208). Several comments misinterpreted the proposed 
requirement to mean that interpreting physicians would have to 
interpret 240 studies under direct supervision any time he or she 
changed facilities.
    That interpretation is incorrect. This is an initial requirement 
for the individual prior to beginning practice as a new interpreting 
physician and is independent of the number of facilities at which the 
physician works.
    (Comment 209). Two comments suggested that the requirement to 
interpret 240 mammograms under direct supervision should be revised to 
be 240 within the last 2 years of training prior to qualification as an 
interpreting physician. The comments stated that the requirement of 240 
mammograms in the last 6 months of training is virtually impossible for 
any residency program with more than 6 residents in any postgraduate 
year.
    FDA agrees. Both the proposal and the final rule include a 
provision that allows residents to meet this requirement in the last 2 
years of their radiology residency programs if they become 
appropriately board certified at the ``first allowable time.'' See 
discussion of Sec. 900.12(a)(1)(iii)(B) that follows.
    (Comment 210). One comment asked for clarification concerning the 
240 mammograms that a physician must interpret for initial training. 
The comment wanted to know if two

[[Page 55893]]

readings of a mammogram can be counted as two interpretations.
    Multi-reading, as defined in Sec. 900.2(ff), allows two or more 
physicians to read the same mammogram and each may count it as one 
interpretation. However, one physician may not read the same mammogram 
twice and count it as two separate interpretations.
    (Comment 211). Several comments stated that physicians should be 
given a document stating the number of mammograms read after completing 
residency training. This would assist the facility in making sure 
physician requirements are met.
    FDA agrees that this is a good idea and has and will continue to 
inform residency programs of the benefits of such a policy. However, 
FDA does not regulate residency programs and cannot require that such 
programs provide this documentation.
    (Comment 212). Several comments recommended that the supervised 
interpretation required for initial qualification be performed under 
someone qualified to teach interpretation. NMQAAC recommended that this 
training be obtained in a radiology residency program.
    While the majority of interpreting physicians will receive this 
training in their residency program, FDA believes that restricting such 
training to only those in radiology residency programs would 
unnecessarily limit the availability of adequate training 
opportunities. As previously discussed, FDA's experience under the 
interim regulations has led the agency to conclude that adequate 
training opportunities exist outside of radiology residency programs.
    Section 900.12(a)(1)(ii)(A) is the first of the requirements 
established to ensure that interpreting physicians, who have met 
initial requirements, maintain their qualifications as they practice 
mammography. Under this requirement, in order to continue to qualify 
under the MQSA rules, interpreting physicians are required to have 
interpreted or multi-read at least 960 mammographic studies in the 
previous 24 months. Although the wording has changed somewhat from the 
interim and the proposed final rules, there has not been a substantial 
change in this requirement. The proposal has been amended so that a 
total of 960 examinations have to be interpreted in the previous 24 
months instead of the previous formulation of an average of 40 
examinations per month over 24 months. This requirement continues to 
provide flexibility to physicians who find they need or want to 
interrupt their practice for periods of time for personal or 
professional reasons (e.g., maternity, illness, sabbaticals). The 
wording has also been revised to clarify that the 24 months can be 
measured in any of the following ways: From the date of the annual 
inspection of the facility at which the interpreting physician works; 
from the last day of the calendar quarter immediately preceding the 
annual inspection date; or from any date in between the two. These 
options will ease the paperwork burden on the facility and allow the 
facility to gather and monitor this information in a more efficient 
manner. For example, rather than tabulate daily or monthly totals, the 
facility may wish to tabulate this data only at the end of the quarter 
prior to the next expected annual inspection. FDA strongly recommends 
that facilities use the same tabulation method and the same option for 
determining the 24-month period for all of their personnel for 
simplicity and to help achieve consistency within the facility. 
However, this is not required.
    (Comment 213). Ten comments stated that diagnostic radiology 
graduates who pursue a fellowship in a field other than mammography 
face a difficult situation and will unnecessarily burden supervising 
physicians when they resume mammographic interpretation at the end of 
these fellowships. The comments stated that interpreting physicians who 
meet the requirements for 2 months training during residency and pass 
the certifying board exams have been adequately educated, and their 
interpretations do not need to be supervised when they resume reading 
mammograms.
    FDA disagrees and has received advice from many groups, including 
NMQAAC, that continuing experience is a necessary requirement to help 
ensure the accuracy of mammographic interpretation. FDA believes that 
it is in the best interest of the patient for physicians who have not 
interpreted the required number of studies in the previous 24 months to 
be supervised prior to independent interpretation. This requirement 
applies equally to radiology fellows who have been outside the practice 
of mammography as well as to interpreting physicians who stop 
practicing for a significant period of time.
    (Comment 214). FDA received 17 comments addressing the issue of 
interpreting an average of 40 mammographic examinations per month. Of 
these, 7 agreed with the proposal or recommended a higher number of 
examinations, while 10 asserted that the requirement was unnecessary, 
or that the number was too high and would adversely effect low volume 
or rural facilities.
    FDA believes that all women, including those in rural areas, are 
entitled to the same quality of care. The agency cannot support lower 
standards for particular facilities. The agency also believes that it 
will not be difficult for most physicians to meet this continuing 
qualification, even for those in rural areas. The agency also wants to 
clarify that this is a physician requirement, not a facility 
requirement. Interpreting physicians who provide services to low volume 
facilities can interpret films at more than one facility to attain the 
required number of examinations. Multi-reading of images previously 
interpreted by another physician is also accepted as a way of meeting 
this requirement. However, the physician may not count interpretation 
of the same mammogram more than once. Currently, under the interim 
regulations, multi-reading is being used successfully by some 
interpreting physicians to meet this requirement. For all of these 
reasons, the agency believes this requirement will not cause a 
mammography access problem.
    FDA recognizes that numbers alone cannot guarantee competency, but 
believes that the experience a radiologist accumulates through 
interpreting a certain minimum number of studies is a necessary aspect 
of the qualification process. In Sec. 900.12(f), FDA has issued 
requirements for the establishment and implementation of a medical 
outcomes audit for individual physicians. When used properly, this type 
of monitoring can further improve the reliability, clarity, and 
accuracy of interpretation of mammograms.
    (Comment 215). One comment stated that FDA should not set a maximum 
number of films that can be read by an interpreting physician.
    FDA agrees. There is nothing in the MQSA or the regulations that 
establishes such a limit.
    Section 900.12(a)(1)(ii)(B) requires interpreting physicians to 
further maintain their skills by teaching or completing at least 15 
Category I CME credits in mammography in the previous 36 months. This 
training must include at least six Category I continuing education 
credits in each mammographic modality used by the physician. As with 
the continuing experience requirement, FDA has modified the language of 
the proposal to allow facilities greater flexibility and efficiency in 
tabulating this data for interpreting physicians working at the 
facility.
    (Comment 216). Seventeen comments raised questions about CME in

[[Page 55894]]

technologies that do not fall within the scope of the MQSA, such as 
ultrasound or MRI. These comments asked whether 6 hours of CME in each 
of these breast imaging applications is required and, if not, can such 
continuing education in these technologies nevertheless be used to 
satisfy the CME requirements. Two comments suggested further 
clarification of what activities are acceptable as CME.
    Because these technologies are outside the scope of the MQSA, there 
is no requirement for a physician to have continuing education in them 
in order to qualify under the MQSA. CME in such technologies may, 
however, be applied to fulfill a portion of the continuing education 
requirement if that continuing education is likely to aid the physician 
in the understanding of mammographic breast cancer detection. CME in 
ultrasound and MRI of the breast would fall into this category and 
could be used to fulfill a portion of the continuing education 
requirement.
    (Comment 217). Several comments supported the requirement for 
interpreting physicians to obtain at least 15 Category I CME every 3 
years. Others asserted that there was no clear basis for the 
requirement. One comment stated that the interim rule requirements 
regarding completion of CME are unnecessarily bureaucratic because 
one's knowledge does not suddenly expire with an arbitrary deadline. 
Two comments maintained that the cost and number of man-hours required 
by these regulations is a serious burden, particularly considering that 
there is no scientific evidence that these efforts will result in 
improved medical care. Another comment indicated that training in each 
mammographic modality is already part of training programs and, for the 
vast majority of individuals, training is unnecessary because they have 
been providing services in these modalities for many years. This 
comment and others asserted that requirements for additional 
documentation of continuing education is unnecessarily burdensome for 
physicians who can demonstrate that they have completed an accredited 
program and have appropriate certification.
    FDA has been advised by NMQAAC and professional organizations, such 
as ACR, that continuing education is necessary in order to maintain 
skills in an ever changing field of medicine. The agency agrees and 
notes that the statute, 42 U.S.C. 263b(f)(1)(D)(ii), establishes a 
general requirement for continuing education. FDA has required that the 
credits be Category I CME in order to ensure that continuing education 
is more formal, can be documented, and contributes to the development 
of the professional skills of the physician. FDA believes that there 
are many avenues for obtaining this education and that the cost and 
man-hours required will not be overly burdensome on physicians. This 
requirement, as it relates to timeframes for monitoring compliance, has 
been modified from the proposal in a manner similar to that for 
continuing experience. This change will clarify that facilities need 
not update CME for physicians on a daily or monthly basis. FDA has 
evaluated many different scenarios for use as averaging periods and 
reviewed this particular issue with NMQAAC.
    (Comment 218). Several comments recommended that CME be averaged 
over a fixed 3-year period rather than on any given day. FDA notes that 
under a fixed 3-year period, physicians could acquire CME credits at 
the beginning of one period and at the end of the next, resulting in a 
span of almost 6 years in which the physician had not received any CME.
    FDA has concluded that the present floating 36-month period is more 
likely to contribute to quality mammography. A floating 36-month period 
eliminates the possibility that physicians will go for extended periods 
of time without continuing education. At the same time, it still 
permits physicians to devote their time to longer courses, when they 
are available, and to update their CME when the best opportunities for 
training arise, regardless of when that offering is made within the 36-
month period.
    (Comment 219). One comment recommended that interpreting physicians 
be tested every 2 years to keep up to date with all changes in the 
discipline.
    FDA believes that, at the present time, there is no adequate 
proficiency test to judge the continuing competency of interpreting 
physicians. For the foreseeable future, continuing experience and 
education requirements appear to offer the most satisfactory method for 
establishing compliance with these personnel standards.
    (Comment 220). One comment requested stricter control over 
acceptable ways for an interpreting physician to obtain continuing 
education units in mammography. The comment claimed that interpreting 
physicians who do not attend actual view box classes, but get their CME 
from a syllabus, have higher call back rates on films that they 
interpret. The comment recommended that all interpreting physicians be 
required to attend actual hands-on training seminars.
    FDA disagrees with this comment. After discussion with NMQAAC, the 
agency believes that limiting continuing education to hands-on training 
would greatly restrict the ability of many interpreting physicians to 
obtain such training, without providing a documented corresponding 
benefit. FDA believes that syllabi and other types of training can be 
as beneficial as hands-on training.
    (Comment 221). Several comments, including some from NMQAAC, 
indicated that a better definition of modality was needed. In order to 
reduce any confusion, the term ``modality'' has been changed to 
``mammographic modality'' to emphasize that the term does not refer to 
nonmammographic techniques, such as ultrasound or MRI, that may be used 
to examine the breast.
    Several comments stated that the requirement for six Category I CME 
credits in each mammographic modality is impractical and recommended 
that the continuing education qualification be left at 15 Category I 
credits in breast imaging, as required under the interim regulations. 
The comments went on to say that radiologists do more than just breast 
imaging and that, in any case, breast imaging courses do not list their 
credits by mammographic modality.
    FDA believes that the requirement for six Category I CME credits in 
each mammographic modality used by the interpreting physician is 
consistent with the goal of maintaining expertise. At the present time, 
there are only two mammographic modalities available, film screen and 
xeromammography. More than 99.5 percent of facilities are using only 
one mammographic modality, namely film screen. Currently, because there 
is only one mammographic modality generally used, this requirement 
would not create an additional burden for the vast majority of 
physicians. When digital mammography becomes available, those 
physicians using both film screen and digital modalities would have to 
acquire at least six category I CME credits in each of these 
mammographic modalities over a 3-year period. If three different 
mammographic modalities become available and all three were used by an 
interpreting physician, that physician would have to accumulate at 
least 18 Category I credits in the previous 36-month period, 6 in each 
mammographic modality. It is true that designation of CME credits in 
mammographic modalities other than film screen is not commonplace at 
the present time. However, as courses become available in digital 
mammography, the number of

[[Page 55895]]

hours devoted to the new mammographic modality can be documented by the 
course sponsors. In the meantime, keeping a copy of the program outline 
listing the lecture titles will serve as adequate documentation for the 
MQSA inspectors.
    Section 900.12(a)(1)(ii)(C) requires that, before using a new 
mammographic modality in his or her practice, the interpreting 
physician must have at least 8 hours of training with that mammographic 
modality.
    (Comment 222). Several comments, including those from NMQAAC, 
supported this requirement, while many others wanted additional 
clarification or stated that 8 hours was excessive because similar 
skills are used in all mammographic modalities. Several comments asked 
how this training could be obtained and documented in light of the fact 
that CME courses do not presently provide such training or give 
certificates in such detail.
    FDA believes that 8 hours of training in a new mammographic 
modality is an appropriate baseline. FDA agrees that there is overlap 
in the skills necessary to interpret studies done by different 
mammographic modalities. However, there are enough differences to 
justify this additional education. Before a physician begins to 
interpret images produced by a particular mammographic modality, the 
agency believes that the physician should have specific training in the 
interpretation of such images. Until new mammographic modalities become 
widely available, there may be a paucity of formal CME courses giving 
such instruction. FDA recognizes this and, therefore, has not required 
that this be Category I CME. This will allow other entities, such as 
equipment manufacturers, to supply the initial training. In this way, 
physicians and other personnel will be able to obtain the required 8 
hours of training from sources intimately associated with the new 
equipment they will be using. Formal category I CME courses will also 
be accepted. As mentioned previously, for those courses that do not 
list the CME by mammographic modality, the program outline can serve as 
documentation of how much time was spent in the new mammographic 
modality.
    (Comment 223). Many comments interpreted this requirement to mean 
that physicians must receive 8 hours of CME credit in xeromammography, 
which is now used very infrequently. These comments misinterpreted this 
requirement, which applies only when a physician begins using a 
mammographic modality in which he or she has not been previously 
trained.
    Because xeromammography is seldom used today, it would be extremely 
unlikely for an interpreting physician to begin using this mammographic 
modality for the first time. It would only be in this unlikely 
circumstance that the interpreting physician would have to obtain 8 
hours of xeromammographic training.
    (Comment 224). One comment suggested that, in addition to this 
requirement, the physician should also be required to interpret a 
specified number of mammograms from the new modality under the 
supervision of a qualified interpreting physician before independent 
interpretation.
    FDA does not support this additional requirement. While supervised 
interpretation might benefit interpreting physicians who begin using a 
new modality, the agency does not believe this qualification needs to 
be mandated for physicians who are already experienced in interpreting 
mammograms through another mammographic modality. Such a requirement 
could hinder the introduction of new mammographic modalities by raising 
the cost of initial training and significantly reducing access.
    With the concurrence of NMQAAC, Sec. 900.12(a)(1)(ii)(D) was added 
to the final regulations to clarify that CME earned by teaching a 
particular course could be counted only once towards the 15 credits for 
an interpreting physician under Sec. 900.12(a)(1)(ii)(B).
    Section 900.12(a)(1)(iii) establishes exemptions from certain 
personnel requirements for interpreting physicians in specific cases. 
Section 900.12(a)(1)(iii)(A) exempts physicians who qualified under the 
interim regulations from the new and additional initial requirements in 
Sec. 900.12(a)(1)(i): The additional month of training for physicians 
using the alternative pathway; the additional 20 hours of CME; and the 
requirement that 15 Category I CME credits must have been acquired in 
the 3 years immediately before qualifying as an interpreting 
physician.gi11(Comment 225). One comment opposed ``grand parenting'' of 
interpreting physicians who qualified under the interim regulations 
because of the ``minimal standards'' required under the interim 
regulations. Another comment agreed with the regulation as written.
    In order to ensure continuing and uninterrupted availability of 
mammographic services and because FDA's inspections over the past 2 
years do not demonstrate problems with these physicians, FDA is 
permitting those interpreting physicians who qualified under the 
interim regulations to continue to interpret mammograms, provided that 
they maintain the continuing experience and education requirements in 
Sec. 900.12(a)(1)(ii). As discussed in connection with other personnel 
requirements, the agency has determined that qualifying standards 
should be raised as new personnel qualify in the future because of 
increasingly complex and changing technologies. The agency has also 
concluded that the need for continued availability of services, 
fairness to practicing personnel, and the compliance record of 
facilities with the MQSA over the past years justify permitting 
personnel who qualified under the interim regulations to continue to 
practice. FDA believes the final rule strikes the proper balance among 
these considerations and is in the best interest of the public health.
    Section 900.12(a)(1)(iii)(B) establishes another exemption in 
response to concerns raised by members of NMQAAC and others that the 
initial experience requirement in Sec. 900.12(a)(1)(i)(D) may pose a 
problem for residency programs that schedule mammography rotations 
earlier than the final 6 months in the residency program. Instead of 
requiring the initial reading experience to be completed in the last 6 
months prior to initial qualification, this provision has been amended 
to permit some residents to satisfy the requirement by having 
interpreted at least 240 mammographic examinations under the direct 
supervision of an interpreting physician in any 6-month period during 
the last 2 years of the residency. This exemption is available only to 
those residents who successfully become board certified at the ``first 
allowable time,'' which means the earliest opportunity provided by an 
eligible certifying board. The physician who qualifies for this 
exemption would become responsible for fulfilling the continuing 
education and experience requirements of Sec. 900.12(a)(1)(ii) 
beginning on the date of that physician's board certification in 
diagnostic radiology, provided the other initial requirements are 
satisfied. If the physician does not become board certified at the 
first allowable time by the certifying board, the exemption does not 
apply and the physician must interpret 240 mammographic examinations 
under the direct supervision of an interpreting physician within a 
period of 6 months immediately prior to initial qualification as an 
interpreting physician.
    (Comment 226). Several comments said that this exemption was still 
too restrictive and recommended that the

[[Page 55896]]

requirement be expanded to allow reading at any time during the 
residency, rather than within the final 2 years. Some believed the 
requirement was too stringent because the exemption was available only 
to those residents who became board certified at the ``first allowable 
time.'' One comment asserted that residents who did not pass the boards 
at the first allowable time were no less qualified to perform 
mammography than the resident who successfully completed the boards, 
unless the physician failed the mammography section.
    After considering these comments, FDA has concluded that the final 
regulations provide sufficient flexibility. The exemption permits 
residents to interpret the required number of mammograms in any 6-month 
period during the last 2 years of their residency program, as long as 
they become board certified the first time they are eligible. This 
allows residency programs flexibility in scheduling their residents and 
prevents the scenario of having all senior residents doing their 
mammography rotation during the same 6-month period. FDA believes that 
mammography interpretations performed more than 2 years before 
completion of a residency program are not recent enough to qualify as 
initial experience, even in the situation where residents become board 
certified at the first allowable time. FDA expects that the 2-year time 
period will allow participants in virtually all residency programs to 
comply with the regulation. A baseline standard in general radiology 
would be ensured by the fact that residents qualifying for this 
exemption would have passed their certification boards, including the 
mammography section. Those residents not successfully completing their 
board certification at the first allowable time would not be eligible 
for this exemption.
    (Comment 227). Several comments stated that this exemption should 
be revised to allow an individual completing a radiology residency 
program and progressing on to a 1-year fellowship to qualify under 
Sec. 900.12(a)(1)(iii)(B).
    FDA disagrees and believes that meeting the initial requirements 
and qualifying for this exemption is independent of any additional 
training the individual may obtain. As discussed previously in 
connection with continuing experience requirements, FDA believes it is 
in the best interest of public health that interpreting physicians, 
including radiology fellows who have been outside the field of 
mammography, have relatively recent experience before beginning or 
resuming independent interpretation.
    Section 900.12(a)(1)(iv) provides a method for physicians to 
reestablish their qualifications as interpreting physicians in the 
event they do not maintain the continuing experience or education 
requirements. Section 900.12(a)(1)(iv)(A) requires the physician who 
has failed to meet the continuing experience requirement to interpret 
or multi-read either 240 mammographic examinations or enough 
mammographic examinations to bring the physician's total up to 960 for 
the prior 24 months, whichever is less. These interpretations shall be 
under the direct supervision of an interpreting physician and occur 
within the 6 months immediately prior to resuming independent 
interpretation. This section was modified from the original proposal to 
be consistent with policies that have been successfully implemented 
under the interim regulations to deal with physicians who need to 
reestablish their qualifications.
    Section 900.12(a)(1)(iv)(B) requires physicians who have not 
maintained the continuing education requirement to obtain a sufficient 
number of Category I CME credits in mammography to bring their total up 
to the required 15 credits in the previous 36 months. A physician who 
fails to maintain continuing experience or education requirements may 
not serve as an interpreting physician until he or she reestablishes 
those qualifications.
    (Comment 228). Two comments stated that there should be a penalty 
for physicians who do not meet the requirements in the appropriate 
timeframe.
    FDA believes that temporary disqualification from independent 
interpretation is the most effective and appropriate penalty in these 
situations. The purpose of the regulations is to ensure that personnel 
meet baseline standards. Under the final regulations, physicians who do 
not maintain the required number of interpretations or earn the 
necessary CME credits must cease independent interpretation of 
mammograms until such time as they complete a sufficient number of 
supervised interpretations or CME to meet the requirements. This is the 
best way to protect the public health. FDA disagrees with the comment 
that the physician should be penalized in some additional manner for 
not having maintained the continuing requirements.
    c. Radiologic technologists Sec. 900.12(a)(2)
    FDA's interim and final regulations for radiologic technologists 
performing mammography both seek to ensure that technologists: (1) 
Possess adequate general qualifications for performing radiologic 
examinations; (2) possess adequate specific qualifications for 
performing mammography examinations; and (3) maintain these 
qualifications over time. The changes from the interim regulations to 
the final regulations were primarily clarifications with some 
additional requirements to address concerns that became apparent as the 
interim regulations were implemented. In response to comments on the 
proposed rule, a number of changes have been made. A ``grand 
parenting'' provision has been added to qualify those technologists who 
met the interim requirements as fulfilling the initial training and 
experience requirements of the final regulations. The final regulations 
also relax the requirements that had been proposed for training 
specific to imaging patients with implants and reduce the number of 
supervised examinations that have to be performed as part of the 
initial requirements and to ``requalify'' in cases where the continuing 
experience requirement has not been met. The following changes are 
discussed in connection with the specific provisions.
     The general issue that drew the most comments was the question of 
whether a ``grand parenting'' clause should be added for presently 
practicing technologists.
    (Comment 229). Over 30 comments urged that technologists who met 
the qualification requirements of the interim regulations should be 
deemed to meet those of the final regulations. An additional six 
comments urged that technologists who have earned the advanced 
certificate in mammography from the American Registry of Radiologic 
Technologists (the ARRT(M)) should be accepted as meeting the final 
regulations.
    (Comment 230). Three comments recommended that either 40 hours of 
training or 20 hours and the ARRT(M) be the basis for grand parenting, 
while another comment urged that ``years of experience'' be the basis 
for grand parenting. Members of NMQAAC also recommended the addition of 
a limited grand parenting provision. Specifically, NMQAAC recommended 
limiting grand parenting to technologists who met the initial training 
requirements of the interim regulations by receiving 40 hours of 
training or earning the ARRT(M) (two of the several options that FDA 
had accepted under the interim regulations) and who had also performed 
at least 100 examinations.
    Many comments expressed concern that, without grand parenting of 
present

[[Page 55897]]

technologists, there would be no one qualified to practice under the 
final regulations without more training. The comments asserted that 
these training demands would be expensive, disrupt facility routine, 
and overwhelm the training resources available to technologists. Some 
of the comments further argued that there would be no one qualified to 
provide this training.
    The agency has been persuaded by the comments it received and the 
advice of NMQAAC that ``grand parenting'' provisions should be added to 
the technologist requirements. Under the final regulations 
technologists who have met the requirements of Sec. 900.12(a)(2) of the 
interim regulations by the effective date of the final regulations will 
be considered to have met the initial mammography training and 
experience requirements in the new regulations. Section 
900.12(a)(2)(ii) of the final regulations has been revised to reflect 
this. This change will achieve consistency with grand parenting 
provisions already existing for the other personnel groups. Although 
FDA believes that there are many technologists presently practicing who 
will meet the requirements of the final rule, this change will ensure 
that there will be an adequate number of qualified personnel to perform 
examinations and teach new technologists after the final regulations 
become effective.
    FDA did not extend this grand parenting to the continuing education 
and experience requirements of Sec. 900.12(a)(2)(iii) and (iv). Because 
these are ongoing requirements intended to ensure that technologists 
keep their skills sharp and their knowledge up-to-date, past 
qualifications can not be used to meet these requirements. Similarly, 
FDA did not include the general licensing or certification requirement 
established by Sec. 900.12(a)(2)(i) as a qualification that could be 
grand parented. Because the license or certificate has to be renewed on 
a periodic basis, fulfilling this requirement in the past cannot 
justify exempting technologists from the need for future renewal.
    On the other hand, FDA has declined to adopt the limitations on 
grand parenting proposed by NMQAAC. Under the interim regulations, FDA 
has accepted a number of ways for technologists to meet the initial 
mammography qualifications. Successful completion of 40 hours of 
training or the ARRT(M), the exclusive methods recommended by NMQAAC, 
are only two of these ways. Other ways technologists have been accepted 
as meeting the initial training requirement include obtaining a 
mammography certificate from the States of California, Arizona, and 
Nevada and successfully passing a comprehensive training course that is 
less than 40 hours in length but meets other rigorous criteria. Still 
other technologists have been accepted as qualified after a case-by-
case evaluation of their qualifications. FDA estimates that as many as 
several thousand technologists might be disqualified if the NMQAAC 
recommendation was accepted, creating a potentially serious impact on 
access to mammography, and individual hardship. FDA has no evidence to 
indicate that these technologists as a group are performing 
inadequately and, therefore, has retained them within the scope of the 
grand parenting provision.
    The requirements of Sec. 900.12(a)(2)(i) are intended to provide 
some assurance that the radiologic technologist is qualified to perform 
radiologic examinations.
    (Comment 231). Two comments supported this requirement as written, 
but others suggested various changes.
    Over 20 comments stated that technologists should be required to be 
licensed in ``the'' State in which they were practicing or, at least, 
if they met Sec. 900.12(a)(2)(i) through a State license, that it 
should be a license in ``the'' State of practice. A related comment 
suggested that FDA require technologists to meet State requirements 
that are as stringent as FDA's.
    FDA has not accepted the suggestions made by these comments for a 
number of reasons. First, the statute provides that technologists be 
given a choice between State licensure or certification by a 
professional body (42 U.S.C. 263b(f)(1)(C)(i)) and the law also 
requires that the license be from a State, not ``the'' State of 
practice. FDA can not limit the choices established by the statute and 
notes, in addition, that some States do not have technologist 
licensure. FDA also believes it to be beyond the authority conferred 
upon it by the MQSA to stipulate State licensure requirements.
    (Comment 232). One comment recommended that there should be 
national licensing of mammography technologists.
    FDA does not believe that the MQSA contemplated the establishment 
of a national licensing requirement to replace State standards and 
procedures. The statute's specific reference to State licensing as an 
alternative requirement supports this conclusion (42 U.S.C. 
263b(f)(1)(C)(i)(I)).
    (Comment 233). With respect to certification, one comment urged 
that the general certification be limited by regulation to that of 
ARRT.
    FDA agrees that ARRT general certification meets the requirements 
of Sec. 900.12(a)(2)(I) and, in fact, this is presently the only 
certification accepted by the agency for this purpose. However, as 
discussed in the proposal, FDA does not want to codify a list of 
eligible certifying bodies because that will restrict its ability to 
add or delete organizations in a timely manner (See 61 FR 14900).
    (Comment 234). Two comments suggested that FDA require 
certification bodies to establish a special mammography certification 
program based upon 6 months of training as an alternative to the 
general certification or licensing requirement.
    FDA does not believe that this is necessary. Certification bodies 
are free to establish alternative programs and expand existing ones and 
FDA will evaluate such programs on a case by case basis. However, the 
increased level of training contemplated by this suggestion may not 
justify the cost. Similarly, although FDA believes that the suggestion 
in another comment that technologists be required to watch radiologists 
read films 8 hours every 6 months to improve ``rapport'' may be useful 
training, FDA has no evidence that the expected benefit would warrant 
mandating such a requirement.
    The provisions of Sec. 900.12(a)(2)(ii) are intended to provide 
some assurance that technologists possess adequate qualifications 
specific to mammography before beginning to perform mammography 
examinations.
    (Comment 235). One issue related to these requirements drew several 
hundred comments, the largest number received on any part of the 
proposed regulations. This issue was the value of earning the ARRT(M) 
in meeting the specific mammography requirements for radiologic 
technologists. Unfortunately, over 80 percent of these comments, 
consisting primarily of multiple copies of 8 or 10 similar form 
letters, were based on a misunderstanding conveyed by an article in a 
journal that is widely distributed to mammography facilities. Many 
comments were based on an impression gained from this article that, 
because the ARRT(M) was not mentioned specifically in the regulations, 
it would have no weight in meeting the requirements. Some comments even 
indicated a belief that FDA would somehow ``take away'' the 
certification that the authors of the comments had worked so hard to 
obtain.
    The authors of these comments unfortunately did not understand that 
the ARRT(M) has been given great weight under the interim regulations 
as

[[Page 55898]]

evidence that the technologist is adequately qualified, even though it 
is not mentioned explicitly in those regulations. In fact, none of the 
large number of certificates or training programs that FDA has accepted 
to meet part or all of the personnel training requirements are 
mentioned in the interim regulations. FDA, moreover, stressed in the 
proposed regulations that the agency has ``recognized the value of 
training hours required for ARRT special certification'' and intends to 
continue to do so (61 FR 14094). Specific mention of a credential in 
the regulations is not necessary for acceptance and, as discussed 
earlier, the agency has concluded that codifying particular 
organizations or programs will hamper the agency's ability to evaluate 
training programs on a case-by-case basis and to make timely changes in 
the acceptance of such training (61 FR 14900, 14904).
    FDA regrets the distress this misunderstanding has caused many 
technologists and has contacted as many of the authors of these 
comments as possible to ease their concerns over the issue. The agency 
also has offered to work with the journal and the author of the article 
to ensure greater accuracy in future articles on the MQSA requirements. 
The journal has published the FDA correction of the article in an 
attempt to dispel this misunderstanding.
    (Comment 236). Some of the comments received about the ARRT(M) made 
specific suggestions as to what type of recognition it should receive. 
Nearly 150 comments expressed the opinion that the ARRT(M) should be 
required of all technologists doing mammography, while over 40 more 
stated that it should be required in association with other training.
    While FDA recognizes the great value of the ARRT(M) and intends to 
continue to accept it towards meeting the 40-hour requirement for 
radiologic technologists, the agency will not designate that particular 
certificate as a required or exclusive standard. FDA has no basis for 
establishing the ARRT(M) as the only way of demonstrating training in 
mammography. Furthermore, before a technologist can earn the ARRT(M), 
she or he must first earn general certification from the ARRT. The MQSA 
establishes that technologists have two alternative routes for general 
radiologic training: Either State licensure or certification by an 
approved professional group (42 U.S.C. 263b(f)(1)(C)(i)). If FDA were 
to require the ARRT(M), it would effectively eliminate the State 
licensure route to general qualification, in contradiction to the 
statuary provisions.
    (Comment 237). Over 50 comments urged that the ARRT(M) be accepted 
as an alternative to the 40 hours of training required by 
Sec. 900.12(a)(2)(ii). This also was the recommendation of NMQAAC 
members at the January 1997 meeting, although at earlier meetings 
NMQAAC had recommended that the ARRT(M) be accepted as equivalent to 
only 20 hours of training. One comment questioned the value of the 
ARRT(M), based on the opinion that the examination that must be passed 
to receive the ARRT(M) was not sufficiently specific to mammography.
    FDA will not accept the ARRT(M) in lieu of the 40 hours of training 
required by Sec. 900.12(a)(ii). The ARRT itself has recognized earning 
the ARRT(M) as equivalent to 24 hours of training. FDA does not have a 
basis for disagreeing with this evaluation by the sponsoring 
organization and, in most circumstances, intends to evaluate the 
ARRT(M) as equivalent to 24 training hours. FDA also notes that the 
performance of clinical examinations is a required component of the 40 
hours of training required under Sec. 900.12(a)(2)(ii) of the final 
rules. FDA has been informed by members of NMQAAC and others that 
technologists can and do pass the test for receiving the ARRT(M) 
without having performed any mammography examinations. For these 
reasons, although FDA did accept the ARRT(M) as meeting the interim 
regulation requirement to have training ``specific to mammography,'' 
and will continue to do so until the effective date of the final 
regulations, the ARRT(M) will not be considered equivalent to the final 
requirement of 40 hours of training, which must include the performance 
of examinations.
    (Comment 238). Over 100 comments urged that the ARRT(M) be accepted 
as meeting at least part of the 40-hour training requirement of 
Sec. 900.12(a)(2)(ii). Another 27 comments made suggestions for the 
number of hours for which it should be accepted, with the numbers 
varying from 5 to 30 hours.
    FDA agrees that the ARRT(M) is acceptable for meeting part of the 
training requirement. Also, as already noted, the agency intends to 
accept the ARRT's estimate of the amount of training represented by its 
approved programs, unless there is evidence, now or in the future, that 
such acceptance is not warranted. Thus, the ARRT(M) ordinarily will be 
accepted as meeting 24 hours of the 40-hour training requirement and 
the agency reiterates that the fact that the ARRT(M) is not 
specifically mentioned in the regulations does not preclude this 
acceptance.
    (Comment 239). A number of other comments addressed whether 40 
hours of training was an adequate and appropriate amount to provide 
reasonable assurance of quality mammography. Twenty comments stated 
that it was a reasonable amount. Three comments asserted that the 
amount of training was excessive or even that training in mammography 
was not needed. An additional comment was concerned about the impact of 
the requirement on small facilities.
    In response to these comments, the agency notes that training for 
radiologic technologists specific to mammography is required by the 
statute. The agency also notes that nearly all technologists who have 
met the interim regulations, whether at small or large facilities, have 
already obtained 40 hours of training or close to it without a 
noticeable adverse impact on the facilities. Some portion of these 
comments, and seven others, may have been based on the mistaken belief 
that the 40 hours was required to be in addition to any previous 
training in mammography. The grand parenting provision, which provides 
that meeting the interim regulations will qualify individuals as 
meeting the initial training requirements under the final regulations, 
should alleviate some of these concerns.
    On the other hand, 14 comments stated that 40 hours of training was 
inadequate. Several of these made suggestions for higher levels of 
training, ranging up to 480 hours and including the performance of 200 
examinations. The preponderance of the comments, however, seemed to 
support the figure of 40 hours of training. This amount was originally 
recommended, and is still supported, by NMQAAC. In the absence of any 
current evidence that 40 hours of training are insufficient, FDA 
believes that no change needs to be made in this number of hours.
    (Comment 240). A number of comments addressed instructor 
qualifications. Concerns mentioned earlier, namely, that there would be 
no qualified instructors, have been addressed in part by the grand 
parenting provision. Thirteen other comments asked for more 
clarification as to who would be a qualified instructor or suggested 
listing specific categories of individuals who would be qualified.
    FDA believes that the new definition of qualified instructor in 
Sec. 900.2(oo) will address these concerns. Because of the wide variety 
of individuals who have expertise to provide the various segments of 
the technologist training, the agency wrote this definition with

[[Page 55899]]

the goal of describing certain groups that can be identified as 
qualified at this time, while retaining the flexibility to accept other 
individuals on a case-by-case basis.
    (Comment 241). Three comments urged that the training be required 
to be Category A, but another comment said that such a requirement 
would make it difficult for a facility to find courses to qualify new 
technologists.
    NMQAAC also did not reach a consensus on this issue. Although FDA 
has decided to accept only Category I training as meeting the 
interpreting physician requirements, the agency does not believe that a 
similar step is needed in the technologist area. In contrast to the 
situation with physician Category I and II training, the distinction 
between Category A and B is based upon whether or not prior approval by 
a recognized group has been obtained, not on the type of training. 
Thus, the concerns that led the agency to restrict physician training 
to Category I do not apply in the technologist situation.
    Similarly, FDA does not believe that it is necessary to require the 
40 hours of training to be ``graduate'' training that is taken after 
the technologist meets the requirements of Sec. 900.12(a)(2)(i), as 
suggested by one comment. FDA is unaware of any reason to believe that 
the mammography training received as part of the technologist's basic 
training curriculum is unacceptable.
    (Comment 242). Four comments were critical of the concept of 
continuing education courses, stating that students ``sleep through 
them'' and that they are only ``money-makers'' for the training 
providers.
    While abuses of these types may exist, FDA believes that the great 
majority of training providers are sincerely interested in providing 
training that will improve medical care and that the great majority of 
students are equally interested in learning as much as possible from 
their training.
    (Comment 243). Another large group of comments addressed the 
specific requirements included in Sec. 900.12(a)(2)(ii). Nine comments 
suggested the addition of more subjects to those required to be 
included in the 40 hours of training. Specific suggestions included 
technical factors, film evaluation and critique, pathology, mammography 
of disabled women, and communication with patients. Three other 
comments supported the proposed inclusion of the topics of positioning 
and quality assurance.
    FDA agrees that the topics suggested, and probably many others, 
could be valuable components of technologist training. Some, in fact, 
are subsumed under the topics proposed and finalized under 
Sec. 900.12(a)(2)(ii)(A). However, the agency's intention was to limit 
this list in the regulation to only the subject areas most central to 
the quality performance of mammography examinations in order to 
maximize flexible and individualized training. FDA has added only 
imaging of patients with breast implants to the list of required 
topics, for reasons discussed below. The final regulation includes the 
words ``but not necessarily limited to'' to clarify that training in 
other areas also could be included in the 40 hours as long as the basic 
areas are covered. The agency intends to make additional information 
available on training programs and subjects that can satisfy this 
requirement.
    At its January 1997 meeting, NMQAAC reconsidered a recommendation 
it made earlier and advised that FDA amend the proposed regulations to 
require the initial experience requirement of Sec. 900.12(a)(2)(ii)(B) 
to be in addition to the 40 hours of training instead of part of the 
training, as was proposed. FDA did not receive any other comments 
making this recommendation. After considering the advice of NMQAAC, the 
agency has decided to retain the proposed requirement without 
amendment. FDA's experience in implementing the MQSA over the past 
years has not provided evidence that the significant increase in the 
training hours (approximately 50 percent over the proposal) that would 
result from NMQAAC's recommendation is warranted.
    (Comment 244). Several other comments asked for clarification about 
whether previous training could be counted towards the mammography 
requirement or expressed concern about current technologists having to 
repeat their training. As explained previously, under the grand 
parenting provision that has been added, radiologic technologists who 
have previously qualified under the interim regulations will be deemed 
to have met the initial personnel requirements and will not have to 
repeat training for that purpose.
    Section 900.12(a)(2)(ii)(B) requires that performance of clinical 
examinations under direct supervision of a qualified individual be part 
of the initial training. This requirement was intended to be parallel 
to the requirement that existed for interpreting physicians under the 
interim regulations and was continued for them in the final 
regulations.
    (Comment 245). Eight comments supported this provision, noting that 
competency comes about by combining didactic training with actual 
experience and that such a requirement has worked well in the State of 
Iowa for several years.
    A much larger number of comments opposed such a requirement. Eight 
of those opposing the requirement mistakenly believed that the 
supervision would have to be done by a radiologist and such supervision 
was not available in their situation.
    Supervision of radiologic technologist examinations by a physician 
is not required; the new definition of a qualified instructor 
(Sec. 900.2(oo)) should help correct this misunderstanding.
    (Comment 246). Twenty comments expressed concerns about having 
qualified supervision, especially in small and rural facilities. The 
new grand parenting provision that has been added to the final rule for 
radiologic technologists should solve this problem in areas where a 
shortage might have occurred.
    (Comment 247). Nineteen other comments raised concerns about 
requiring supervised mammography examinations that related to issues of 
cost, liability, and patient privacy.
    FDA notes that these are all issues that have been faced and 
successfully resolved by technologist schools nationwide in connection 
with the clinical training that they provide their students. FDA 
believes that they are manageable concerns and that any difficulties 
they raise are outweighed by the benefit of clinical training for 
radiologic technologists. The agency also notes that the addition of 
the grand parenting provision will limit this requirement to new 
technologists wishing to enter the field and that the number of 
examinations has been decreased, as discussed below.
    (Comment 248). Six comments took the position that practical 
training was not needed. Their authors apparently believed that 
technologists could learn to adequately perform mammography 
examinations with only classroom training.
    FDA disagrees. In view of the difficulty of performing adequate 
mammography examination, the agency believes that some clinical 
experience is vital for initial qualification.
    (Comment 249). A number of comments expressed conflicting views on 
the appropriate number of examinations that should be done as part of 
the initial training. Twenty-two of these comments expressed the 
opinion that 50 examinations was too many, due to cost or difficulty of 
completing that number, or because of a belief that fewer examinations 
would serve the same purpose. Ten comments,

[[Page 55900]]

however, suggested higher numbers, ranging up to 200 examinations.
    The question of the number of initial examinations was raised at 
the January 1997 NMQAAC meeting, but no recommendation was made on the 
issue. After considering these comments, FDA concluded that reducing 
the required number to 25 examinations would give the technologist 
adequate initial experience, while at the same time ease burdens 
relating to cost and availability of the training.
    (Comment 250). A relatively large number of comments were also 
received on the requirements proposed in Sec. 900.12(a)(2)(ii)(C). 
These comments focused primarily upon the proposal that all 
technologists doing mammography should receive at least 5 hours of 
training in the imaging of patients with breast implants as part of 
their 40 hours of initial training. Several different issues were 
brought up with respect to this requirement.
    The first issue was whether it was at all necessary to require 
training in breast implant imaging. Over 30 comments supported this 
requirement. These comments noted that the training was necessary to 
perform adequate examinations of women with implants and that having 
the training would remove the need to have a physician present during 
the examination. About half of these comments recommended that no 
specific amount of training be required. Eighteen comments opposed any 
requirement relating to implant imaging, arguing that technologists 
were already obtaining such training as part of their initial 
curriculum, that imaging of women of breast implants did not require 
special training, and that their facilities conducted so few 
examinations that such a requirement would be ``overkill.''
    A second issue was whether the training should be required of all 
technologists, as proposed, or just those who perform examinations of 
women with implants. One comment supported requiring it of all 
technologists in order to ensure that no matter what facility a woman 
with breast implants chose for an examination, she would be examined by 
a technologist with this training. The NMQAAC took this same position 
for the same reason. Ten other comments, however, urged that this 
requirement be limited in some way, with suggestions varying from 
limiting it to technologists who perform such examinations, to new 
technologists, or to technologists at facilities that perform a minimum 
number of examinations of patients with implants per year.
    A third issue was whether there was sufficient training available 
in this area. Approximately 25 comments stated that there would not be 
sufficient training opportunities available to meet this requirement. A 
few of these comments supported this position with data from their own 
experience or surveys of training providers in their area. This 
position is in contrast with the comments mentioned earlier, which 
stated that this requirement was not needed because training of 
patients with breast implants was already routinely being received. The 
position is also somewhat inconsistent with the 15 comments FDA 
received from technologists who said that they had received the 
required training in the past, but might have difficulty providing 
documentation because their certificates do not specifically state the 
content of the training.
    A fourth issue addressed in the comments was the proper mixture of 
classroom, video, and practical training. Eight comments stated that 
video training would have to be permitted because there would not be 
enough patients available to meet this requirement through clinical 
training. An additional 5 comments stated that it would probably not be 
possible to include clinical training. On the other hand, 20 comments 
emphasized the importance of clinical training and another 12 stated 
that it should be possible to receive this training in a clinical 
seminar. However, another comment pointed out that models would be 
reluctant to undergo the compression required by such training.
    The final issue was the amount of training that should be required 
in imaging patients with implants. Nearly 30 comments expressed the 
opinion that 5 hours was too much for reasons that included cost and 
the belief that the necessary knowledge could be conveyed in less than 
5 hours. Over 50 additional comments suggested specific and lesser 
amounts of training. About 80 percent of these comments supported a 
requirement for 2 hours of training, although some of those supporting 
2 hours would also require an additional number of examinations under 
direct supervision. Several comments also suggested stating the 
requirement in a different way, for example, as part of a larger number 
of hours devoted to positioning or in terms of a minimum number of 
patients.
    There were also a number of comments based on misunderstandings of 
the proposed requirement. Thirteen comments, for example, urged that 
the 5 hours be part of the general 40-hour training requirement, 
apparently not realizing that was already proposed. Seven other 
comments were based on the mistaken belief that implant imaging was a 
``mammographic modality'' and that training in this area would also be 
required as part of their continuing education.
    The training required for imaging patients with implants is part 
of, and not in addition to, the 40 hours of initial training and that 
the definition of mammography modality does not include breast 
implants. The agency expects to issue educational materials to help 
interpret the final regulations and will further clarify these and 
similar misunderstandings.
    In response to the comments on the five major issues, FDA first 
notes that the statute requires the agency to establish standards 
relating to special techniques for mammography of patients with 
implants (42 U.S.C. 263b(f)(1)(H)). Requiring technologists to be 
trained in examining such patients is consistent with the statutory 
requirements. In addition, FDA has received many comments, including 
advice from NMQAAC, which underscore the necessity for performing such 
examinations with trained personnel.
    The agency also notes that the grand parenting requirement will 
relieve technologists who met the interim regulations from the need to 
obtain additional training in the imaging of patients with breast 
implants. This should alleviate much of the concern that was expressed 
in comments about availability of training and the overloading of 
limited training resources. The grand parenting provision also 
eliminates the possibility that technologists who have been performing 
such examinations successfully for years but were not formally trained, 
or who do not have documentation of their training, would have to 
obtain this training. At the same time, all technologists newly 
entering the field will have to receive training in imaging of patients 
with breast implants. FDA believes this requirement strikes the proper 
balance to ensure that patients are properly examined.
    Further, after consultation with NMQAAC, FDA concluded that this 
training should not be established as a separate requirement, but 
instead should be included under Sec. 900.12(a)(2)(ii)(A) as one of the 
topics required to be covered during the 40 hours of training related 
to mammography. By including imaging of patients with breast implants 
among these required subjects, FDA ensures that all radiologic 
technologists being trained for the field of mammography will receive 
education in this important technique, as required by the MQSA. At

[[Page 55901]]

the same time, by eliminating any particular hourly requirement, the 
agency permits maximum flexibility in the amount and type of training 
received, plus some degree of assurance that the student will be 
evaluated in this area as part of the formal training process. 
Radiologic technologists who expect to examine patients with implants 
on a more frequent basis or facilities that have large numbers of such 
patients among their clients can increase the training hours in this 
subject. Conversely, radiologic technologists and facilities with few 
such examinations can devote training hours to other subjects that seem 
more beneficial to their practice, as long as the basics of imaging 
women with implants have been covered adequately. Because the hours 
devoted to such training are required to be documented contact hours 
under the supervision of a qualified instructor, a variety of types of 
training similar to those suggested in the comments could be suitable 
as long as they meet the criteria of Sec. 900.12(a)(2)(ii)(A).
    The second part of proposed Sec. 900.12(a)(2)(ii)(C), which was 
that at least 8 of the 40 hours must be training with each mammographic 
modality used by the technologist, received far fewer comments.
    (Comment 251). Five comments supported the requirement, although 
some concern about problems of documentation was expressed. Two 
comments opposed the requirement, one due to a mistaken impression 
about the number of modalities for which training would be required, 
the other because of a desire to leave the facility the flexibility to 
decide how much training was needed. Fourteen comments wanted the 
number of hours required per mammographic modality to be reduced.
    FDA believes that much of the opposition to this requirement as 
proposed arises from a misunderstanding of what is meant by 
mammographic modality. Presently, there are only two mammographic 
modalities, screen-film and xeromammography, as defined in the 
regulations. Most technologists use only one or the other and, thus, 
this requirement has no great impact on them. For those technologists 
who do, or will, work with more than one mammographic modality, FDA 
does not believe it is excessive to have at least 20 percent of the 
total amount of initial training related to each mammographic modality 
used. Therefore, this part of the proposal has been retained in the 
final regulations.
    The continuing education requirement, Sec. 900.12(a)(2)(iii), was 
the first of two, along with continuing experience, intended to ensure 
that the technologists keep their skills and knowledge base up-to-date. 
The basic requirement proposed was that radiologic technologists have 
continuing education equivalent to 15 continuing education units in a 
3-year period. The amount proposed was unchanged from that established 
under the interim regulations, but the proposed wording puts the 
emphasis on the total to be earned in a 3-year period instead of a 
yearly average.
    (Comment 252). Five comments supported the requirement as being 
flexible and adequate to keep ``technologists on top of changes.'' 
Three comments opposed it on the grounds that the continuing education 
requirements of the ARRT were sufficient or that earning the ARRT(M) 
should excuse technologists from earning continuing education credits.
    FDA is aware that the ARRT requires earning 12 credits per year 
while the proposed regulations require an average of only 15 per 3-year 
period. However, the 12 per year required by the ARRT continuing 
education standards can be from any area of radiology and will not 
necessarily be training in mammography. If the radiologic technologist 
takes mammography training to fulfill ongoing ARRT requirements, that 
training can be counted towards satisfaction of the MQSA continuing 
education standards. Similarly, while earning the ARRT(M) is evidence 
of a high level of knowledge at the time the test was taken, it does 
not ensure that the technologist will keep up with changes after that 
date, which is the primary purpose of continuing education. Thus, FDA 
cannot excuse technologists from this requirement on the basis that 
they have met the ARRT continuing education standard or have earned the 
ARRT(M).
    Two additional comments supported the idea of looking back 3 years 
for the averaging period. Ten identical comments suggested changing the 
requirement to earning 10 hours every 2 years while two others urged 
that technologists be required to earn 5 hours of continuing education 
credit each year.
    FDA established the longer time period for averaging continuing 
education credits to permit and encourage the technologists to take 
longer and more comprehensive courses as they became available. The 
agency believes such training may be more valuable than several short 
uncoordinated courses. Shortening the averaging period to 1 or 2 years 
would not prevent technologists from taking 15 credit courses, but it 
might discourage them from doing so due to a reluctance to pay for 
hours of training that would be beyond those necessary to meet the 
requirements. Use of a 3-year averaging period also provides greater 
flexibility in selecting courses that best meet individual needs and 
minimizes the possibility that a technologist will sign up for a course 
simply because it was available and the end of the year was 
approaching.
    (Comment 253). Two comments urged that continuing education in 
implant imaging be specifically required as part of the continuing 
education for technologists.
    In view of the many comments discussed earlier concerning the 
appropriate amount and type of training needed to successfully image 
patients with implants and the availability of that training, FDA has 
concluded that such a specific requirement would be too restrictive.
    (Comment 254). A number of comments were received about the number 
of continuing education units being required. Eight comments asserted 
that the requirement of an average of 5 units per year would be too 
great a burden on technologists in rural facilities. On the other hand, 
one comment suggested increasing the number of credits required to 12 
per year and provided further suggestions on the type of training, 
while another urged the requirement be raised to 10 credits per year.
    After considering these comments, FDA has concluded that the 5 unit 
per year average is reasonable. Twelve units of continuing education 
per year are required to maintain the ARRT credentials and, at this 
time, the majority of radiologic technologists practicing mammography 
have ARRT certification. Because the 5 units required by these 
regulations can be part of those 12, the final regulation does not 
establish an excessive requirement. The agency also believes that, in 
association with the requirement in Sec. 900.12(a)(2)(iii)(D) for extra 
training if the technologist begins working with a new mammographic 
modality, an average of 5 credits per year is adequate to ensure that 
the technologist keeps up-to-date.
    (Comment 255). Five comments urged that only Category A training be 
accepted, while a sixth asked for clarification on that point and a 
seventh would restrict the training to certain types without reference 
to category.
    For the reasons previously discussed, FDA does not believe that it 
is necessary

[[Page 55902]]

to restrict continuing education credits for radiologic technologists 
to Category A courses.
    (Comment 256). One comment stated that a limit should be placed on 
the number of times credit could be earned for teaching the same 
course. NMQAAC, when discussing this issue, recommended that no credit 
should be given for teaching. FDA recognizes, however, that a great 
amount of study and learning is required to successfully teach a 
course, especially the first time it is given. The agency will continue 
to permit personnel to earn credit towards the continuing education 
requirement by teaching, but has added a new provision that limits the 
times a particular course can be counted towards this requirement to 
once in any 3-year period (see Sec. 900.12(a)(2)(iii)(B)). This is 
consistent with similar provisions for interpreting physicians and 
medical physicists.
    (Comment 257). A number of comments on this section were based on 
misunderstandings. One comment expressed the belief that this 
requirement actually meant that an individual would have to earn 15 
units every 2 calendar years in order to meet this requirement. Another 
comment, incorrectly assuming that implant imaging was a mammographic 
modality, assumed that 6 hours of implant imaging training would be 
required every 3 years. Other comments mistakenly concluded that 5 
credits on implant imaging would be required every year, that the 
requirement to average 5 credits a year was being increased to 6, or 
that 5 credits were being required each and every year.
    All of these comments opposed the requirement based on their 
misunderstandings. As FDA develops educational materials to help 
personnel understand how they may comply with the new regulations, 
special attention will be focused on correcting such misunderstandings. 
Changes in the wording of Sec. 900.12(a)(2)(iii)(A) from the proposal 
are intended to emphasize that the basic continuing education 
requirement is to earn 15 credits over 3 years and to clarify options 
for calculating the time period to be used to demonstrate compliance 
with that requirement. The agency hopes that these changes will 
eliminate confusion about whether 5 units must be averaged per year or 
earned per year (the unit requirement is an average) and provide 
radiologic technologists and the facilities that employ them with some 
flexibility in maintaining and documenting compliance with this 
requirement. Both of the changes parallel similar changes made in the 
wording to the interpreting physician and medical physicist 
requirements.
    Only two comments were received on proposed 
Sec. 900.12(a)(2)(iii)(B) (now Sec. 900.12(a)(2)(iii)(C)), which 
requires a technologist to have some continuing education for all 
modalities used by that technologist. One comment stated this was a 
``great revision.'' The other expressed concerns about the availability 
of the training.
    FDA believes that if a new mammographic modality is introduced, 
training will be available initially from the originators of the 
mammographic modality because those originators will have a high 
interest in ensuring that the mammographic modality is used properly. 
FDA acknowledges that training with a disappearing mammographic 
modality, like xeromammography, may be more difficult to obtain. 
However, FDA has concluded that the possibility of detriment to the 
public health that could result from personnel not maintaining their 
skills must override this concern.
    (Comment 258). FDA received four comments on proposed 
Sec. 900.12(a)(2)(iii)(C) (now Sec. 900.12(a)(2)(iii)(D)), which 
describes requalification procedures for technologists who failed to 
meet continuing education requirements. One comment agreed with the 
provision and two comments went further to suggest that there should be 
some sort of penalty for not meeting the requirement on time. The 
authors apparently did not realize that the penalty was not being able 
to perform mammography except under direct supervision until the 
requalification was completed (see previous discussion related to 
interpreting physician). The fourth comment supported the requirement, 
but expressed concern about who would approve the training and keep the 
records of completion.
    FDA has found the mechanisms used under the interim regulations for 
approving training, which involve the participation of professional 
groups, are adequate. These same professional groups ordinarily provide 
documentation of completion. Under the interim regulations, it has been 
the responsibility of the facility to obtain and maintain such records 
and this will continue under the final regulations.
    (Comment 259). The three comments received on proposed 
Sec. 900.12(a)(2)(iii)(D) (now Sec. 900.12(a)(2)(iii)(E)) opposed the 
requirement that a technologist receive training in use of a 
mammographic modality for which she was not previously trained before 
using that modality. One comment stated that the requirement would be 
an undue hardship and two stated that it will be difficult to obtain 
the training. FDA believes that the value of being trained in the use 
of a mammographic modality before beginning to use it on patients 
overrides the hardship concern. As discussed earlier, FDA also believes 
that availability of training will not be a problem and that the 
definition of qualified instructor (Sec. 900.2(oo)) provides for an 
adequate number of teachers. The proposed requirement has been retained 
unchanged.
    Continuing experience is the second of the general requirements 
intended to ensure that the technologists maintain their skills. As 
proposed, Sec. 900.12(a)(2)(iv) required that technologists perform a 
minimum of 100 examinations during a 12-month period. This requirement 
was intended to parallel the continuing experience requirement for 
physicians.
    (Comment 260). Eight comments supported a continuing experience 
requirement for technologists, explaining that a technologist's 
positioning skills improve with additional mammography examinations. 
Nine comments opposed the requirement. Several of these suggested 
alternative measures, such as a ``lengthy appraisal (at least 3 days * 
* *) * * *'' by the chief technologist and radiologists or a 
certification program similar to that used by the American Heart 
Association for CPR certification.
    While these suggestions have merit, they are a form of proficiency 
testing and, as discussed elsewhere, large numbers of comments provided 
valid reasons to conclude that it is premature to require such testing.
    (Comment 261). Another comment opposed the requirement on the 
grounds that ``if you can do a mammogram, you can do it, period.'' The 
author's basic assumption seems to be that you never forget how to 
perform mammography. FDA notes that the purpose of continuing 
experience requirements is to ensure that technologist skills are 
maintained at a level that is likely to produce accurate and reliable 
mammograms. In view of the complexity of the examination and changes in 
technology, FDA believes that the optimism expressed by this last 
comment is unwarranted.
    (Comment 262). Proposed Sec. 900.12(a)(2)(iv)(A) set the continuing 
experience requirement at the performance of at least 100 mammography 
examinations in a 12-month period. One comment stated that this was a 
``very acceptable requirement,'' but two believed that it

[[Page 55903]]

should be higher. One of these recommended that the number should be 
the same as the 480 interpretations a year required of radiologists. 
Four comments supported the level of the requirement, but asked that 
the averaging period be longer than a year to allow technologists to be 
absent for longer periods and still be able to meet the requirement. 
Two of these comments noted that physicians are allowed a 24-month 
averaging period for their continuing experience. Ten other comments 
suggested that the number be lowered, with 50 or 75 a year being the 
most common suggestions.
    FDA has concluded that the number of 100 per year, which was first 
suggested by NMQAAC in February 1994, and supported by them at their 
January 1997 meeting, is the most reasonable compromise between the 
need to establish a requirement sufficiently high to maintain skills 
and the need to avoid disqualifying large numbers of competent 
technologists. The agency notes that as few as two examinations per 
week will be sufficient to meet this requirement.
    FDA does agree with the suggestion that the averaging period be 
lengthened to 24 months and the wording of the regulation has been 
changed to require the performance of 200 examinations in a 24-month 
period. A clarification of how to determine the 24-month period was 
also added, which parallels similar provisions for calculating such 
time periods for interpreting physicians and medical physicists.
    (Comment 262a). Seventeen comments identified specific groups that 
they believed would have difficulty meeting this requirement. These 
included individuals, such as mammography supervisors, instructors, and 
technologists in sales, who had made career choices that would make it 
difficult for them to meet this requirement.
    FDA understands the desire of these individuals to keep their 
options open in case they wish to return to the performance of 
examinations, but the agency believes that higher priority must be 
given to maintaining technologist proficiency. FDA also notes, as 
discussed later, that a requalification procedure has been provided for 
technologists in this situation.
    (Comment 263). A related concern was expressed in the 13 comments 
that indicated technologists in rural hospitals would have difficulty 
meeting this experience requirement. As explained previously, FDA 
recognizes that rural facilities face special challenges but believes 
that it would be contrary to the MQSA goal of assuring women a uniform 
minimum level of quality of mammography nationwide to establish lesser 
standards for technologists practicing in rural areas.
    As proposed, Sec. 900.12(a)(2)(iv)(B) stated that technologists who 
fail to meet the continuing experience requirement can re-establish 
this qualification through the performance of 50 mammography 
examinations under direct supervision.
    (Comment 264). Ten comments stated that this number of examinations 
was too many and suggested that it be reduced, with 30, 25, and 20 
examinations all being proposed. Another comment urged that there be a 
penalty for failing to meet this requirement, apparently not realizing 
that the penalty was not being able to work independently until 
requalification was completed. One comment urged that proficiency 
testing be used instead of an experience requirement, while another was 
concerned about how the performance of these examinations would be 
documented.
    As discussed above, FDA has reduced the number of examinations that 
have to be performed under direct supervision as part of the initial 
training from 50 to 25. The agency has no reason to require the 
requalification figure to be higher than the number of examinations for 
initial qualification. Accordingly, the agency has similarly reduced 
the requalification requirement from 50 to 25 examinations.
    d. Medical physicist (Sec. 900.12(a)(3))
    Section 900.12(a)(3) establishes the requirements that must be met 
by medical physicists who conduct surveys of mammography facilities and 
provide oversight of the facility quality assurance program. Initial 
qualifications, alternative initial qualifications, continuing 
qualifications, and the reestablishment of qualifications are all 
covered. No major changes have been made in the final regulations from 
what was proposed. Some changes have been made in the survey experience 
requirement and in the averaging time for the continuing qualifications 
requirement. The comments received on the final regulations in each of 
these areas are discussed in below in connection with the specific 
provisions.
    (Comment 265). One comment stated that the proposed rule is very 
positive, ensuring that only properly trained and adequately qualified 
professionals perform medical physics surveys. Another comment 
concluded that the medical physicist qualifications were appropriate 
and reasonable.
    The initial qualification requirements for medical physicists 
include board certifications or State licensure or approval; masters 
degree or higher in physical science with 20 semester hours in college 
or graduate level physics; 20 contact hours of training in mammography; 
and survey experience.
    The proposed initial qualifications requirements generated a wide 
spectrum of comments. Views varied greatly on the value of State 
approval or licensure in ensuring that physicists were properly 
qualified to perform mammography services.
    (Comment 266). Ten comments expressed doubt that State approval/
licensure provided a sound basis for establishing competence. One 
comment recommended that the State approval option be deleted, while 
another suggested that State approval be accepted only after FDA 
investigation. One comment stated that State approval/licensure should 
be part of alternative criteria with additional appropriate training 
and experience requirements. Three comments argued that State approval 
or licensure should be specific to the State where the professional 
practice will occur, unless a State reciprocity mechanism is in place. 
One comment stated that the proposal was unclear as to whether State 
approval was sufficient or additional requirements would need to be met 
after October 1997. On the other hand, seven comments stated that State 
approval, like board certification, was adequate by itself and that 
additional requirements were not needed.
    Five comments stated that board certification should be required 
for all medical physicists. Several other comments urged FDA not to 
accept board certification without requiring a special certificate for 
mammography. Two comments recommended deleting the master's degree 
requirement and argued that course work in college level physics and 
supervised experience should be adequate. One comment contended that 
the issues of degree, training, and curricula are unnecessarily 
complicated in the proposed regulation. Another comment stated that the 
requirement of board certification or State licensure unfairly excludes 
physicists who are otherwise well qualified to test mammography 
equipment on the basis of their actual experience in this field. One 
comment stated that these requirements are appropriate.
    FDA considered all of the comments received concerning initial 
qualifications requirements for medical physicists. Because the MQSA 
expressly establishes State approval or licensure

[[Page 55904]]

as an alternative pathway (42 U.S.C. 263b(f)(1)(E)(i)), FDA could not 
eliminate this route for initial qualification, even if the agency 
believed it was desirable to do so. The agency is aware that not all 
States have adequate minimum qualifications standards. Concern has also 
been expressed that some board certified physicists do not have 
adequate experience with mammography equipment. Therefore, as proposed, 
FDA added additional educational and experience requirements for all 
physicists, regardless of which initial route they follow to become 
qualified under the MQSA. These additional requirements are: (1) For 
initial qualification, masters degree or higher in physical science, 
with a minimum 20 semester hours or equivalent in college or graduate 
level physics, 20 contact hours of training in mammography, and 
experience of surveying 1 facility and 10 units; and (2) for 
alternative initial qualification, bachelors degree or higher in 
physical science, with a minimum 40 semester hours or equivalent in 
college or graduate level physics, 40 contact hours of training in 
mammography, and experience of surveying 1 facility and 20 units.
    (Comment 267). A number of comments suggested that additional 
subjects, such as mathematics, biology, nuclear physics, and radiologic 
technology should be added as acceptable fields in which the degree may 
be obtained. Some comments wanted the reference to physical science to 
be changed to medical physics. One comment stated that physicists who 
are not board certified should be required to demonstrate a stronger 
educational background than currently required. In response to the 
agency's discussions in the preamble section of the proposal about the 
possibility of requiring all 20 semester hours in imaging physics (61 
FR 14905), two comments stated that such a requirement would not be 
appropriate because the mammography equipment evaluation would require 
more than training in imaging and limiting 20 semester hours to imaging 
physics would not provide the physicist with the education needed to 
adapt to constant changes in technology.
    The agency has decided to keep the requirement of physical science 
as the field in which the degree must be obtained and believes that its 
definition of physical science (Sec. 900.2(jj)) sufficiently covers the 
wide range of subfields that can provide adequate initial training to 
enable an individual with 20 semester hours of physics to understand 
the basics of mammography physics. The agency believes that this would 
not be the case if other fields, such as biology, were added to the 
definition.
    (Comment 268). Sixteen comments stated that board-certified 
physicists should not have to demonstrate compliance with the 
additional educational requirements of Sec. 900.12(a)(3)(i)(B)(1) in 
the proposed regulations, but should demonstrate experience conducting 
mammography surveys. Because the MQSA establishes board certification 
and State licensure/approval as equivalent pathways for qualifying 
medical physicists, FDA has not issued different additional 
qualifications for each of these groups. Accordingly, the agency has 
retained this requirement as proposed. However, if a designated board 
confirms that its certification in an accepted speciality always 
requires the minimum of a masters degree in physical science with at 
least 20 semester hours in physics, the agency may not have to verify 
the degree and semester hour requirements during annual inspections for 
those physicists certified by that board.
    Another initial requirement is that physicists have 20 contact 
hours of documented training in mammography. Several comments requested 
further clarification of contact hours. Some comments urged FDA to 
accept self attestations of contact hours for experienced physicists 
who have worked in the field for a long time but do not have any 
documented contact hours. Ten comments stated that, if the medical 
physicist is board certified, the contact hours requirement should not 
apply.
    After considering these comments and consulting with NMQAAC, FDA 
has retained contact hour requirements for all physicists, regardless 
of which initial route they followed to become qualified. FDA will 
accept self attestation of any contact hours received before October 
1994. The agency has also provided a more detailed description of 
contact hours in Sec. 900.2(m).
    Under the proposal, an additional initial requirement was that 
medical physicists shall have the experience of surveying at least 5 
facilities and 10 units.
    (Comment 269). About one hundred comments opposed the requirement 
for multiple facility surveys for in-house physicists and stated that 
in-house physicists who are employed by hospitals and medical schools 
are often contractually prohibited from performing surveys at outside 
facilities. Several of these comments suggested that FDA should instead 
base its requirement on number of unit surveys.
    In response to these comments, the agency has revised this 
requirement so that physicists qualified under Sec. 900.12(a)(3)(I) 
will be required to have initial experience of one facility and ten 
unit surveys. FDA did not eliminate the facility requirement entirely 
because the agency strongly believes that having experience with 
complete surveys of facilities, including oversight of all QC records, 
is necessary. Evaluations of units only cannot provide a medical 
physicist with the same experience and knowledge as the survey of a 
facility. Although the amended regulation does not mandate survey 
experience with more than one facility, the agency encourages all 
physicists to perform additional facility surveys when possible to 
expand their experience. FDA believes that it is also advisable to gain 
familiarity with a number of different mammography units because much 
of the educational benefit is lost if the same unit is surveyed 
repeatedly to meet the experience requirement. In order to address this 
concern to some degree, the regulation now provides that no more than 
one survey of a specific unit within a period of 60 days can be counted 
towards the total mammography unit survey requirement.
    The initial experience requirement also stated that, after the 
effective date of these regulations, the initial survey experience must 
be acquired under the direct supervision of a qualified medical 
physicist.
    (Comment 270). One comment stated that direct supervision would be 
very difficult to arrange. Another suggested requiring two surveys 
under direct supervision and the rest under indirect supervision. The 
comment stated that indirect supervision with telephone consultation 
and advice is more valuable than the direct supervision.
    FDA has retained this requirement because the agency and NMQAAC 
consider it important that new physicists entering the field acquire 
initial experience in conducting mammography surveys under the direct 
supervision of a qualified medical physicist, who can correct any 
mistakes made during the learning process before they pose to a threat 
to patients. Because this provision does not take effect until the 
effective date of the regulations, the agency believes that it will not 
disrupt the availability of experienced medical physicists.
    Alternative initial qualifications were established in 
Sec. 900.12(a)(3)(ii) to provide a way to permit medical physicists who 
have been successfully providing mammography physics services for some 
time, but who lack a masters degree, to continue to practice

[[Page 55905]]

without lowering quality standards in any manner that would jeopardize 
public health. In general, in order to qualify by this alternative 
qualification route, an individual must have qualified under 
Sec. 900.12(a)(3) of the interim regulations and maintained his or her 
licensure, approval, or certification requirement as required under the 
interim regulations. The physicist using this alternative route is also 
required to have a bachelors degree or higher in physical science, with 
at least 10 semester hours or equivalent in college level physics, 40 
contact hours of training in mammography, and survey experience of 10 
facilities and 20 units.
    (Comment 271). Several comments opposed the alternative pathway for 
initial qualifications and considered the proposed educational 
requirements for these medical physicists to be inadequate. On the 
other hand, a larger number of comments shared FDA's concern for 
existing medical physics service providers and the facilities they 
serve. These comments supported this alternative qualifications route 
and recommended that experienced individuals who have previously 
qualified and who meet continuing education and experience 
qualifications should be allowed to continue to practice. Five comments 
stated that the alternative initial qualifications should be a 
permanent option. One comment claimed that the proposed alternative 
qualifications criteria were too restrictive to permit many State 
licensed physicists to qualify.
    A number of comments suggested increasing the requirement of 
semester hours of college level physics for this alternative route from 
the proposed number of 10. Some comments suggested that the credit 
hours requirement for this alternative route be increased from 10 to 15 
or 20 hours by including subjects such as biology, radiation biology, 
radiation science, and chemistry. Other comments expressed concern that 
this college level physics requirement would bar a number of presently 
qualified physicists from continuing to provide mammography services. 
Two comments stated that the requirement for semester hours in physics 
should be removed, and that physicists qualified under the current 
interim regulations by the State licensure or approval process should 
not have to meet additional educational requirements. One comment 
stated that 10 hours of physics is reasonable. Another comment stressed 
that formal training in physical science is necessary and stated that 
this standard should not be weakened.
    In the preamble to the final regulations, the agency explained its 
reasons for proposing the alternative initial qualifications route for 
physicists with bachelors degrees who are currently performing 
mammography physics services under the interim rule (62 FR 14905). 
Based upon discussions with NMQAAC and the Conference of Radiation 
Control Program Director's Task Force on Medical Physics Criteria, the 
agency proposed the requirements for course work in physics, contact 
hours, and experience included in this alternative route. The agency 
believes that the combination of all these requirements provides 
adequate protection for the public health, while permitting most 
practicing physicists to continue to provide mammography services under 
the final rule.
    Moreover, the agency considered it to be unfair to individual 
physicists and potentially detrimental to facilities and the public to 
exclude many currently practicing physicists by withdrawing the 
alternative initial qualifications route or by increasing the 
educational credit hours requirement for these individuals in the 
absence of evidence that such physicists are providing inadequate 
services. The agency was concerned that such an exclusion could cause a 
possible shortage in the availability of physics services for some 
period of time.
    Several comments supported the views expressed in the preamble to 
the proposed rule. In addition, the agency's experience and data 
gathered from its inspection data base affirm that many currently 
practicing medical physicists with bachelors degrees, adequate course 
work in physics, and substantial experience are performing quality 
medical physics surveys in mammography facilities with care and 
competence.
     The agency continues to believe that it is very important to have 
at least 10 semester hours in college or graduate level physics. The 
other subjects, suggested by some comments, will not necessarily 
provide an individual with the necessary background and training to 
understand the basics of mammography physics. However, because at least 
a bachelors degree in physical science is also part of the educational 
requirement, the credit hours in other related subjects, suggested by 
the comments, may be associated with fulfilling the degree requirement. 
Although the agency believes that a minimum of 10 hours of course work 
in physics is necessary to gain proper physics background, it also 
believes that requiring more credit hours in physics, as some comments 
and some members of NMQAAC suggested, will exclude individuals other 
than physics minors or majors or those with graduate degrees. For these 
reasons and those previously stated in the proposed rule (61 FR 14905), 
the agency has retained, as proposed, the minimum requirement of a 
bachelors degree with no less than 10 semester hours or equivalent 
courses in physics in its final rule on alternative initial 
qualifications.
    The agency agrees, however, that enhanced educational 
qualifications are necessary in order for physicists entering the field 
in the future to have the required background to understand the 
technology of the future as it becomes increasingly intricate. As 
previously proposed, therefore, FDA is limiting the use of this 
alternative pathway to only those physicists who have met its 
requirements by the effective date of the final regulations.
    (Comment 272). Several comments opposed the contact hours 
requirement, while some supported it.
    The agency has previously stated its justification for retaining 
this requirement for initial qualification route. For the same reason, 
the agency will retain the requirement for the alternative route.
    (Comment 272a). A large number of comments stated that the proposed 
initial experience requirement of 10 facilities and 20 unit surveys for 
the alternative route in Sec. 900.12(a)(3)(ii)(B)(3) would be 
impossible to achieve for many in-house physicists and suggested 
eliminating the reference to the number of facilities.
    In order to be consistent with the initial requirements for 
physicists under Sec. 900.12(a)(3)(i)(B)(3), the agency has revised 
Sec. 900.12(a)(3)(ii)(B)(3) to change the required initial experience 
from conducting surveys of at least 10 mammography facilities and 20 
units to conducting one facility and 20 unit surveys. Again, no more 
than one survey of a specific unit within a period of 60 days can be 
counted towards the total mammography unit survey requirement.
    (Comment 272b). Two comments stated that the experience component 
under the alternative initial requirement should have to be fulfilled 
under the direct supervision of a qualified medical physicist, as 
required under Sec. 900.12(a)(3)(i)(B)(3). Another comment suggested 
changing the effective date of this regulation to the effective date of 
this section because there is more than one effective date in these 
regulations.
    The agency points out that Sec. 900.12(a)(3)(i)(B)(3), which will 
take effect 18 months after these regulations

[[Page 55906]]

are published, will affect only new medical physicists entering the 
field. Because Sec. 900.12(a)(3)(ii)(B) establishes that the 
alternative pathway is only available until the effective date of the 
final rules, the direct supervision requirement does not apply to the 
individuals qualified through the alternative pathway, because no one 
will enter the field through that pathway following the effective date 
of the rules. In response to the comments about varying effective dates 
in the proposed rule, FDA points out that, except for some of the 
equipment standards and equipment QC tests, all sections of the final 
rule will be effective 18 months after publication. This is clearly 
stated in the final rule.
    The continuing qualifications requirements for medical physicists 
have two components: Sec. 900.12(a)(3)(iii)(A) continuing education, 
which requires the physicist to earn 15 units over 3 years; and 
Sec. 900.12(a)(3)(iii)(B) continuing experience, which requires the 
physicist to survey 2 facilities and 6 units over 24 months.
    (Comment 273). One comment questioned FDA's authority to require 
continuing education at all.
    In response, FDA observes that the MQSA is designed to provide the 
government with authority to issue and enforce standards to ensure 
safety and accuracy of mammography in the United States. The section of 
the statute relating to quality standards lists a variety of 
requirements for each group of personnel associated with mammography 
practice. Although only the requirements relating to interpreting 
physicians expressly includes a reference to continuing education, 
these requirements are not an exclusive or limited list of standards to 
be established by the agency. They represent only the minimum 
requirements that Congress mandated that the Secretary must ``include'' 
among those issued to ensure safety and effectiveness of mammography 
(42 U.S.C. 263b(f)(1)). Just as FDA has determined that continuing 
education is necessary to maintain the skills and expertise of 
radiological technologists, the agency has concluded that continuing 
education requirements are also essential for medical physicists, who 
play a critical role in guaranteeing the safe operation of equipment 
and effective quality assurance systems.
    (Comment 274). One comment stated that these requirements are 
appropriate. Two comments asserted that self training by reading and 
studying should qualify. Other comments asked that continuing education 
units be better defined. Another comment stated that the language was 
too prescriptive. One comment stated that most medical physicists would 
have completed rather than taught continuing education units and 
another opposed giving repeated credit for a course taught several 
times. One comment maintained that no CME has been available for those 
who have tested Xerox systems for the last 5 years, and that such 
courses are unlikely to be available in the future.
    FDA notes that the final rule establishes that the units earned 
through teaching of a specific course can only be counted once towards 
the 15 education units requirement. A new definition for continuing 
education unit or credit has been added in Sec. 900.2(l). The agency 
will accept only the continuing education credits offered by 
professional organizations whose training is shown to be relevant and 
acceptable for medical physicists. Language clarifying the options for 
calculating the 3-year period has also been added. The agency 
understands that sufficient training opportunities may not be available 
in xeroxmammography. However, because only 0.5 percent or less of the 
facilities use xeromammography, the agency believes that the majority 
of physicists, if not all, will need only continuing education related 
to screen-film mammography. When other mammographic modalities, such as 
digital mammography, become available, medical physicists will need 
continuing education in those areas. The agency believes that such 
training will be increasingly more available as the technologies 
develop. The agency advises the facilities that use xeromammography to 
contact the manufacturer of this system to provide or arrange for 
training in xeromammography.
    (Comment 275). One comment recommended that the second and 
subsequent 3-year periods begin to run from the original date that the 
physicist was required to meet the continuing experience qualification.
    FDA decided to use a floating 3-year period for all mammography 
personnel, instead of a fixed 3-year period as suggested by the 
comment, for two reasons. First, as explained previously, a fixed 
period actually allows an individual to go much longer without 
continuing education than the length of the period itself. With a 3-
year fixed period, for example, if an individual received training near 
the beginning of one period and near the end of the next period, he or 
she would go nearly 6 years without continuing education, which is 
entirely too long in a changing field such as mammography. Second, 
because inspections are annual, if an inspector found that an 
individual had not met the continuing education requirement during the 
previous fixed period, that individual might have provided services to 
the facility for almost a year before the failure was discovered. 
Depending upon the circumstances, the actions needed to correct the 
consequences of using the services of a noncompliant individual could 
require a considerable amount of time and money on the part of the 
facility.
    (Comment 276). Two comments stated that persons providing 
continuing education should meet the qualifications of a medical 
physicist as described in the proposed regulations and that the 
instructors should be in active practice.
    FDA disagrees. The agency believes that many scientists, university 
professors, and equipment manufacturers can provide training in 
different aspects of mammography physics.
    (Comment 277). Another comment claimed that it is excessively 
bureaucratic to require that a physicist send a copy of his or her CME 
to include in the operating manuals, as was insisted upon by an 
inspector at their facility.
    FDA believes that the author of the comment misunderstood the 
reason why the information on CME was required to be sent to the 
facility. The reason was not for inclusion in the facility's operating 
manual but to enable the facility to demonstrate that its medical 
physicist met the continuing education requirement. All interpreting 
physicians, radiologic technologists, and medical physicists providing 
services to mammography facilities have to document that they meet the 
continuing education requirement.
    (Comment 278). One comment stated that there should be some penalty 
for failing to meet the continuing education requirements.
    The consequences of failure to maintain these requirements is the 
inability to work independently as a medical physicist. As stated with 
respect to other mammography personnel, the agency believes this 
penalty is the most effective means to guarantee that physicists 
maintain qualifications and to protect the public health.
    Under the proposal, FDA would require medical physicists to 
maintain their skills through the survey of at least 3 mammography 
facilities a year.
    (Comment 279). More than 50 comments opposed this requirement. As

[[Page 55907]]

expressed in related comments, in-house physicists may be contractually 
prohibited from surveying outside facilities. Many of these comments 
suggested deleting the reference to the number of facilities.
    In response to these comments and in order to establish consistency 
with revisions to the initial experience requirement discussed above, 
FDA has revised the proposed continuing experience requirement. The 
requirement will be for surveys of two facilities and six units in a 
24-month period. The same facility can be surveyed twice. However, as 
with the initial experience requirement, no more than one evaluation of 
a specific unit within a period of 60 days may be counted towards the 
requirement. In addition, while the same facility may be surveyed twice 
within this 24-month period by an individual physicist in order to meet 
this requirement, the two surveys by this physicist must be at least 10 
months apart. This restriction does not prohibit the facility from 
having surveys more frequently than once every 10 months, if it wishes 
to do so out of quality concerns or for other reasons. The restriction 
only limits the number of surveys of that facility that an individual 
physicist can use to meet his or her continuing experience requirement. 
The reduction in the number of facilities will address the concerns 
that were raised about in-house physicists.
    In order to be consistent with the equivalent physician and 
technologist requirements, the continuing experience requirement for 
physicists is now based upon a 24-month period. This will now make it 
more feasible for physicists who are out of the field for a time, e.g., 
on maternity or sabbatical leave, to maintain their qualifications. The 
requirement has also been amended to explain options for identifying 
the 24 months that will be used to determine compliance. This change 
parallels similar changes in the requirements for radiological 
technologists and interpreting physicians and is intended to provide 
personnel and facilities with additional flexibility for monitoring 
compliance with these standards.
    Section 900.12(a)(3)(iii)(C) requires physicists to be trained to 
do surveys of a mammographic modality for which they have not 
previously received training before independently doing surveys of such 
units.
    (Comment 280). A number of comments correctly pointed out that the 
reference to mammographic ``examinations'' should actually be to 
mammographic ``surveys'' or ``evaluations.''
    FDA has corrected this error by replacing the word examination with 
survey.
    (Comment 281). Several comments opposed the requirement for 8 hours 
of training in a new mammographic modality prior to doing a survey of 
such a modality. One comment expressed concern that this will keep 
physicists from surveying new modalities. Another comment suggested 
that length and degree of training be commensurate with the specifics 
of the new modality. Two comments stated that the requirement 
overestimated the complexity of new modalities and undervalues the 
physicist's capability of adapting to new modalities in medical 
imaging. One comment stated that this rule is unnecessary because a 
qualified physicist will be able follow guidelines developed by ACR and 
AAPM when a new modality, such as digital mammography, begins to be 
used by the facilities. One comment stated that 8 hours of training in 
a nonscreen-film modality would be difficult to complete, while another 
comment stated that only expert instrument manufacturers would be 
qualified to provide such training.
    The agency continues to believe that the proposed requirement of 8 
hours of training in a new mammographic modality before a medical 
physicist may begin performing surveys independently in that type of 
modality is reasonable and necessary. Training prior to practice using 
a new mammographic modality is required for all critical personnel 
(interpreting physicians, radiologic technologists, and medical 
physicists) because FDA has determined that the benefits to patients 
from such prior training outweighs the cost to individuals and 
facilities. The agency recognizes that training in a new modality may 
not be widely available and agrees with comments that have observed 
that equipment manufacturers would and should be able provide such 
training. The agency will encourage manufacturers of a new mammographic 
modality, such as digital mammography, to provide or arrange for such 
training when the modality is commercially marketed.
    Section 900.12(a)(3)(iv) describes measures medical physicists may 
take to reestablish their qualifications if they have failed to meet 
their continuing qualifications requirements.
    (Comment 282). Two comments stated that the surveys of facilities 
and units required for reestablishing qualifications should be 
consistent with the experience requirement for initial qualifications. 
The authors believed that, if a medical physicist is not actively 
involved in mammography facility surveys for an extended period of 
time, performing the proposed three surveys may not be enough to regain 
the required expertise. They recommended that the requirement for 
requalifying be increased to five supervised surveys. One comment 
supported the qualification's supervision requirements. Another comment 
questioned why physicists are not allowed to perform surveys without 
the supervision of a qualified physicist, while such supervision is not 
required for physicians and technologists.
    The agency notes that this provision has been amended to be 
consistent with similar provisions relating to physicians and 
technologists. In order to reestablish qualifications, physicists must 
perform facility and unit surveys to bring their total up to the 
required survey of 2 facilities and 6 units in the previous 2 years. 
This change also makes the requirements for continuing experience 
qualification more consistent with the experience requirements for 
initial qualification, as suggested by some comments. Any survey 
performed by a physicist to bring his or her total up to the 
requirement must be under the direct supervision of a qualified medical 
physicist. Contrary to the assumption in one of the comments, 
physicians and technologists who fail to meet their continuing 
experience requirement are also required to reestablish their 
qualifications under direct supervision and cannot resume working 
independently until the requalification is complete.
    e. Retention of personnel records (Sec. 900.12(a)(4))
    The provision on retention of personnel records Sec. 900.12(a)(4) 
is intended to describe the personnel records that must be kept by the 
facility to establish that their personnel meet the MQSA requirements 
and to indicate how long such records should be kept.
    (Comment 283). Ten comments disagreed with the proposal by FDA to 
allow records to be discarded following the next annual inspection and 
the resolution of any personnel problems discovered during that 
inspection. These comments urged that records be required to be kept 
for longer periods, with ``as long as the person is employed at the 
facility'' being the maximum suggestion. Four more comments suggested 
that FDA also establish requirements for how long records of staff 
members who have left the facility should be kept. One comment noted 
that the list of the people for whom records were required in the 
proposal included darkroom personnel and pointed out there were no 
specified qualifications for such individuals. Two

[[Page 55908]]

comments suggested that, if mammography is performed at various sites 
under the same ownership, the records be kept only at one site and be 
sent to the separate facilities as needed. Finally, one comment 
expressed the opinion that keeping personnel records was an unnecessary 
burden, but made no suggestions as to how personnel qualifications 
could be verified without documentation.
    FDA has made a number of changes in this requirement in response to 
the comments. First, to address the concern about inclusion of darkroom 
personnel, the list of activities performed at a facility has been 
replaced with a reference to those personnel for whom quality standards 
have been issued. The wording was further changed to clarify that, as 
long as an individual is employed at a facility in one of these 
capacities, records must be available to show that the individual meets 
all qualifications. Records for individuals who have left the facility 
may be discarded after the next inspection has occurred and FDA has 
determined if the individual met the requirements. Although nothing in 
the MQSA or these final regulations precludes the facility from 
retaining these records for longer periods of time, FDA does not expect 
to have further need to review such records following the subsequent 
inspection. In response to comments suggesting that multi-site 
facilities retain personnel records in a central location, FDA notes 
that such a practice would be permitted but is not required under the 
final rule. Because the MQSA inspections are typically announced in 
advance, a facility could store its records at one site and bring them 
to the other sites as needed for review during the inspections there.
2. Equipment (Sec. 900.12(b))
    The requirements were intended to establish specifications to 
ensure that each facility would have equipment that is capable of 
producing quality mammograms. FDA made a number of significant changes 
in the equipment requirements that were proposed. These changes include 
removing several of the requirements proposed for phase-in 5 and 10 
years after the publication of the final rule and moving several 
requirements from Sec. 900.12(b) to the quality assurance paragraph in 
Sec. 900.12(e). Most of the test procedures that would have been 
required under the proposal have also been deleted. Each of these 
changes will be discussed below.
    a. General comments on equipment
    (Comment 284). A number of comments raised issues that did not 
address specific provisions proposed under Sec. 900.12(b), but were 
directed generally toward the entire package of regulations governing 
equipment. These included two comments that expressed a blanket support 
for the regulations proposed under Sec. 900.12(b).
    One comment stated that it would be useful to have a better 
delineation of responsibility for ensuring that units meet particular 
standards under the MQSA. The comment recommended that the facility 
medical physicist be designated as the individual responsible to ensure 
that a facility's equipment is in compliance.
    FDA believes responsibility for compliance with all the MQSA 
requirements rests ultimately with the facility. Within the scope of 
each facility's individual operations, responsibility can be 
apportioned as the facility wishes, so long as this is consistent with 
the regulations. The suggestion made by the comment is not inconsistent 
with the regulations. Under Sec. 900.12(d)(1)(iv), the medical 
physicist is designated as the individual responsible to oversee the QC 
requirements, though no provisions specifically require routine QC 
testing to be performed by the medical physicist.
    (Comment 285). Three comments suggested that FDA cannot anticipate 
future changes in mammographic equipment technology sufficiently well 
to be able to determine all appropriate requirements in this area over 
this extended timeframe. One of these recommended that FDA review the 
equipment requirements on a continuing basis to recommend and propose 
modifications that are recognized to promote quality mammography. One 
comment suggested that FDA simply require all mammography X-ray units 
to be replaced every 8 to 10 years in order to keep facilities upgraded 
with standardized equipment.
    FDA agrees that it cannot anticipate all changes in mammography 
equipment over the next 10 years and has not attempted to do so. In the 
proposed regulations, FDA simply incorporated specifications of current 
equipment that experts had deemed desirable for quality mammography 
systems. The goal of the proposal was to ensure that, 10 years in the 
future, each facility would be using equipment that was considered 
state-of-the-art in today's market. FDA approached this goal by 
phasing-in the requirements over various time periods. Equipment 
requirements considered most fundamental to the delivery of quality 
mammography would be required first, followed by those specifications 
considered useful but which, because of cost impact, could be delayed 
for a period of 5 years. The third phase under the proposal included 
``nice to have'' features that are not absolutely necessary to the 
production of quality mammograms and would not be required until the 
end of a 10-year period. However, based on the uncertainty surrounding 
the need for the phase three requirements, consultation with NMQAAC and 
industry representatives, assessment of the costs associated with some 
of the proposed 5-year phase-in requirements, and consideration of the 
public comments, FDA has determined that this goal is inconsistent with 
efforts to keep the costs associated with the delivery of mammography 
services at a manageable level. The agency has, therefore, decided to 
eliminate many of the requirements that had been proposed for both 5- 
and 10-year phase-in. FDA has previously stated that it plans to 
periodically review the regulations for necessary revisions in response 
to new technology and remains committed to that effort. The agency 
intends to and will revisit these areas in the future to reassess the 
need for additional regulations.
    Although the revised equipment standards do not mandate that each 
facility have all the equipment features the agency originally had 
proposed, FDA believes the final regulations establish basic 
requirements that ensure that every facility meets the baseline 
equipment standards necessary to perform safe and accurate mammography. 
In response to the comment that recommended requiring new equipment 
every 8 to 10 years, FDA does not believe that the costs associated 
with the arbitrary replacement of mammography equipment every 8 years 
to 10 years is justifiable. In addition, the agency notes, too, that 
the alternate standards provisions, included in the regulations under 
Sec. 900.18, provide the flexibility needed to ensure that new and 
innovative advancements reach the market without unnecessary delay.
    (Comment 286). Two comments recommended that all detailed testing 
procedures be eliminated from Sec. 900.12(b) to allow flexibility for 
qualified medical physicists to determine the appropriate testing 
methodology.
    FDA has, in large part, adopted this approach in the final 
regulations. In doing so, the agency has placed responsibility on the 
medical physicists to be able to justify the procedures that they 
utilize to perform testing of equipment in any particular facility.

[[Page 55909]]

    (Comment 287). One comment suggested that the X-ray tube companies 
are ``planning for early tube retirement so they can replace the tubes 
frequently at high cost to the facilities.'' The comment asked FDA to 
address this issue immediately in an effort to keep mammography costs 
down.
    FDA does not control the pricing of equipment in the marketplace. 
The agency is, however, interested in equipment problems that may 
indicate a unit does not meet its specifications and/or aspects of 
compliance that it is certified as meeting. Specific information about 
manufacturers should be submitted to the Office of Compliance in FDA's 
Center for Devices and Radiological Health, 2094 Gaither Rd., 
Rockville, MD 20850.
    (Comment 288). One comment suggested that there should be a lock-
out and/or alarm mechanism preventing a mammography technologist from 
exposing the patient to radiation without placing film in the 
equipment. Another comment suggested a requirement for an interlock to 
prevent a second exposure until the cassette is changed, and two more 
comments recommended a requirement for an interlock to ensure the 
presence of a cassette in the bucky/film holder. These comments noted 
that such incidents have occurred, needlessly exposing patients to 
radiation multiple times because the technologist forgot to insert or 
change the film.
    Although FDA is aware that some manufacturers include interlocks 
that ensure the presence of a cassette or that cassettes are changed 
after each exposure on their equipment, FDA is not considering such 
requirements at this time. FDA believes that, unlike equipment 
performance, this is an aspect of the mammography process that is 
within the complete control of the technologist and that the 
technologist must assume responsibility for preparing the system for 
each exposure. In facilities where more than one technologist uses the 
equipment, a check list of items should be followed and this should 
most certainly be one of the items on the list. If the technologists 
adequately follow standard procedures, incidents such as those 
described in the comments can be prevented without incurring the 
considerable expense involved in requiring the suggested interlocks.
    (Comment 289). One comment asked the agency to consider requiring 
special grounding devices to protect operators and patients. The 
comment also suggested a prohibition against carpeting in the 
mammography room, and a requirement for the use of static mats around 
the mammography machine.
    Although these items might be desirable they do not impact the 
quality of the mammography image and are beyond the scope of these 
regulations.
    (Comment 290). One comment suggested that a requirement 
establishing a maximum distance from the surface of the patient support 
to the sensitive part of the image receptor should be incorporated in 
Sec. 900.12(b).
    FDA is not aware, and the comment did not offer evidence to show, 
that this represents a problem for current mammography systems. 
Accordingly, the agency is not planning to regulate this aspect of 
equipment performance.
    (Comment 291). One comment suggested that the maximum allowable 
photo-timed exposure for mammography applications should be specified. 
The comment stated that the backup limit of 2,000 mA's (from 21 CFR 
1020.31(a)(3)(iii) in the Performance Standards for Diagnostic X-ray 
systems and their major components) was clearly selected based on prior 
technology, i.e., much slower screen-film systems or, perhaps, 
industrial X-ray film where exposures were typically on the order of 
5,000 milli Roentgen (mR) for an average breast.
    FDA notes that the regulations under 21 CFR 1020.31 presently set a 
limit of 2,000 mA's for automatic exposure control equipment when 
operating with a peak tube potential under 51 kVp. This regulation is 
not specific to mammography, but applies to any diagnostic X-ray 
equipment operating with a peak tube potential under 51 kVp. In 
previous draft regulations presented to NMQAAC, a lower value of 600 
mA's was proposed for mammography systems. The committee was of the 
opinion that 600 mA's was too low and FDA planned to increase the value 
to 800 mA's. In the meantime, FDA received comments from industry 
pointing out that some systems have variable SID capability. This 
variability in current equipment undermines an approach that relies on 
the maximum mA's concept because the mA's required at a longer SID may 
be significantly greater than that required at a shorter SID, although 
the dose delivered might remain constant. Because FDA was faced with 
setting dose limits for the termination of the exposure or 
unnecessarily limiting equipment SID, the agency decided that the 
maximum allowable photo-timed exposure should not be prescribed in the 
regulations at this time. This decision was presented to NMQAAC, which 
had no comment. FDA may revisit this area in future proposals.
    (Comment 292). One comment noted that the time between exposure of 
the film and photographic processing is critical because the latent 
image on all film decays with time.
    FDA had considered this aspect of the imaging process for 
regulation but, based on comments from the public and NMQAAC, decided 
not to propose requirements at this time. This area may be revisited in 
the future when more is understood about the requirements and practices 
in the mobile mammography community, where film processing often must 
be delayed for a significant period of time after exposure.
    (Comment 293). Several comments recommended that FDA set standards 
for batch variability of film, stating that this variability is often 
greater than that proposed for the equipment standards.
    FDA recognizes that the variability of film may be a potential 
problem but believes that facilities can control this, to a significant 
degree, through their purchasing specifications and selection of 
suppliers. FDA will monitor this problem closely to determine if future 
regulation is required.
    (Comment 294). Twenty-five comments recommended that FDA include 
requirements for the viewbox and/or the viewing conditions for the 
physician and technologist.
    FDA agrees such standards would be beneficial, but does not believe 
that enough is known, at this time, to set appropriate specifications 
for viewing conditions. The guidelines recommended by ACR are excellent 
and the agency encourages facilities to follow them. FDA will consider 
this subject for future regulation and all relevant comments will be 
reconsidered at that time.
    (Comment 295). Thirty-nine comments expressed concern that the cost 
of some or all of the equipment regulations would cause facilities to 
close and thereby restrict access for patients. Many of these comments 
urged that the equipment requirements should be made to apply to 
manufacturers of equipment for items manufactured after the specified 
effective date of the regulations. A related comment suggested that the 
current interim rule, which requires only that equipment be 
specifically designed for mammography, is working well and that further 
regulation proposed under Sec. 900.12(b) will serve only to stifle 
invention, add cost, and ``overly rigidify'' this important aspect of 
providing the highest quality mammography services at the lowest cost 
to the public.

[[Page 55910]]

    FDA can understand why the last comment believes the interim 
regulations are far less extensive than what was proposed. The interim 
regulations address the equipment aspect of mammography quality 
directly by listing four criteria that all X-ray systems used for 
mammography must satisfy: (1) The X-ray equipment must be specifically 
designed for mammography; (2) it must be certified to meet the 
performance standards in 21 CFR 1020.30; (3) it must have a removable 
grid; and (4) it must have a compression device. In addition, however, 
the interim regulations required each facility to undergo an annual 
survey in accordance with the standards specified in the 1992 or 1994 
ACR QC manuals (see Sec. 900.12(d) and (e) of the interim regulations). 
These manuals outline extensive requirements for the equipment 
associated with the mammography process. In the final regulations, FDA 
has not referenced these manuals although NMQAAC strongly advised their 
continued use and has instead included specific requirements that were 
part of the ACR standards under final regulations at Sec. 900.12(b) and 
(e). Although they appear as new regulations, many of these new 
provisions merely restate requirements that previously had been 
referenced through the ACR manuals but are now reformatted as 
regulation.
    FDA is also concerned about all costs associated with the 
regulations under the MQSA, including those incurred by the purchase, 
upgrade, and repair of equipment. However, FDA's authority under the 
MQSA relates to the user of the equipment rather than the manufacturer. 
Under authority granted to FDA by provisions of the act (which 
incorporates the Radiation Control for Health and Safety Act of 1968), 
FDA is pursuing a parallel path to generate standards for new equipment 
under Sec. 1020.30. This process will take some time and regulations on 
new equipment only gradually affect the installed base. The agency 
concluded that regulations directed at new equipment only, and not the 
installed base, would have inappropriately delayed the benefits of the 
improvements provided by the new equipment for millions of women for a 
number of years.
    For these reasons, FDA determined that equipment standards 
implementing the MQSA should be directed to the installed base to 
ensure that all women, not just those that utilize facilities with new 
equipment, receive an adequate and equal baseline of care. Based on 
facility inspection experience with the interim regulations, FDA does 
not expect a large reduction in providers and anticipates no access 
problems solely as a result of the equipment regulations. In addition, 
FDA has provided mechanisms for alternate standards in Sec. 900.18 to 
allow for innovation and flexibility under the final rule. The agency 
has no reason to believe that the regulations will cause stagnation in 
the market for new and useful equipment.
    (Comment 296). One comment asked if it was necessary to attempt to 
codify and regulate equipment standards that, in the respondent's 
opinion, will evolve anyway through competition in the market.
    Again, the agency responds that the introduction of new products 
into the market place can be a slow process and waiting for 
manufacturers to manufacture and market and for users to purchase would 
not produce the change in minimum national standards that FDA perceives 
is needed. Additionally, in FDA's experience, certain segments of any 
market are often driven by price concerns rather than features or 
performance. FDA believes that regulations are the only mechanism that 
will provide the impetus to achieve the desired baseline of care in a 
reasonable time.
    (Comment 297). One comment supported phasing in the equipment 
standards over the next 1 to 10 years, as discussed in the preamble to 
the proposal (61 FR 14909). Two comments stated that 5 years is not a 
sufficient amount of time to require the purchasing of new equipment 
and maintained that it would be more appropriate to allow a longer 
phase-in period, for example, 10 years.
    Five comments offered a contrary point of view, suggesting that the 
majority of the mammography equipment presently in use meets most of 
the proposed standards in Sec. 900.12(b) and that many of the 
timeframes proposed in Sec. 900.12(b) are excessively long. One of 
these comments expressed concern that there are some facilities where 
the machine limits the ability to do adequate imaging and the facility 
will not get newer equipment if not forced by law to do so.
    FDA appreciates these comments and recognizes that some facilities 
will not upgrade their equipment until the last possible moment, 
thereby using equipment that has become inadequate by current 
standards. The agency must balance these concerns with cost concerns 
that facilities, patients, and FDA all share. The decision to require 
certain equipment standards to be phased in relatively quickly and 
postpone others represents the agency's efforts to balance these 
competing concerns.
    (Comment 298). One comment suggested that there should be 
regulations for needle biopsy systems in Sec. 900.12, including 
provisions that address misalignment of the biopsy cross-hair. The 
comment stated that the cross-hair assembly, if not accurately aligned, 
may lead to inaccurate localization of lesions during needle 
localization, increasing the possibility of morbidity. FDA recognizes 
the need for regulation in this area and has raised the issue with 
NMQAAC in the past. As a result of discussions with NMQAAC and opinions 
offered by the ACR, the decision was made to delay regulations for this 
aspect of breast radiography until community consensus can be reached 
on all aspects of the process. As discussed earlier, FDA is currently 
working internally on possible regulations for interventional 
mammography, while awaiting the results of collaborative efforts 
between the ACR and the American College of Surgeons to reach consensus 
on recommendations for standards in this area.
    (Comment 299). One comment recommended that the equipment 
specifications proposed under Sec. 900.12(b) should not be included in 
the final regulations and that the entire section should be issued as 
guidance rather than a binding regulation.
    FDA has considered this approach, but has determined that, because 
the guidelines would not have the force of law, they would not achieve 
the widespread results necessary to meet the goals of the MQSA.
    (Comment 300). Nine comments expressed concern that the proposed 
regulations under Sec. 900.12(b) were not specific as to whether all 
equipment in a facility must comply and one of these comments 
questioned if existing mammography units must be redesigned and/or 
upgraded to all the standards by the effective dates.
    FDA intends that all facilities performing mammography shall meet 
each of the final regulations by the effective date of each 
requirement. In the case of equipment, all equipment used for covered 
mammography procedures must meet the requirements in effect at any 
given time. If equipment must be repaired, replaced, or upgraded to 
achieve this result, then such actions must be completed by the 
effective date or the facility must discontinue offering mammography 
services with the nonconforming equipment until compliance is achieved.
    (Comment 301). One comment stated that the equipment standards 
sometimes

[[Page 55911]]

give very specific descriptions of testing equipment and procedures. 
For example, in proposed Sec. 900.12(b)(4)(iv), FDA specifically 
described a 12 cm diameter acrylic disc 1.5 cm thick. The respondent 
was unsure why 12 cm was specified instead of 10, and why 1.5 cm was 
specified instead of 1 or 2.
    FDA notes that in each case where test procedures and/or test 
objects are specified in these final regulations, the objects or 
procedures are usually based on established test protocols. In some 
cases where the test object itself could be variable, the 
specifications are identical to an object used in another required test 
in order to reduce the number of items required for the entire survey 
or inspection. In cases where the test or the test object is new, the 
details of its design are beyond the scope of this document. FDA 
intends, whenever possible, to issue guidance documents that will 
address the use of such new procedures and equipment. The particular 
example cited in the comment has been deleted from the final 
regulations.
    (Comment 302). One comment stated that the proposed rules are not 
entirely consistent with the guidance document developed by ACR and 
CDC. The comment recommended that every effort should be made to ensure 
consistency with the ACR guidance document.
    FDA is, of course, aware of the ACR/CDC document and, in fact, 
adopted many of its requirements for these final regulations. However, 
the ACR/CDC document was written as a guideline for new equipment and 
not as a regulation for installed equipment. As a guideline, its 
wording would not readily transfer to regulation and, as a 
specification for new equipment, its scope was not sufficiently broad 
to address the range of the installed base or the cost concerns 
associated with upgrade and replacement of equipment. The agency also 
notes that the recommendations in the ACR/CDC guidance represent an 
attempt to describe an optimal system. NMQAAC and members of the public 
have stated that some of the features, while desirable, would generate 
costs not justified by the expected benefit, especially when applied to 
the installed base. In those cases where the agency believes the 
benefit does not warrant the cost, FDA has not made particular features 
regulatory requirements. Within these limitations, FDA has generally 
made efforts to remain consistent with the ACR/CDC guidance where doing 
so is appropriate.
    (Comment 303). One comment suggested that a section in 
Sec. 900.12(b) or (e) should address the issue of screen placement in 
the cassette. The comment noted that, because the screen is sometimes 
not positioned with its edge in contact with the inside wall of the 
cassette at the chest wall, the film edge is underexposed or unexposed. 
The comment suggested that ``such cassettes should be rejected and the 
screens remounted.''
    FDA agrees that such conditions should not exist, but believes the 
annual survey and normal QC procedures will identify and correct such 
problems and is not considering regulations to address this concern at 
this time.
    (Comment 304). One comment recommended that the proposed equipment 
regulations in Sec. 900.12(b) be rewritten to correspond more closely 
with existing international standards.
    In certain aspects of equipment related requirements, FDA has 
attempted to conform to both national and international precedent. 
However, in some cases, those guidelines are inappropriate or do not 
address the specific concern being considered under the MQSA.
    (Comment 305). One comment suggested that the proposed requirements 
of Sec. 900.12(b)(17) through (21), which do not relate to X-ray 
equipment or film processors, should be included as part of the annual 
physics survey and need not be specified by regulation. FDA believes 
that this respondent misunderstood these provisions because the core of 
the annual physics survey is, in fact, set forth in these regulations. 
Some of these regulations have been modified and/or transferred to the 
quality assurance section of the final regulations, while others have 
been deleted. The remaining requirements may be checked as survey or 
inspection items, verified by documentation provided by the 
manufacturers, or established through normal QC procedures performed by 
the facility. Although the agency has not expressly prescribed how 
these requirements should be met in all cases, FDA has determined that 
the facility is responsible for establishing compliance with these 
standards rather than trusting that they would be included in all 
medical physicists routine surveys.
    b. Prohibited equipment (Sec. 900.12(b)(1))
    This paragraph prohibited the use for mammography of general 
purpose equipment or equipment designed for special nonmammography 
procedures.
    (Comment 306). Seven respondents recommended that the use of 
xeromammographic equipment should be prohibited or phased out.
    FDA considered taking this action but believes that the unique 
characteristics of the xeroradiographic process may provide a valuable 
tool in the diagnosis of some cases. Records obtained during the first 
year of facility inspections under the interim regulations indicate 
that there are an extremely small number of these units in service and 
it is believed that the number will continue to decrease as their use 
falls out of favor with the community. FDA has concluded, therefore, 
not to ban their use.
    c. General (Sec. 900.12(b)(2))
    This paragraph, as proposed, required that all equipment be 
designed for mammography and certified under Sec. 1020.30.
    (Comment 307). One respondent suggested that a definition of 
``specifically designed for mammography'' be included because some 
units may be used for imaging of extremities.
    FDA does not believe that this is necessary because the 
manufacturer's labeling, along with the FDA device approval process, 
ensures that the design is appropriate for mammography. FDA recognizes 
the fact that the characteristics of mammography radiographic equipment 
make it useful for other radiological examinations and does not intend 
to restrict such applications if the product has also been approved for 
that use.
    d. Motion of the tube-image receptor assembly (Sec. 900.12(b)(3))
    This paragraph proposed that the gantry be capable of specific 
rotation, that the angle of the gantry be indicated, and that the tube-
image receptor assembly remain rigidly fixed in any position where it 
was designed to operate.
    (Comment 308). Two comments noted a citation error in the proposed 
regulations. One comment recommended the deletion of the entire 
section, with the possible exception of requiring the system to remain 
fixed when placed in an operating position. Three other comments 
supported the proposed requirements, although one suggested that only 
one unit at each facility need meet the requirements. NMQAAC supported 
the proposed requirements, with the recommendation that they be 
applicable only to equipment acquired 5 or more years after the 
publication of the final regulations.
    FDA has determined that NMQAAC's recommendation to require 
compliance only on equipment acquired 5 or more years after publication 
of the final regulations presents major problems with respect to 
enforcement. Such an approach would produce a situation where two 
distinct levels of quality would be in place for different facilities

[[Page 55912]]

and often within the same facility, based on when equipment was 
acquired. After reviewing the public comments and assessing the 
possible cost impact of the requirements, FDA decided to remove the 
provisions detailing the range of gantry motion and angle indication. 
If this area is considered for future regulation, all comments 
submitted on these sections will be reconsidered in the process. FDA 
has reworded the provision that requires the tube-image receptor 
assembly to remain fixed in its designed operating positions and this 
requirement remains under Sec. 900.12(b)(3) in the final regulations. 
The citation error has been corrected.
    e. Image receptor sizes (Sec. 900.12(b)(4))
    This paragraph requires that all mammography systems have, at a 
minimum, both a 18 X 24 cm and 24 X 30 cm screen-film receptor and 
matching grids, and that the grids should be removable. This section 
also proposed that grid motion should not be impeded when a breast is 
subjected to compression in the system.
    (Comment 309). Seven comments supported the proposal regarding the 
image receptor sizes and matching grid requirements proposed in 
Sec. 900.12(b)(4)(i). Two comments opposed the specification requiring 
both a large and a small image receptor system in the regulations. One 
of these misread the proposal as being applicable to xeromammographic 
equipment and suggested that the regulation might prohibit the use of 
such equipment because such systems may not provide multiple image 
receptor sizes. The other comment supported the concept of requiring a 
large and small image receptor combination, but opposed a provision 
specifying the actual dimensions of these receptors. A related comment, 
while not actually opposing the proposal, expressed concern that 
requiring multiple image receptor sizes for screen-film systems might 
establish difficult precedents for future technology.
    FDA believes that, for the present and foreseeable future, the 
dominant film sizes used in screen-film mammography will remain 18 X 24 
and 24 X 30 cm and has not been persuaded to revise the provision that 
requires systems to have both sizes with corresponding grids. The 
agency believes that the last comment is concerned with digital systems 
currently under development and the concern that large or multiple 
sized image receptors would be prohibitively expensive with such 
systems. FDA has not formulated an opinion in this area and will wait 
to see what final technology and configurations evolve for digital 
systems before addressing this issue in regulation.
    (Comment 310). One comment, while neither agreeing nor disagreeing 
with the requirement for multiple size image receptors, stated that the 
use of smaller image receptors, even on large breasts, results in 
clearer, sharper images and noted that larger areas compressed all at 
once do not provide the sharpness and detail needed to pick up very 
small cancers. The comment stated that, even though more films are 
taken when a smaller film size is used to image a large breast, the 
benefits of finding a life-threatening cancer far outweigh the minimal 
increase in radiation exposure to the patient.
    FDA recognizes this practice as essentially the ``spot 
compression'' of the entire breast in multiple exposures. Although 
``spot compression'' can yield improved images, it is not a recognized 
or accepted procedure in screening mammography. Interpreting physicians 
who deem such studies necessary will order them to be performed, but it 
is not standard practice for routine screening. The agency also notes 
that the regulation merely requires that the two-image receptor sizes 
be available; their use in any particular case is left to the judgment 
of the mammography personnel involved.
    (Comment 311). One comment proposed that the requirement for 
multiple image receptor sizes be restated to require at least one unit 
at the facility to provide the multiple sizes, rather than requiring 
each unit to have both receptors. Experts on NMQAAC recommended that 
the requirements of Sec. 900.12(b)(4)(i) not be weakened by permitting 
a facility to satisfy this equipment standard by having only one system 
with the multiple cassette sizes. The rest of the committee agreed. FDA 
has accepted this advice and retained this requirement under 
Sec. 900.12(b)(4)(i).
    Section 900.12(b)(4)(ii) requires facilities to have systems with 
moving grids matched to all image receptor sizes provided.
    (Comment 312). One comment commended FDA for requiring both an 18 x 
24 and a 24 x 30 bucky for each unit. Another recommended that the 
regulation read: ``Systems using screen-film image receptors shall be 
equipped with separate moving grids matched to all image receptor sizes 
provided.'' FDA does not believe that the suggestion was a significant 
improvement and did not make the change.
    (Comment 313). One comment recommended the inclusion of a 
requirement in Sec. 900.12(b) that specifies the image receptor support 
device shall match the cassette size.
    The agency does not believe this additional requirement is 
necessary. By requiring the system to have both a large and small image 
receptor and corresponding sized grid assemblies, FDA is confident that 
most technologists will select the appropriate receptor and cassette 
size for each patient.
    Section 900.12(b)(4)(iii) requires the grid to be removable for 
systems used for magnification.
    (Comment 314). Three comments requested clarification regarding 
applicability and intent of this provision.
    FDA notes that the final regulation was drafted to clarify the 
interim rule. Section 900.12(b)(4)(iii) simply states that the system 
must be operable with the grid removed from between the source and the 
image receptor when the technologist is performing magnification 
procedures. This could be accomplished in various ways, including 
actually removing the grid mechanism, substituting a nongrid film 
holder for the grid film holder assembly, or any other mechanism that 
ensures that the grid does not interfere with the image or the 
automatic exposure control, if one is used.
    Under Sec. 900.12(b)(4)(iv), FDA proposed that the grid motion not 
be impeded when the breast is compressed and also proposed detailed 
requirements for verifying compliance.
    (Comment 315). Seven comments supported the proposed requirements 
for assessment of grid related artifacts, while 14 comments supported 
the concept of evaluating grid related artifacts, but opposed both 
listing the requirement in regulation and the test procedure outlined 
in the proposal on the basis that the test method was unproven and 
objective standards for evaluation of the seriousness of the problem 
were lacking. In April 1996, and again in January 1997, NMQAAC 
recommended removing Sec. 900.12(b)(4)(iv) regarding the grid related 
artifacts.
     FDA has accepted NMQAAC's recommendation and removed this 
paragraph.
    (Comment 316). Twelve comments requested justification, 
clarification, or suggested modifications for the test procedure 
proposed under Sec. 900.12(b)(iv). If the issue is revisited for future 
regulation, the comments to this section will be reconsidered at that 
time.
    f. Beam limitation and light fields (Sec. 900.12(b)(5))

[[Page 55913]]

    This paragraph covers devices for limitation of the X-ray field and 
specifies light localizer characteristics.
    Under Sec. 900.12(b)(5)(i), FDA proposed that all systems ensure 
that the X-ray field can extend to or beyond the chest wall edge of the 
image receptor.
    (Comment 317). Two comments interpreted this as a requirement that 
the collimator must provide separate adjustability on the chest wall 
edge and suggested that such adjustability is unnecessary.
    FDA accepted these comments and reworded Sec. 900.12(b)(5)(i) to 
clarify that the intent is not that the collimator be adjustable, but 
that the collimator allow complete coverage of the image receptor at 
the chest wall edge unless it is the intent of the operator to not do 
so. This requirement has been moved to the quality assurance section 
and appears in Sec. 900.12(e)(5)(vii).
    Section 900.12(b)(5)(ii) proposed that any system with a light 
field that appears to approximate the X-ray field must approximate the 
X-ray field to a specified tolerance and that the light must produce a 
minimum specified brightness. Four comments supported the alignment 
recommendations with the observation that, in the respondents' 
opinions, the alignment was more important on the chest wall edge.
    (Comment 318). Two comments expressed disagreement with this 
requirement. In Sec. 900.12(b)(5)(ii), FDA also proposed a definition 
for the mammographic source to image receptor distance (SID) that was 
changed slightly from the definition used for more general purpose 
radiographic systems in order to be more consistent with the actual 
usage in mammography. Two comments supported this change, two opposed 
it, and one respondent expressed concern that the definition of SID in 
this section might be confusing.
    After reviewing the comments, FDA has determined that the 
requirements for the alignment of the light field and X-ray field and 
the definition of SID are adequately addressed by existing regulations 
in Sec. 1020.31, and has deleted the proposed requirements from this 
standard. A QC test to verify alignment now appears in the quality 
assurance section at Sec. 900.12(e)(5)(vii).
    With respect to the proposal that the light provide a minimum 
illuminance, two comments supported the requirement and four comments 
opposed it.
    FDA notes that this proposed requirement is the same as that 
currently required for general purpose systems covered by Sec. 1020.31. 
Thus, it already applies to such collimators using such light 
localizers on mammography systems. FDA has chosen to restate the 
specification here to eliminate any confusion and to clarify that the 
general requirement also applies to mammography equipment. The 
restatement now appears under Sec. 900.12(b)(5)(ii) in the final 
regulations.
    Under Sec. 900.12(b)(5)(iii), (iv), and (v), FDA proposed a phase-
in of additional requirements. The first stage required all mammography 
systems to incorporate such a light localizer 5 years after 
publication. The second stage required that 10 years after publication, 
all mammography systems were to prevent X-ray production unless the 
correct combinations of field size and image receptor were selected and 
to prevent any exposure with an X-ray field exceeding the size of the 
image receptor support device.
    (Comment 319). Three comments supported the requirement for the 
light field as proposed, with one of these urging that it be instituted 
at the earliest date the regulations become effective. One comment 
agreed that a light field, as proposed, may be a desirable feature but 
thought properly trained personnel are able to position the breast 
correctly without a light and suggested that the requirement should be 
deleted because, in the respondent's opinion, the cost would be too 
high to justify. NMQAAC supported the requirement for a light field, as 
proposed. Four comments supported the proposed requirements in 
Sec. 900.12(b)(5)(iv) and (v) but one of these suggested that a means 
to override the interlocks should be provided. One comment opposed both 
proposals.
    FDA has reevaluated these proposals and concluded that they raise 
safety concerns related to X-ray systems in general rather than image 
quality concerns. For this reason, and the cost concerns discussed 
previously, the agency has decided to delete both Sec. 900.12(b)(5)(iv) 
and (v) from these regulations and to develop such requirements under 
the authority provided in the act for regulatory products subject to 
the Radiation Control for Health and Safety Act of 1968. Accordingly, 
FDA is discussing relevant changes to part 1020 with its Technical 
Electronic Product Radiation Safety Standards Committee.
    After the revisions to the proposal were completed, there remained 
only two paragraphs in this provision: Sec. 900.12(b)(5)(i), requiring 
beam limiting devices that allow the useful beam to extend to or beyond 
the chest wall edge of the image receptor; and Sec. 900.12(b)(5)(ii), 
which establishes the illuminance requirement.
    g. Source-image receptor distance (SID) (proposed 
Sec. 900.12(b)(6))
    FDA proposed requirements for a minimum SID for mammography systems 
and specified that the SID must be displayed. The agency also proposed 
an accuracy specification for that display. In Sec. 900.12(b)(6)(i), 
FDA proposed that all mammography systems have a minimum SID of at 
least 55 cm.
    (Comment 320). One comment recommended that FDA include a 
definition of ``contact mammography'' as used in Sec. 900.12(b)(6)(i) 
to eliminate confusion about its meaning. Another comment supported the 
minimum SID as proposed, and six comments supported the concept but 
recommended that the minimum SID be reduced to 50 cm; NMQAAC supported 
the proposal as published.
    In considering these comments and other more general comments 
relating to avoidance of unnecessary specifications that may limit 
future technology, FDA has decided that other requirements in the final 
regulations (dose, resolution/focal spot condition, and system output) 
make issuing this requirement unnecessary. Therefore, the limitation on 
the SID has been removed from the final regulations. In the future, if 
the agency determines that regulations covering this area are required, 
all relevant comments will be reconsidered at that time.
    In Sec. 900.12(b)(6)(ii), FDA proposed that each system should 
provide a visual indication of the SID, accurate to within 2 percent.
    (Comment 321). One comment stated that the actual SID needs 
definition or that there should be specification of an acceptable 
method of verifying the SID or location of the focal spot. Other 
comments were concerned with uncertainties in determining the end 
points of the SID. One comment noted that the indication of the SID 
proposed in Sec. 900.12(b)(6)(ii) might differ between systems because 
of differences in interpretation of the location of the image receptor. 
Conversely, another comment suggested that the concept of an indication 
of the SID, as proposed in Sec. 900.12(b)(6)(ii), is ambiguous for 
those systems having multiple focal spots and anode tracks because all 
focal spots are not at the same location on the anode. The comment 
further suggested that the ``source'' be defined as the average 
location of all focal spots.
    Another comment noted that the standards in IEC 601-1-3(point 
29.203.2) specify a tolerance of 5 percent for the SID indicator and 
requested that FDA consider adopting that specification rather than the 
2 percent proposed. One comment suggested that FDA might wish to

[[Page 55914]]

consider recasting the proposal of Sec. 900.12(b)(6) as an outcomes 
specification. Another comment recommended that the proposed 
requirement in Sec. 900.12(b)(6)(ii) for indication of SID be restated 
to require the indication only for variable SID units. NMQAAC 
recommended that the section be deleted because they believed that it 
would add to the equipment costs with little benefit to the quality of 
mammography.
     FDA has accepted the NMQAAC recommendation and deleted 
Sec. 900.12(b)(6)(ii). If this issue is revisited, all comments will be 
reconsidered at that time.
    h. Magnification (Sec. 900.12(b)(6) (proposed Sec. 900.12(b)(7)))
    As proposed, this paragraph required that systems used for 
procedures beyond basic screening mammography have magnification 
capability available to the user.
    (Comment 322). One comment suggested that the proposal was unclear 
as to the intent of ``available to the user.'' One comment incorrectly 
assumed that, because there was no implementation date for the 
requirement, all diagnostic equipment installed presently have 
magnification capability and will meet the requirement. One comment 
expressed concern that this requirement made his facility's equipment 
obsolete and stated that most diagnostic mammography does not require 
magnification.
    The radiologists on NMQAAC stated that magnification is needed for 
noninterventional problem solving mammography. The committee debated 
whether to recommend to delete or change these provisions and decided 
not to recommend such actions.
    FDA has retained the provision, but reworded parts of the proposal 
to clarify the intent. The changes include replacing the term 
``diagnostic mammography'' with ``noninterventional problem solving 
mammography.'' This change was necessary because there is no general 
consensus as to the definition of ``diagnostic mammography.'' ``Problem 
solving mammography'' refers to mammography requiring techniques beyond 
those utilized in standard mammography of asymptomatic patients and 
``noninterventional'' indicates that the procedures are noninvasive in 
nature. The term ``available to the user'' simply means that any 
attachments or accessories necessary to allow the X-ray system to 
perform magnification procedures must be present with the system and 
available to the technologist to encourage and facilitate the use of 
the feature.
    (Comment 323). Four comments recommended that the specification be 
reworded to require the facility to have the capability to provide 
magnification instead of requiring that each system provide the 
feature. However, the experts on NMQAAC stressed the importance of 
requiring the feature in each system used for such procedures and FDA 
has retained the requirement.
    In Sec. 900.12(b)(7)(ii) of the proposal, FDA specified that at 
least one magnification setting should be in the range of 1.4 to 2.0. 
One comment suggested that the use of magnification greater than 1.5 is 
questionable and that limits for the image quality and average 
glandular dose should be set for these conditions.
    FDA agrees, in principle, with this comment. Generally, 
magnification for these procedures is accepted within the range 
specified by the requirement and most sources seem to agree that 
magnification at approximately 1.5 is optimal. FDA believes that by 
requiring the equipment to provide magnification in the optimum range 
the facility will then be able to adequately perform the procedure. 
Some systems currently used for magnification will not meet this 
standard. This will not, in itself, however, force the replacement of 
the equipment because the unit may still be used for the general 
population ``screening'' of asymptomatic patients so long as it meets 
the other requirements.
    (Comment 324). One comment noted that ``magnification setting'' as 
used in the proposal was not defined. Another comment stated that the 
method of determining the magnification, along with acceptable limits, 
should be specified or referenced. FDA has removed the word 
``settings'' from the requirement because it might be confusing but has 
not added a definition of ``magnification'' to Sec. 900.2; FDA believes 
that the term is generally understood to be the ratio of the source-to-
image receptor distance to the source-to-object distance.
    Because the proposed SID requirements were moved, proposed 
Sec. 900.12(b)(7) Magnification has been codified as Sec. 900.12(b)(6).
    i. System resolution (proposed Sec. 900.12(b)(8))
    This paragraph proposed requirements for the system resolution for 
both contact mode and magnification mode mammography.
    (Comment 325). Nine comments requested that a test procedure be 
specified for the contact mode requirement proposed in 
Sec. 900.12(b)(8)(i). One comment suggested that a specification of the 
appropriate resolution target should be included along with a 
specification of its position in the test plane, and a requirement for 
an absorber in the beam to lengthen the exposure times, because very 
short exposures may introduce interference from gridlines.
    FDA agrees with these comments and has included a description of 
the test conditions in the final regulations.
    (Comment 326). One comment correctly noted that the requirements in 
proposed Sec. 900.12(b)(8)(i) and (ii) attribute failure to meet 
resolution requirement to problems with the focal spot when, in fact, 
the cause of observed low resolution values may be some other component 
in the imaging chain.
    FDA agrees with this comment and has rephrased the requirement.
    Based on recommendations from NMQAAC, FDA has removed this 
requirement from the equipment standard and established a QC 
requirement for system resolution that is codified under 
Sec. 900.12(e)(5)(iii).
    In Sec. 900.12(b)(8)(ii), FDA proposed regulating the system 
resolution in the magnification mode. Based on guidance received from 
NMQAAC, FDA has moved this requirement to the quality assurance 
provisions in Sec. 900.12(e)(5)(iii), and has designated it for phase-
in after 5 years. If, in that time, other values are determined to be 
more appropriate, the regulations will be modified accordingly.
    Thus, proposed Sec. 900.12(b)(8) System resolution, no longer 
appears among the equipment requirements.
    j. Focal spot selection (Sec. 900.12(b)(7) (proposed 
Sec. 900.12(b)(9)))
    As proposed, this provision included several requirements for 
indication of the focal spot selected for use in examinations, 
interlocking of the focal spot with selected kVp, and alignment of the 
focal spot with the image receptor. FDA also proposed that the system 
indicate which focal spot and, where applicable, which focal spot 
material is selected prior to exposure. The proposal also recognized 
that some systems may automatically select the focal spot during the 
exposure and required a post exposure indication of the focal spot used 
during such exposures.
    (Comment 327). Three comments, including that of NMQAAC, 
recommended that the requirements proposed in Sec. 900.12(b)(9)(ii) and 
(iii), concerning indication of the target material, be linked with an 
``or.''
    FDA did not accept this recommendation because it would essentially 
eliminate the requirement for post-exposure indication of the machine 
selected focal spot. The agency believes that the change would modify 
the

[[Page 55915]]

requirement in a way the agency does not intend or desire because it 
would permit the equipment to display only the initial preselected 
focal spot and never indicate the actual focal spot used.
    (Comment 328). Two comments supported the proposal in 
Sec. 900.12(b)(9)(iv) that the system be interlocked to prevent 
exposure with improper or incompatible combinations of kVp and target 
material. One comment opposed this requirement, two requested 
clarification, and one requested a test procedure. NMQAAC recommended 
that the initial clause in the proposal be deleted.
    After further consideration of this requirement, FDA concluded that 
the requirement was already adequately covered by requirements relating 
to diagnostic X-ray systems in Sec. 1020.30(m) and has deleted proposed 
Sec. 900.12(b)(9)(iv).
    k. Focal spot location (proposed Sec. 900.12(b)(10))
    This paragraph proposed a requirement that the focal spot be 
located in a specific geometric relationship to the image receptor.
    (Comment 329). One comment supported the requirement, five 
(including NMQAAC) opposed it, believing that it was unnecessary, three 
requested clarification on its testing, and one, recognizing its 
relationship to the compression paddle alignment, recommended that the 
provision be moved to the section on compression paddle alignment.
    FDA accepted the NMQAAC recommendation and deleted this requirement 
from the final rule.
    l. Filtration (proposed Sec. 900.12(b)(11))
    This proposed paragraph contained a statement requiring mammography 
systems to comply with the beam quality standards for half-value-layer 
(HVL) codified at Sec. 1020.30(m)(1).
    NMQAAC recommended that the section specifying the HVL requirements 
should be moved to the QC section. FDA accepted this recommendation and 
codified the requirements for filtration under Sec. 900.12(e)(5)(iv).
    (Comment 330). One comment suggested that the proposed rule in 
Sec. 900.12(b)(11)(i) was too vague and subject to arbitrary 
interpretations. Another comment recommended that more precise rules be 
used to determine the required HVL and suggested that existing dose 
tables could be used to determine the desired limits. The respondent 
based this position on the fact that Sec. 1020.30(m)(1) requires the 
interpolation or extrapolation of HVL values in the mammographic range. 
One comment noted that filtration is not the same as HVL; the HVL 
measure indicates the filtration that is in the X-ray system, but it is 
not an actual measurement of filtration. Two comments noted that the 
proposed regulations refer to Sec. 1020.30(m)(1) for the minimum 
filtration requirement and incorrectly interpreted this as a lack of 
specification for kVp's not listed. They asked what FDA is planning to 
do concerning the perceived lack of regulation of filtration for kVp's 
below 30 kV since the table of HVL specifications does not list any 
values below 30 kV. One comment stated that some realistic values for 
expected HVL at ranges of 25 to 30 kVp should be given. One comment 
stated that Sec. 900.12(b)(11)(i) seems less specific than current 
requirements for filtration and another comment suggested that the 
requirement in Sec. 900.12(b)(11)(i) should be referenced to the most 
recent ACR physics manual instead of Sec. 1020.30(m)(1).
    FDA believes that the comments indicate that relationship between 
filtration and half-value-layer (HVL) in the mammographic energy range 
and the concept of mathematical extrapolation and interpolation may not 
be fully understood by some members of the mammography community. It is 
generally understood that the first HVL is an indirect measurement of 
the filtration in the X-ray beam. In the kVp range up to 50 kVp, the 
values specified in Sec. 1020.30(m)(1) represent a beam with an 
inherent filtration equivalent to 0.5 mm of type 1100 aluminum. FDA 
notes that, although the standard relates the HVL in terms of type 1100 
aluminum, it does not specify that the same alloy be used to measure 
the HVL. Therefore, the measurement of the first HVL and the comparison 
of the result to the specification indicate whether the system has 
sufficient filtration in the beam; if the first HVL is less than the 
number specified in the table, there is insufficient filtration because 
the HVL is a function of the filtration and the energy of the X-ray 
beam (kVp).
    In response to the comments, FDA has provided a table of the 
extrapolated values of HVL in the mammography kVp range under the 
quality assurance provisions in Sec. 900.12(e)(5)(iv). Values not shown 
may be derived by interpolation. FDA believes that providing these 
values, which are derived from the Federal performance standard at 21 
CFR 1020.30(m)(1) and are serendipitiously identical to the ACR 
recommended values when the paddle is not in the beam, makes it 
unnecessary to reference the ACR manuals or any other external source 
of HVL values.
    (Comment 331). Five comments supported a specification of a maximum 
filtration requirement in Sec. 900.12(b)(11)(i) and another comment 
recommended that a maximum HVL, specified as a function of kVp, be 
added for each known combination of anode and filter materials. One 
comment noted and agreed with the deletion of the upper limits for HVL 
that had been proposed in previous drafts of the proposed regulations.
    FDA deleted those upper limits because it had concluded that other 
aspects of performance and image acceptability will serve to limit the 
maximum filtration. Comments to the proposal have not persuaded the 
agency to reverse that position.
    (Comment 332). One comment noted that Sec. 900.12(b)(11)(i) 
references Sec. 1020.30 and questioned the need to repeat the 
requirement. The comment also found the proposal ``redundant with 
Sec. 900.12(b)(2),'' which requires equipment to be specifically 
designed for mammography. FDA does not agree that the references are 
redundant and has concluded that the restatement in this regulation 
serves to clarify and reinforce the Sec. 1020.30 specification.
    One comment suggested that the regulation be recast in terms of 
desired outcomes and offered this example: ``The type and quantity of 
filtration interposed between the source and the breast entrance 
surface shall be such as to provide the maximum subject and image 
contrast consistent with limitations on dose (Sec. 900.12(c) of the 
interim regulations) and minimum half-value layer 
(Sec. 1020.30(m)(1)).''
    FDA believes this suggestion would introduce an unacceptable level 
of subjectivity into the evaluation process without eliminating the 
need to reference the specification in Sec. 1020.30(m)(1).
    FDA also reconsidered the requirements in Sec. 900.12(b)(11)(ii) 
for variable filtration systems, which proposed interlocking the 
filtration with the target material. Upon further review, the agency 
concludes that requiring equipment to meet standards that ensure that 
the minimum filtration required in Sec. 1020.30(m)(1) is in the beam 
during each exposure is sufficient to ensure proper filtration and has 
deleted Sec. 900.12(b)(11)(ii) from the final regulation.
    m. Compression (Sec. 900.12(b)(8) (proposed Sec. 900.12(b)(12)))
    This paragraph proposed a number of requirements concerning the 
application of compression. The basic proposal was

[[Page 55916]]

that each mammography unit should have a compression device.
    (Comment 333). Five comments and several members of NMQAAC 
supported the proposed requirement. One comment suggested that FDA 
should go further and require the use of the compression device.
    If the compression device is present, most technologists will use 
it responsibly and also recognizes that the use of an item is difficult 
to enforce. FDA, therefore, has rejected this suggestion.
    Under Sec. 900.12(b)(12)(i) FDA proposed that, 5 years after 
publication, each system would be required to be equipped with an 
initial, foot controlled, power driven compression and also be required 
to allow the user to control additional ``fine adjustment'' of the 
compression. The proposal required that both controls be operable from 
each side of the patient.
    (Comment 334). Two comments stated that power-driven compression by 
foot control is unreasonable or unnecessary. One comment stated that 
FDA should delete the requirement for fine adjustment controls and the 
specifications on how the compression controls should operate because 
they will increase the cost of new equipment while providing little 
benefit. Another comment stated that no requirement beyond one that the 
system ``be capable of maintaining a force of 25 pounds for 15 seconds 
and have a maximum force no greater than 40 pounds when used in 
automatic or power driven mode'' is necessary.
    In contrast, twenty-eight comments agreed that ``automatic'' power 
driven compression should be required of all facilities but stated that 
it should be put in effect immediately, not 5 years from now, as 
proposed. Several of these comments expressed the opinion that the 
technologist needs to have both hands free to optimize the breast 
position. Five comments stated that manual and power compression 
controls, as called for, are essential for quality mammography. The 
comments further noted that manual controls are needed for finer 
adjustment and that the two controls complement each other, although 
one comment expressed the respondent's belief that the fine adjustment 
should be a manual control because that type of control was reassuring 
to some patients. One comment recommended that the reference to ``foot 
controls'' be deleted since the goal of ``hands-free'' application of 
compression may be achievable by some mechanism other than a foot 
operated control.
    FDA has accepted the last comment and modified the requirement 
accordingly. However, FDA believes that this ``hands free'' application 
of power compression and the fine adjustment control are basic to the 
delivery of quality mammography care and is retaining the requirements 
in the final regulations. FDA appreciates that this will have a cost 
impact on the installed base; however, the agency believes that the 
benefit to public health outweighs this cost and also notes that most 
of the current equipment can be brought into compliance with 
modifications that are far less costly than total replacement.
    (Comment 335). One comment suggested that FDA might wish to recast 
the proposal in terms of the desired outcomes, for example:
     Means of applying compression to the breast shall be provided 
that; (i) allow the technologist to use both hands to position the 
breast while applying compression, (ii) facilitate positioning from 
both sides of the patient without removing hands from the patient, 
(and) (iii) allow a slow, final adjustment of compression.
    While FDA appreciates this suggestion, the agency believes that 
such terms as ``allow'' and ``facilitate'' require too much subjective 
evaluation in the interpretation of compliance. Under some design and 
use conditions, certain technologists may be able to demonstrate that 
the equipment meets these requirements, while others may not. FDA 
believes that establishing reasonable standards for the equipment 
allows the majority of technologist the greatest opportunity to achieve 
optimal positioning for even the most challenging patients.
    (Comment 336). One comment stated that a number of different types 
of mammography systems in use either do not offer automatic compression 
or have only automatic compression with no manual compression knob. The 
comment suggested it would be worthwhile to retain maximum flexibility 
in the final regulation to allow evaluation of this type of retrofit 
system, so long as the intent and specifications of the final 
regulations were met. A second comment stated that the ``fine 
adjustment compression,'' as proposed, would place a costly burden on 
some facilities that do not have manual compression. Another comment 
indicated that when requiring all units to have a power driven 
compression paddle activated by foot controls, as proposed, it is also 
necessary to have a manual compression mode as well. One comment 
suggested that final compression should always be done using a hand 
control knob, which the technologist can easily control with direct 
tactile feedback. One comment agreed that it is necessary to have power 
driven compression, as proposed, but noted that it was not necessary 
that the fine adjustment control be power driven. One comment noted 
that the proposed requirements do not preclude the equipment from 
having a manual compression provision.
    Many of these comments resulted from misreading the proposed 
regulations. The proposal does not require the fine adjustment 
compression be a manual operation. The fine adjustment is usually a 
``manual'' adjustment in that it is applied by a hand operated 
(``manually operated'') control. This does not imply or require the 
provision of a direct linked drive dependent only on the input force 
provided by the operator. Many of the ``manual'' knobs are actually 
servo-driven power compression devices that are under a more closely 
controlled incremental advance than that provided by the foot control 
and, in these cases, the ``tactile'' feed-back sensed by the 
technologist is not necessarily related to the force applied to the 
patient. As the regulations are written, the design of the equipment 
can provide a truly ``manual'' control for the fine adjustment, or can 
provide a slower power driven application that may be adjusted by a 
hand control or other suitable means. FDA believes that most equipment 
with power-driven compression already provides a fine adjustment 
control and that the cost impact on those facilities not presently 
meeting this requirement will be outweighed by the advantages to 
positioning and improved image quality.
    (Comment 337). Five comments suggested that a requirement for 
maintaining compression for a specified period of time should be added 
and one suggested that this specification should be established for 
both automatic and fine adjustment compression.
    FDA proposed the criteria for application of compression without 
stating a specified time for maintaining the compression. This means 
that FDA expects the compression to meet the criteria in the 
regulations until the compression is terminated, either by an automatic 
release at the end of the exposure or by operator intervention during 
or after the exposure. Therefore, it is not necessary to expressly 
establish a time limit for maintenance of compression.
    NMQAAC discussed these provisions at some length and several 
committee members spoke about the importance of compression to the 
overall quality of

[[Page 55917]]

mammography. The committee recommended that the requirements for power 
driven and fine adjustment compression become effective immediately but 
that the requirements for the maximum force in the initial power drive 
remain a 5-year phase-in requirement. The agency considered the 
recommendation to move forward the effective date for the power driven 
and fine adjustment controls, but has determined that the cost 
considerations associated with accelerating the implementation of these 
requirements cannot be justified based on the expected improvements. 
Therefore, FDA has reworded these requirements to address some of the 
above comments, and has retained the effective date that was proposed.
    Section 900.12(b)(12(i)(C) proposed limits on the compression force 
required for the automatic power compression mode.
    (Comment 338). Two comments stated that the proposed requirement 
for 25 to 40 pounds under power driven compression was excessive and 
may result in patient injury.
    Based on input from NMQAAC, ACR, and the general comments provided 
by manufacturers, FDA believes that 25 to 45 pounds is an appropriate 
range and presents little risk of injury to patients when applied by 
trained technologists.
    (Comment 339). One comment observed that the proposal only limits 
the compression under power driven control and recommended that an 
upper limit be set for the maximum compression under manual control.
    Although FDA had considered such an upper limit, the idea was 
opposed by NMQAAC because they felt that it was unnecessary. FDA is not 
proposing such a limit at this time.
    (Comment 340). One respondent was concerned that there may be units 
designed to achieve the proposed compression forces but that have user 
adjustable controls that allow adjustment to values below the minimum 
proposed specification.
    FDA agrees that such equipment may exist or be introduced into the 
market place. The agency notes that under the regulations, as codified, 
the requirement is for values attainable by the user. If the user has 
direct control over any such system adjustment, then this adjustment 
must be used in testing the system. If such adjustment is only 
available through service or installation configuration, then the unit 
should be tested only to the limits adjustable by the operator. Under 
these circumstances, the respondent's concerns are adequately addressed 
because any user adjustable controls must be utilized in determining 
the compliance of the system with the standards. FDA has moved the 
requirement for the range of acceptable power driven compression to the 
quality assurance section under Sec. 900.12(e)(4)(iii).
    Under Sec. 900.12(b)(12(ii)(B), FDA proposed that each system have 
a means for manual compression release in the event of failure of other 
decompression mechanisms.
    (Comment 341). One comment questioned if the wording meant that 
compression must be maintained in the event of power failure and, if 
so, must the required display of override status also be maintained 
after power failure.
    FDA intends that the compression be maintained after a power 
interruption. However, the display of override need not continue in 
such circumstance because the fact that the patient is still under 
compression would serve as adequate indication that manual release is 
required.
    (Comment 342). One comment noted that there were many designs 
currently on the market that allowed for the manual release of the 
compression without the presence of a specific device as called for in 
Sec. 900.12(b)(12)(ii)(B). The comment requested that the proposal be 
reworded to emphasize the desired outcomes rather than a specific means 
of obtaining those outcomes.
    FDA believes that the wording in the proposal does address outcomes 
and does not intend the provision to require any specific release 
design. Any mechanism that allows the manual release of compression 
would meet the requirement. The requirements for the compression forces 
and decompression have been moved, as recommended by NMQAAC, to the 
quality assurance section of the regulations and are addressed in 
Sec. 900.12(e)(4)(iii) and (e)(5)(xi).
    In Sec. 900.12(b)(12)(iii)(A), FDA proposed that systems be 
equipped with different sized compression paddles matching the sizes of 
all full-sized image receptors provided and that compression paddles 
for special purposes, including those smaller than the full size of the 
image receptor (for 'spot compression') could be provided. FDA did not 
require that these special paddles be provided but included the 
reference to clarify that these paddles could be included in the system 
and are exempt from certain parts of the requirements applicable to the 
full size paddles.
    (Comment 343). Three comments supported the requirement in 
Sec. 900.12(b)(12)(iii)(A) as written. One comment recommended that the 
proposed requirement be expanded to require that facilities have the 
``spot compression paddles'' available. NMQAAC supported the proposal 
as published.
    FDA has done some minor rewording in this paragraph and renumbered 
it in the final regulations under Sec. 900.12(b)(8)(ii)(A).
    In Sec. 900.12(b)(12)(iii)(B), FDA proposed that the compression 
paddle be flat and parallel to the patient support and not deflect from 
parallel by more than 1.0 cm at any point when under compression.
    (Comment 344). Nine comments opposed the proposed requirement. 
Three of these suggested that this is not the best way to compress the 
breast because it ignores the anterior tissues and the often thicker 
tail of the breast. One comment stated that nonparallel paddles are 
useful for compression of very large breasts in the MLO view. Another 
comment noted that one manufacturer's equipment does not meet the 
proposed requirement, suggested that the subject does not need 
regulation, and recommended that the section be deleted. This comment 
maintained that the exemptions available for alternate devices would be 
``much too difficult to use to allow possible improvements.'' One 
comment responded to FDA's request for comments on the nonparallel 
``alternate design'' compression paddle by supporting the concept of 
allowing such a configuration under the proposed regulations. The 
comment further noted that some manufacturers are investigating the use 
of compression paddles that apply compression in nonparallel geometry 
and that these paddles would have difficulty complying with the 
regulation as proposed. One comment suggested that the proposed 
requirement was too restrictive, stating that several manufacturers 
have measured the paddle deflection on their units and found that the 
requirement may be difficult to meet on the 24 x 30 cm paddles. One 
comment suggested that the proposed specification could be improved if 
the tolerance were loosened, if the measured compression force were 
reduced, or if the allowable flex were expressed as a function of the 
applied force.
    Two comments asserted that the proposed regulation in 
Sec. 900.12(b)(12)(iii)(B) places too great an emphasis on the position 
of the compression paddle, but does not address the position of the 
film in the patient support. These comments recommended that the 
regulations

[[Page 55918]]

address the film location with respect to the edge of the patient 
support and relax the requirements for the compression plate. Three 
comments suggested that the description of the test method as proposed 
in Sec. 900.12(b)(12(iii)(B) should be deleted and that testing 
procedures should be left to the medical physicist to determine, or be 
included in a companion manual prepared by FDA. Fifteen comments 
neither supported nor objected to the proposed requirement, but were 
concerned with the test procedure as proposed and suggested 
modifications or requested clarification of the procedure.
    NMQAAC discussed this section at some length. Some members and 
consultants were concerned that the specifications in the proposal 
would limit the introduction of new equipment and, even though the 
regulations provide procedures for obtaining approval for alternate 
standards, wanted to modify the requirement. Experts on the committee 
stressed that the purpose of this regulation was to eliminate those 
worn and faulty compression devices that were intended to be flat and 
parallel by design but which, through use, now flex unacceptably. After 
consideration, the committee recommended that the requirement remain 
but that a new provision be added that addressed those paddles that by 
design were not intended to remain straight and parallel under 
compression. They also recommended that the test procedure described in 
this section be deleted as a requirement because it could be determined 
by the physicist during the survey.
    In response to the public comments and NMQAAC recommendations, FDA 
has made changes as outlined below. FDA is deleting the provision that 
established a test procedure for this section. The requirements have 
been modified and renumbered as Sec. 900.12(b)(8)(ii)(B) and a new 
Sec. 900.12(b)(8)(ii)(C) requires that all paddles intended by the 
manufacturer's design not to be flat and parallel under compression 
must meet the manufacturer's design specification and maintenance 
requirements. The agency will revisit and modify its proposal for the 
test procedure for this section in the future and all comments 
regarding the procedure will be considered again in that process.
    Under Sec. 900.12(b)(12)(iii)(C) and (D), FDA proposed that the 
chest wall edge of the compression paddle should be straight and 
parallel to the edge of the image receptor and that the chest wall edge 
of the compression paddle should not interfere with the chest wall edge 
of the image.
    (Comment 345). Two comments requested clarification on how straight 
and how parallel the requirement intended the chest wall edge of the 
paddle to be. One comment agreed with the intent of the proposed 
regulation, but expressed concern that varying interpretations of the 
written regulation will lead to confusion in enforcement. This comment 
recommended that, if such specifications are included in the final 
regulations, there should be some tolerance specified that is both 
affordable and effective in the improvement of mammography.
    FDA notes that the intent of this section is to eliminate the older 
style compression paddle that had a curved chest wall edge. The agency 
believes that the words straight and parallel are well understood but 
will address concerns raised by the comments through issuance of a 
guidance on this paragraph that contains a test procedure facilities 
may utilize. The description of this procedure should also clarify any 
confusion regarding FDA's interpretation of the regulation.
    In Sec. 900.12(b)(12)(iii)(D), FDA had proposed that the chest wall 
edge of the compression paddle should be bent upward.
    (Comment 346). One comment recommended that the proposed regulation 
include a requirement that the chest wall edge of the paddle be 
perpendicular to the surface of the compression plate. Another comment 
stated that the use of ``should'' in Sec. 900.12(b)(12(iii)(D) has 
little meaning and is unenforceable.
    NMQAAC discussed both paragraphs and did not recommend any changes. 
FDA notes that this provision was not intended to establish a mandatory 
requirement but to clarify that such a design, intended to enhance 
patient comfort, was permissible. This requirement has been codified 
under Sec. 900.12(b)(8)(ii)(E) in the final regulations. The word 
``should'' has been replaced with ``may'' in the final rule. FDA does 
not agree that it is advisable to require the chest wall edge to be 
perpendicular to the surface of the compression paddle since this could 
lead to sharp edges that might cause patient discomfort.
    Under Sec. 900.12(b)(12)(iv)(A), FDA proposed that, 5 years after 
the publication date of the final regulations, the edge of the 
compression paddle shall align with the chest wall edge of the image 
receptor to within 1 percent. Proposed Sec. 900.12(b)(12)(iv)(B) 
further restricted the alignment to within 2 millimeters 10 years after 
publication and Sec. 900.12(b)(12)(iv)(C) proposed a test procedure for 
the requirement.
    NMQAAC recommended that the Sec. 900.12(e)(12)(iv)(A) be moved to 
the QC section of the final regulations and that the requirements 
should go into effect at the earliest opportunity. NMQAAC also 
recommended that the requirement under Sec. 900.12(b)(12)(iv)(B) and 
(C) be deleted because the committee believed the proposed 2-millimeter 
requirement was too stringent. The proposed 2-millimeter requirement 
and the test procedure have been deleted and the final regulation 
regarding compression paddle-image receptor alignment was moved to the 
quality assurance section and is codified under 
Sec. 900.12(e)(5)(vii)(C) where it will become effective at the 
earliest effective date.
    (Comment 347). One comment recommended caution in specifying these 
alignment requirements because they might limit design in some areas of 
new technology. The comment recognized that these proposed 
specifications are only applicable to film-screen systems, but 
expressed concern that the concepts might carry over into new 
technology areas.
    FDA assumes that this comment was directed toward the issue of 
image receptor size for digital systems, but does not anticipate any 
conflict.
    (Comment 348). Eleven comments agreed with tightening the tolerance 
for alignment as proposed in Sec. 900.12(b)(12)(iv) but suggested that 
only a positive misalignment should be allowed.
     FDA agrees and accepts these comments.
    (Comment 349). Eight comments noted a typographical error in 
Sec. 900.12(b)(12)(iv)(A). FDA has corrected this.
    (Comment 350). Three comments recommended that the ``October 1, 
2000'' effective date be deleted and that the requirement go into 
effect in the earliest phase because, in the respondents' opinions, the 
vast majority of systems already meet this requirement.
    FDA agrees with these comments and has accepted this recommendation 
to move the effective date forward.
    (Comment 351). Six comments expressed concern regarding the test 
for this paragraph.
    These comments will be reconsidered when FDA publishes its 
guidelines for the QC test.
    Under Sec. 900.12(b)(12)(iv)(D), FDA proposed that the alignment 
criteria for the contact mode should also be applicable to the 
magnification mode 10 years after the publication of the final 
regulations and proposed a test procedure.

[[Page 55919]]

    (Comment 352). Five comments suggested that the requirement was 
unnecessarily restrictive and should be dropped. Four comments 
supported the proposed requirement, believing it serves to ensure the 
accuracy of the alignment of the edge of the compression paddle with 
the edge of the image receptor. One comment recommended a rewording for 
the requirement. Two respondents expressed concern regarding the test 
procedure. NMQAAC suggested that the requirement in the magnification 
mode was unnecessary and should be deleted.
    After reviewing the comments, FDA has accepted the NMQAAC 
recommendation and deleted the requirement for paddle alignment in the 
magnification mode.
    Under Sec. 900.12(b)(12)(v), FDA proposed that, 5 years after 
publication of the final regulations, all systems should display the 
compressed breast thickness. The proposal also established a test 
procedure for the requirement.
    (Comment 353). One comment pointed out that current indicators of 
compressed breast thickness are grossly inaccurate for a number of 
reasons, including paddle and compression arm flex, lack of uniformity 
across the breast, and differences in the location at which various 
manufacturers determine the breast thickness (since there is no 
agreement where the breast thickness is to be measured). Two comments 
recommended that the word ``correct'' be inserted between ``the'' and 
``compressed'' in Sec. 900.12(b)(12)(v). One manufacturer requested an 
exception for its product because the measured breast thickness read 
out could be off by 0.6 to 1.0 cm for their paddle. One comment 
expressed concern that there was no clear specification to the accuracy 
of the indicated value proposed in Sec. 900.12(b)(12)(v)(A). NMQAAC 
discussed this provision at its April 1996 meeting and recommended that 
the requirement for a display remain but that no accuracy specification 
be associated with the display. NMQAAC revisited the issue at its 
January 1997 meeting but did not change its recommendation. Another 
comment suggested that the proposed requirement should apply only to 
equipment that uses the compressed breast thickness in an algorithm to 
determine technique factors. One comment supported the proposed 
requirement in Sec. 900.12(b)(12)(v)(A) because it is especially 
important for implant patients, but recommended that it go into effect 
5 years after the effective date of the regulations rather than 10 
years after, as proposed.
    FDA has reviewed the comments and reassessed the need for this 
requirement. The practical application of the information provided by 
the display to the mammography process appears to be questionable and 
the concept of having a display that has no associated accuracy is of 
debatable value. FDA has decided to remove Sec. 900.12(b)(12)(v) from 
the final regulations in accordance with the agency's desire to 
minimize costs, as discussed previously. All comments requesting 
clarification or suggesting modification to the test procedure will be 
considered again if FDA revisits this requirement.
    The portions of proposed Sec. 900.12(b)(12) that have been retained 
in the equipment provisions were codified under Sec. 900.12(b)(8).
    n. Technique factor selection and display (Sec. 900.12(b)(9) 
(proposed Sec. 900.12(b)(13)))
    In this paragraph, FDA proposed requirements for the selection and 
display of technique factors.
    FDA proposed in Sec. 900.12(b)(13)(i) that every system shall have 
the capability for manual selection of mA's or, at least, of mA or 
time. No public comments addressed this issue. NMQAAC discussed the 
proposal at both the April 1996 and the January 1997 meeting and 
supported the proposal. FDA reworded the requirement slightly before 
codification to clarify its intent. Because of the deletion of 
paragraphs listed earlier in the proposal, paragraph Sec. 900.12(b)(13) 
has been codified as Sec. 900.12(b)(9), and this paragraph became 
Sec. 900.12(b)(9)(i) in the final rule.
    Under Sec. 900.12(b)(13)(ii), FDA proposed that all technique 
factors be clearly displayed at the control panel prior to exposure. At 
Sec. 900.12(b)(13)(iii), the agency proposed that such factors be 
preindicated in the AEC mode.
    (Comment 354). One comment recommended FDA clarify that the 
specification in Sec. 900.12(b)(13)(ii) applies only to the manual mode 
of operation. A comment on Sec. 900.12(b)(13)(iii) requested 
clarification of which technique factors were intended to be covered by 
this requirement. At its April 1996 meeting, NMQAAC also expressed some 
confusion regarding the same issue. Another comment recommended that 
the requirements of Sec. 900.12(b)(13)(iii) and (iv) be combined.
    FDA believes that requirements for preindication and postindication 
of the technique factors should be presented under separate paragraphs 
and has not accepted this last comment. FDA did clarify 
Sec. 900.12(b)(13)(ii) and (iii) and combined them into a single 
provision at Sec. 900.12(b)(9)(ii).
    Under Sec. 900.12(b)(13)(iv), FDA proposed that, after AEC 
exposure, the system should indicate the actual kV and mA's used during 
the exposure.
    (Comment 355). Two comments recommended that this requirement be 
deleted or its implementation date be delayed because the replacement 
or retrofit of many older units might be costly. Another comment stated 
that a mA's readout, as proposed in Sec. 900.12(b)(13)(iv), has not 
been proven necessary. NMQAAC discussed this issue and the cost 
concerns related to retrofits to provide the postexposure mA's 
indication. The committee supported the requirement but requested some 
wording changes to clarify the meaning of mA's indication.
    FDA has retained this provision because it concluded that the costs 
associated with the possible retrofits are not significant enough to 
outweigh the benefits and has included it in the final regulations 
under Sec. 900.12(b)(9)(iii).
    Under Sec. 900.12(b)(13)(v), FDA had proposed that each unit 
provide an indication of kVp that was accurate to within + 5.0 percent 
of the actual kVp.
    (Comment 356). Five comments agreed with the proposed five percent 
accuracy specification, but another comment suggested that the 
requirement for kVp accuracy of + 5.0 percent was not justified because 
there was no definition of what kVp really means and no calibration 
available for kVp meters. Another comment stated that ``5 percent of 
the actual kVp as proposed in (b)(13)(v), is a very large 
discrepancy,'' noting that 5 percent of 30 kVp allows 31.5 kVp, which, 
in the respondent's opinion, presently is considered to be 
unacceptable. The comment further suggested that Sec. 900.12(b)(13)(v) 
be changed to read: ``All indications of kVp shall be within 1 kV of 
the actual kVp.''
    In Sec. 1020.30 FDA defines kVp to mean the maximum value of the 
potential difference across the X-ray tube during an exposure. FDA 
agrees with the comment that the + 5.0 percent accuracy is a large 
discrepancy and notes that it is the same specification currently 
established by the most recent revision of the ACR manuals. The agency 
intends to provide additional information regarding compliance with 
this requirement.
    (Comment 357). Three comments, including one from NMQAAC, noted 
that there was a conflict between the kVp accuracy specification at 
Sec. 900.12(b)(13)(v) and at Sec. 900.12(e)(5)(ii)(A). NMQAAC also 
recommended that the requirement be moved to the quality assurance 
section

[[Page 55920]]

and that the + 5.0 percent accuracy specification be retained. FDA has 
accepted these recommendation and the requirement now appears in the 
final regulations under Sec. 900.12(e)(5)(ii) and includes the + 5 
percent accuracy specification.
    In Sec. 900.12(b)(13)(vi), FDA proposed that, 10 years after the 
publication of the final regulations, each X-ray unit used for 
mammography would be required to have a specific range of kVp and mA's 
selection and that adjacent selections of the kV selection and adjacent 
selections of the mA's should not vary by more than a prescribed 
amount. The public comments regarding this section were overwhelmingly 
against including these proposals in the final regulations. NMQAAC 
supported the proposals but only marginally so, with many opposing 
opinions. FDA has reconsidered the advisability of including these 
specifications in the final regulations, based in part on the public 
comments and in part on the difficulty in predicting the necessity for 
these limitations 10 years in the future and has deleted all 
requirements proposed under Sec. 900.12(b)(13)(vi) from the final 
regulations.
    o. Radiation output (proposed Sec. 900.12(b)(14)) 
    This paragraph proposed setting a minimum value for radiation 
output per second of mammography X-ray equipment, with an increase in 
that minimum value to occur 5 years after publication. This section has 
been codified in the quality assurance section of the final 
regulations.
    (Comment 358). Two comments agreed with the requirement proposed in 
Sec. 900.12(b)(14)(i), with one urging that the requirement be fully 
implemented at the earliest possible date rather than being phased-in. 
One comment suggested that the proposed requirements in 
Sec. 900.12(b)(14)(i) and (ii) might actually be in conflict with each 
other. FDA reviewed these provisions and does not see a conflict 
because clause (i) specified an exposure rate and (ii) specified a time 
over which that rate must be met. However, in response to other 
concerns, as outlined in the preamble to the quality assurance section, 
FDA has modified the requirement to clarify that the specification is 
to be an average over three seconds and not an instantaneous rate 
measurement.
    (Comment 359). One comment suggested that the proposed requirement 
in paragraph (b)(14)(i) be replaced by the equivalent air kerma 
expressed in milligray (mGy). The guidelines followed by FDA in the 
writing of regulations specify that all numerical limits, where 
applicable, be expressed in terms of the International System (SI) of 
Units, the internationally accepted standard, followed by the more 
common equivalent in parentheses.
     In the proposed regulations, FDA had represented radiation limits 
in terms of exposure expressed in the SI unit of coulomb per kilogram 
(C/kg). Although C/kg is the correct SI unit for exposure, it is an 
awkward unit for the actual operating ranges of exposure (10-4 C/kg) of 
mammography systems. FDA believes now that it would be more 
advantageous to specify radiation limits in terms of the alternate 
quantity air kerma expressed in the SI base unit of gray (Gy). Air 
kerma, which is defined at Sec. 900.2(d), is the sum (per unit mass of 
air) of the initial kinetic energies of all the charged ionizing 
particles liberated by the X-rays. At the X-ray energies typically used 
in diagnostic radiology and mammography, values for air kerma are 
practically indistinguishable from values of absorbed dose in air. Air 
kerma is increasingly accepted in the international community as the 
quantity preferred in the specification of radiation delivered, and it 
is being proposed to replace exposure in amendments in 21 CFR part 
1020. Because amendments to those standards are not final, the units 
were not used in the proposal. However, FDA is replacing the quantity 
exposure with the quantity air kerma in these final MQSA regulations 
because it anticipates that parallel changes will be made in the 
international standards and part 1020.
    (Comment 360). One comment suggested that FDA recast proposed 
Sec. 900.12(b)(14)(i) as a performance objective, such as: ``The 
radiation output, in terms of exposure rate, at clinically useful kVp's 
shall be sufficiently high to avoid exposure times of such duration 
that loss of resolution due to motion or excessive dose due to film 
reciprocity failure is expected to occur.''
    FDA appreciates the benefits of adopting performance standards when 
appropriate but believes that in this case the suggested wording 
introduces an unacceptable level of subjectivity into determining 
compliance.
    (Comment 361). One comment recommended that the test procedure 
proposed to measure radiation output in Sec. 900.12(b)(14)(iii) specify 
the position of the compression paddle during the measurement.
    FDA assumes this comment is expressing concern regarding the 
scatter contribution to the reading and its variability depending on 
the distance the paddle is located from the detector. FDA recognizes 
the possible effects of scatter on this measurement but does not 
believe the contribution is of sufficient concern to warrant the 
prescription of paddle position relative to the detector. In clinical 
use, the paddle is obviously in contact with the breast. If a facility 
wishes to test with the paddle in a similar position, FDA has no 
objection. Similarly, if the paddle is moved nearer to the focal spot, 
FDA would find this acceptable. FDA does, however, require the 
compression paddle to be in the X-ray beam between the source and the 
detector as was specified in Sec. 900.12(b)(14)(iii).
    (Comment 362). One comment suggested that FDA require that 
compliance with Sec. 900.12(b)(14) be determined ``with the phantom in 
the beam and that the exposure be completed within 2.5 seconds.''
    FDA believes that placing any phantom in the beam during this test 
would not improve this test and that the three second exposure proposed 
is both reasonable and appropriate for this requirement.
    (Comment 363). Two comments suggested that compliance with 
Sec. 900.12(b)(14)(i) should be determined at a routine clinical kVp 
instead of the proposed 28 kVp. FDA notes that 28 kVp is used 
clinically for mammography, although not as frequently as other kVp 
values. It was selected first by the American Association of Physicists 
in Medicine and then by the ACR/CDC Imaging System Focus Group as the 
standard kVp to be used in association with their radiation output 
specifications. These specifications were utilized by FDA in 
establishing this radiation output requirement. If a different kVp were 
selected, the radiation output would likely have to be modified; 
however, professional consensus on what modifications would be 
appropriate is presently lacking. The agency, therefore, does not 
accept these comments.
    (Comment 364). One comment recommended that the proposed 
requirements under Sec. 900.12(b)(14) should be made part of 
Sec. 1020.31 so that uniform requirements would be ensured nationwide. 
FDA reiterates its previous position that this would not achieve the 
desired impact on the installed base of mammography equipment. FDA 
believes that most modern mammography systems can meet this 
requirement. However, the agency is considering parallel requirements 
under Sec. 1020.31 to ensure that future production is compliant.
    (Comment 365). One comment supported the test procedure specified 
in Sec. 900.12(b)(14)(iii) as being an

[[Page 55921]]

improvement over the current specification. Another comment suggested 
that the requirement in Sec. 900.12(b)(14)(i), as written, should only 
apply to a molybdenum/molybdenum Mo/Mo anode/filter combination because 
other target-filter combinations may not need to meet the requirement 
to deliver adequate imaging.
    NMQAAC supported the proposed requirements, but suggested that the 
specifications should be limited to Mo/Mo target-filter units only. 
They also recommended that all of Sec. 900.12(b)(14) be moved to the 
quality assurance section.
    FDA has accepted NMQAAC recommendations to limit the requirements 
to Mo/Mo target-filter units and to codify the requirement with the QC 
requirements.
    (Comment 366). One comment noted that xeromammography equipment 
might not meet these proposed requirements.
    FDA believes that xeromammography units should be able to meet the 
requirement, as proposed, but with the acceptance of the Mo/Mo 
limitation discussed above, the requirement would no longer be 
applicable to xerox systems, which incorporate tungsten targets.
    (Comment 367). One comment suggested that the proposed requirements 
of Sec. 900.12(b)(14)(i) and (iii) need to be linked in order to 
explain where the output is to be measured.
    FDA does not agree with this comment although it has reworded the 
proposed Sec. 900.12(b)(14) for clarification. The provision has been 
codified as Sec. 900.12(e)(5)(x).
    p. Automatic exposure control (Sec. 900.12(b)(10) (proposed 
Sec. 900.12(b)(15)))
    As proposed, this paragraph required that each mammography system 
have an automatic exposure control (AEC) for mA's, established a 
specification for the AEC reproducibility, and set requirements for the 
indication of the AEC detector positions and selected location.
    (Comment 368). One comment suggested that the requirements proposed 
in Sec. 900.12(b)(15) should be prefaced with a statement that they are 
intended to apply only to film-screen modalities. A related comment 
reported that xeromammography systems do not have AEC controls as 
required in Sec. 900.12(b)(15) and that this would bar their use.
    FDA agrees with these comments and has rewritten this requirement 
to limit it to screen-film mammography systems.
    Under Sec. 900.12(b)(15)(i), the proposal required all AEC devices 
to be operable in each equipment configuration provided and gave 
examples of common configurations.
    (Comment 369). Several comments sought to limit the applicability 
of this requirement in different ways. One comment supported the 
proposed requirements in Sec. 900.12(b)(15)(iv)(A) and (B) as a means 
to ensure appropriate detector location and thereby avoid repeat 
exposures and reduce patient dose. One respondent did not believe that 
the automatic exposure control photo-timing proposed in 
Sec. 900.12(b)(15)(i) is significant in obtaining satisfactory 
diagnostic mammograms. Three comments recommended modifying 
Sec. 900.12(b)(15)(i) by replacing ``of equipment configuration 
provided'' with ``where applicable.'' The comments further suggested 
that the examples of equipment configurations in Sec. 900.12(b)(15)(i) 
be deleted. One comment agreed with the April 1996 NMQAAC 
recommendation that the requirements proposed in Sec. 900.12(b)(15)(i) 
should be limited to clinically used configurations.
    FDA remains convinced that the use of AEC devices on mammography 
equipment is an aid to quality mammography and believes that requiring 
it for ``all combinations of equipment configuration provided'' is 
appropriate and necessary. The agency notes that the requirement 
applies to the configuration of the individual unit. For example, if 
the unit is not provided with magnification capability, then it would 
not be required to have a functioning AEC in a nonexistent 
magnification mode. The agency also notes that NMQAAC reversed its 
April 1996 position during its January 1997 meeting and concurred with 
the requirement as proposed.
    Under Sec. 900.12(b)(15)(ii), FDA proposed that the AEC be capable 
of providing automatic mA's selection.
    (Comment 370). One comment recommended deleting this requirement, 
stating ``that it is the purpose of AEC to provide automatic mA's 
selection'' and, therefore, the requirement was redundant. One comment 
requested clarification of the phrase ``automatic mA's selection.'' 
Another comment asked whether Sec. 900.12(b)(15)(ii) required automatic 
termination of exposure or automatic display of mA's and questioned why 
the AEC should be able to automatically select mA's.
    FDA defines an automatic exposure control as a device that 
automatically controls one or more technique factors in order to obtain 
a desired quantity of radiation at a preselected location. Such a 
device would automatically terminate the exposure when the selected 
quantity of radiation had been delivered. This definition does not 
restrict the technique factor(s) that may be selected; the control of 
target material, focal spot, filtration, time, mA, and/or kVp are all 
viable options for such a device. Because the mA's is the product of 
time (in seconds) and mA, the control of time and/or mA represents 
control of the mA's; therefore, AEC's generally function by controlling 
mA's and/or kVp. FDA was initially concerned that an AEC that 
controlled kVp alone, without capability to control mA's, could not 
adequately ensure the small incremental changes in radiation that are 
often necessary in mammography. FDA has reconsidered this position 
because it has concluded that any such device that reaches the 
marketplace would provide the necessary ranges of adjustment in order 
to have been approved under the FDCA's requirements for safety and 
efficacy of new devices. Therefore, FDA is removing the requirement 
proposed in Sec. 900.12(b)(15)(ii) that all AEC devices provide 
automatic mA's selection.
    Under Sec. 900.12(b)(15)(iii), FDA proposed a limit on the 
reproducibility of the AEC.
    (Comment 371). One comment suggested the wording be changed to 
include ``for each target/filter combination.''
    FDA believes the change is not needed; because no target-filter 
combinations were specified in the regulation, all combinations are 
subject to the requirement.
    NMQAAC recommended that this requirement be moved to the quality 
assurance section. FDA has accepted this recommendation and the 
specification for the evaluation of the AEC reproducibility is codified 
in Sec. 900.12(e)(5)(i).
    Under Sec. 900.12(b)(15)(iv), FDA proposed requirements regarding 
the positioning flexibility of the AEC detector, visual location of the 
available detector positions, and indication of which AEC detector 
location was selected.
    (Comment 372). Two comments recommended that the proposal be 
expanded to require increased flexibility in placement of the AEC 
detector. One comment commended the proposed requirement for AEC 
positions to be indicated at the input surface of the breast 
compression paddle. The comment believed that this requirement would 
improve the quality of imaging and prevent repeat images. Two

[[Page 55922]]

comments suggested that FDA add a requirement specifying the necessary 
accuracy of the indication of both the size and available position of 
the AEC detectors. The respondents' suggested the indication might 
depend on magnification of the indication resulting from various breast 
thicknesses.
    FDA interprets these comments to mean that a projected indication 
on the input surface of the breast might vary in size and location 
depending on the magnification induced by the displacement of the input 
surface caused by various breast thicknesses. FDA agrees that this 
might occur and notes that such a system would be a design that might 
not be able to meet the requirements.
    FDA intends the indications of the size and location represented on 
the compression paddle to be representative of the actual size and 
location of the detectors as they would appear if marked on the breast 
support device. The agency anticipates no confusion will be caused by 
varying displacement of the paddle from the patient support since the 
indication of size and position will remain constant.
    (Comment 373). One comment suggested that the indicators should not 
``give rise to artifacts in the image.''
    FDA believes that any such artifacts will be detected and corrected 
during the normal QC process and, therefore, modification of this 
requirement is unnecessary.
    (Comment 374). One comment stated that this requirement leaves too 
much room for interpretation and would be very difficult to inspect 
against. The comment suggested one could argue that merely knowing the 
position via the handle that moves the detector would be adequate for 
proper detector positioning. The comment further stated that all 
current units do provide clear indication of detector position, which 
is visible from both sides of the patient, and that the requirement 
should be removed.
    FDA does not agree that the requirement is subject to conflicting 
interpretation or would be difficult to inspect, but does agree that 
the location of the position selector would be an adequate indication 
of which detector position had been selected (although it would not 
indicate the detector position itself). FDA also does not agree that 
the installed base of systems all provide such flexibility or 
indications and remains persuaded that the requirement will provide 
useful tools for the technologist.
    NMQAAC recommended that FDA delete the proposal that the selected 
detector position be visible from both sides of the patient because 
they did not consider it of sufficient importance to require in the 
regulations. FDA has adopted this recommendation and the requirement 
has been amended accordingly.
    Under Sec. 900.12(b)(15)(v), FDA proposed that the operator be able 
to vary the optical density from the normal density setting. No 
specific comments were received on this proposal and FDA codified this 
requirement without change.
    Under Sec. 900.12(b)(15)(vi), FDA proposed that, 10 years after the 
publication of the final regulations, each unit would be required to 
provide four steps above and four steps below the normal optical 
density setting and proposed limits for the acceptable variability 
between adjacent settings on this control.
     (Comment 375). FDA received a large number of comments on this 
section. The overwhelming majority were opposed to the requirement 
because of concerns regarding the wording of the provision, the 
perceived cost to facilities, the range of control to be provided, the 
incremental difference between adjacent settings, and the necessity for 
the requirement. In response to these comments and because of agency 
concerns regarding costs, FDA concluded that the proposal should be 
deleted from the final regulations and that further study should be 
undertaken to determine if future requirements in this area are 
warranted. If regulations or guidelines are proposed later, the 
individual comments will be reconsidered at that time.
    Under Sec. 900.12(b)(15)(vii), FDA proposed requirements for the 
optical density variation permitted with a screen-film mammography 
system under AEC.
    (Comment 376). Three comments supported the proposed requirement in 
paragraph (b)(15)(vii) because it evaluates the equipment performance 
when used on breasts of various size and density. Two comments 
indicated that Sec. 900.12(b)(15)(vii) was not stringent enough and one 
of these recommended that an initial value of 0.15 OD should be 
specified.
    FDA disagrees with this comment because it believes that the 
initial value should remain the same as that used in the interim 
regulations. NMQAAC recommended that these requirements be moved to the 
quality assurance section and FDA agreed. The requirements have been 
codified under Sec. 900.12(e)(5)(i).
    In the proposal, FDA had specified that the system meet the 
requirements for AEC reproducibility at each available detector 
position.
    (Comment 377). Three comments suggested that the test under 
Sec. 900.12(b)(15)(vii) is necessary for only one detector position 
because the detector and associated electronics do not change.
    FDA disagrees with these comments because some AEC detectors 
utilize individual detectors that are permanently fixed in position. 
The switching of position is actually a change in contact points or 
system logic to read the selected position. In such cases, the testing 
of one position provides no indication of the function at other 
locations.
    (Comment 378). One comment suggested that the testing of photo-
timer tracking with dosimeter positioning is usually not necessary 
unless multiple detectors are used.
    The agency believes that when the process is accomplished by the 
relocation of the same detector to different positions, the functioning 
of the detector at each detector location is not guaranteed by testing 
at only one position. This could be influenced by broken wires, poor 
connections, or dirty contacts in the system.
    (Comment 379). One comment stated that testing of the AEC at all 
detector positions will be dependent on the dimensions of the phantom. 
The respondent stated that the commonly used 10 cm x 10 cm phantom may 
not be large enough for all positions and that this will drastically 
increase the time required to perform this test.
    FDA does not agree with this comment. The phantom could be placed 
near the focal spot and thereby cover all available detector positions 
without being repositioned.
    (Comment 380). One comment suggested that with multiple detectors 
it is not necessary to test the tracking over the entire range of 
phantom thicknesses.
    FDA interprets this comment to mean that, once the detector 
reproducibility at each position has been established, the testing of 
reproducibility for additional thickness need be performed at only one 
position. FDA does not agree with this comment; it does agree, however, 
that when one detector is used and moved from position to position, 
once it is established that the detector is reproducible over the 
entire range of thicknesses at one position, it is only necessary to 
establish the correct functioning for one thickness at each other 
position. In response to these comments and in recognition of the costs 
associated with testing reproducibility at multiple positions, FDA has 
deleted the specification for

[[Page 55923]]

testing at each detector position. Because the agency remains convinced 
that the best way to ensure that the detector(s) functions properly at 
each position is to test it/them at each position. FDA encourages 
facilities and the medical physicists to include such testing as a 
routine part of the annual survey. The remaining provisions of proposed 
Sec. 900.12(b)(15) are codified as Sec. 900.12(b)(10).
    q. Disabled examinees (proposed Sec. 900.12(b)(16))
    In this paragraph, FDA proposed that each facility choosing to 
schedule disabled patients have equipment and protocols in place to 
ensure that the facility could adequately accommodate such disabled 
patients. This proposal did not require each facility to accept 
disabled patients, but did require those doing so to be capable of 
performing the service.
    (Comment 381-382). Many comments expressed the mistaken belief that 
FDA was seeking enforcement powers under the American with Disabilities 
Act (ADA) or to duplicate the ADA.
    Other comments on this section ranged from calling the requirement 
too lenient to calling it unnecessarily intrusive. The majority of the 
comments, although not opposed to accommodating disabled patients, were 
concerned that the screening of patients prior to their examination 
would be difficult or impossible because many appointments are not made 
by the patient. Comments also expressed concern that accepting disabled 
patients under this requirement would obligate facilities to be able to 
accommodate all disabled patients. Some comments also questioned 
whether there was equipment available that could offer this range of 
use.
    Another area of concern was related to mobile units and facilities 
which, because of their size and stand-alone nature, would be difficult 
to adapt to accommodate the range of disabilities the facilities might 
encounter. NMQAAC consumer representatives supported this section and 
urged FDA to require facilities to either serve disabled patients or 
refer them to a facility that can. Other comments questioned the value 
of referrals, citing lack of knowledge regarding other facilities' 
equipment, staff, and ability to deliver the services necessary.
    Because of the lack of consensus on the need for this requirement 
and the concerns raised in the comments, FDA has decided to delete the 
proposed requirement and revisit it at a future date if a problem is 
perceived. FDA strongly urges facilities to voluntarily institute 
procedures that will direct patients with disabilities to facilities 
that are capable of serving this population. The agency believes that 
local consumer groups and all accreditation bodies can pool information 
and educate the public and the mammography community about the 
availability and locations of such services.
    r. X-ray film (Sec. 900.12(b)(11) (proposed Sec. 900.12(b)(17)))
    In this paragraph, FDA proposed a requirement that X-ray film used 
for mammography must be designated for such use by the film 
manufacturer.
    (Comment 383). One comment supported the proposed requirement. 
Three comments suggested that it was too vague, one comment questioned 
how one would know if a manufacturer's designated mammography film is 
adequate for doing quality mammography under the requirements, and 
another suggested the adoption of the storage recommendations from 
ACR's Recommended Specifications for New Mammography Equipment. NMQAAC 
supported this requirement as proposed.
    FDA has not proposed regulations governing film storage because it 
believes that each facility should follow the manufacturer's 
instructions for the particular film being used. The goal of this 
requirement is to ensure that the film used by the facility is 
considered, at least by the manufacturer, as being suitable for 
mammographic use. The regulation is not intended to establish standards 
for film; the only requirement placed on the facility is to check that 
the film it uses has been designated by the manufacturer for 
mammography. The requirement is not vague once its limited scope is 
understood. FDA codified this requirement, without change, in 
Sec. 900.12(b)(11).
    s. Intensifying screens (Sec. 900.12(b)(12) (proposed 
Sec. 900.12(b)(18)))
    FDA proposed in this paragraph that only intensifying screens that 
have been specified by the manufacturer as appropriate for mammography 
may be used for mammography.
    (Comment 384). One comment supported the proposed requirement. 
Again, one comment questioned how a facility would know if a 
manufacturer's designated mammography screens are adequate for doing 
quality mammography under the proposal. Another comment stated that 
xeromammography systems do not use intensifying screens and that 
Sec. 900.12(b)(18) would serve to ban their use.
    FDA does not intend a specification about screen requirements to 
apply to any modality that does not use screens in the production of 
its images. Therefore, the agency sees no impact of this requirement on 
xeromammography. Although NMQAAC supported the requirement, one member 
expressed concern that the wording of the proposal implied that the 
facility was responsible for matching the spectral sensitivity of the 
film and the screen. As explained in connection with the mammography 
film specification above, the intent of the requirement is not to 
address the quality of the product, but rather to ensure that it is one 
intended by the manufacturer to apply to mammography. In general, the 
facility is responsible for matching the spectral sensitivities of the 
screen with the film. However, the facility is expected to use the 
information provided by the manufacturers and not to derive the 
information independently. FDA has reworded the requirement to clarify 
this point and codified it as Sec. 900.12(b)(12).
    t. Film processing solutions (Sec. 900.12(b)(13) (proposed 
Sec. 900.12(b)(19)))
    In this paragraph, FDA proposed that facilities use film processing 
solutions capable of developing films in a manner equivalent to the 
film manufacturer's minimum specifications.
    (Comment 385). Three comments supported this proposed requirement 
and requested that guidance documents be established for this area. Six 
comments suggested that the word ``minimum'' be deleted because, in the 
respondents' opinions, most facilities generally comply with the 
regulatory requirement and the regulation should encourage them to meet 
more than the minimum. FDA appreciates these comments and notes that 
facilities are free to exceed this minimum; the requirement, however, 
is intended only to establish that facilities comply with the 
manufacturers' minimum standards.
    (Comment 386). Three comments questioned how a facility could 
demonstrate equivalence under Sec. 900.12(b)(19) because some 
manufacturers of film processing chemicals refuse to acknowledge that 
other vendors' chemicals produce ``equivalent'' results. The comments 
requested that the wording be changed to clarify compliance.
    FDA believes these comments are similar to the ones regarding 
quality of the film and screens used in mammography. It is not the 
intent of the requirement that the facility experimentally determine 
the compatibility of various solutions with the film, but only that the 
facility obtain documentation from the suppliers showing that their 
products are intended to be used for processing the

[[Page 55924]]

particular film used by the facility and that they provide results 
consistent with the film manufacturer's specifications. The facility 
would only be required to establish the equivalence independently if no 
documentation, in the form of labeling or specifications, were 
available from the chemical or film supplier.
    (Comment 387). One comment questioned how the requirement can be 
met when the film manufacturer does not manufacture chemicals for film 
processing.
    FDA notes that, in such cases, it would likely be easier to 
establish equivalence because the film manufacturer would specify the 
requirements for the processing as opposed to a manufacturer that 
supplies both film and chemicals and is likely to specify solutions 
only by name rather than characteristics.
    (Comment 388). One comment recommended that FDA allow accreditation 
bodies to review and monitor the use of chemicals for film processing 
and eliminate the requirement from the regulations.
    Although the agency is continually working with the accreditation 
bodies to divide responsibilities when such division is useful and 
possible, FDA did not adopt the recommendation. The MQSA requirements, 
even when administered by the accreditation bodies, are implemented 
through Federal standards. FDA may consider requiring accreditation 
bodies to collect and monitor information about chemicals used for film 
processing in the future. NMQAAC agreed with the requirement as 
proposed. FDA has codified the requirement in the final regulations 
under Sec. 900.12(b)(13).
    u. Lighting (Sec. 900.12(b)(14) (proposed Sec. 900.12(b)(20)))
    In this paragraph, FDA proposed a requirement that facilities 
provide special lights for use during interpretation with variable 
luminance capable of producing light levels greater than that provided 
by the viewbox.
    (Comment 389). Four comments supported the proposal. One stated 
that ``it might reduce the number of retakes, and provide better detail 
to the interpreting physician.'' Two comments noted that the light 
should be required wherever the interpreting physician is reading 
films, but that it may not be necessary at all locations where images 
are taken. One comment noted that the proposed requirement in 
Sec. 900.12(b)(20) was for a ``bright light'' or ``hot lamp'' for 
viewing dense areas of films. The comment suggested that the purpose of 
the lamp should be included and that it should only be required for 
facilities that use the screen-film modality.
    FDA agrees that the light is only required where mammograms are 
interpreted but recommends that it may be useful to the technologist in 
evaluating the quality of the films. FDA also agrees that facilities 
not interpreting screen-film mammograms, or not reviewing previous 
screen-film mammograms for reference, do not need these special lights.
    (Comment 390). Two comments stated that a fixed output lamp may 
give the same information as the variable output ``hot lamp'' proposed. 
NMQAAC supported the requirement, but recommended that the word 
``variable'' be removed because it is the increased intensity and 
masking provided by the light rather than any variability in output 
that actually enhance the reading of the image.
    FDA has accepted these suggestion and has reworded the final 
requirement accordingly.
    (Comment 391). One comment expressed difficulty imagining the 
benefits of this requirement to the patient.
    FDA believes the usefulness of this device is well established, 
especially in view of the trend toward denser films in mammography; by 
optimizing interpreting conditions for physicians, the regulation 
increases the likelihood that the patient's mammogram will be 
accurately interpreted.
    (Comment 392). One comment recommended that FDA allow accreditation 
bodies to review and govern the proposed requirement in 
Sec. 900.12(b)(20), and eliminate it from the regulations. As indicated 
above in response to a similar comment by the same individual.
    FDA has not adopted the recommendation, although it may consider 
requiring such action by the accreditation bodies in the future.
    (Comment 393). Four comments suggested that the proposed 
requirement was too vague. One comment suggested that the requirement 
be reworded to specify that a ``spot lighting'' device be provided.
    FDA agrees with these comments and amended the final requirement to 
clarify this point.
    (Comment 394). A number of comments chose this section to offer 
suggestions regarding requirements for the viewbox or the viewing 
conditions. FDA has discussed those comments in the general equipment 
section above.
     Because of the deletion or movement of other paragraphs in the 
equipment portion of the proposed regulations, the reworded 
Sec. 900.12(b)(20) was codified as Sec. 900.12(b)(14).
    v. Film masking devices (Sec. 900.12(b)(15) (proposed 
Sec. 900.12(b)(21)))
    In this paragraph, FDA proposed that all facilities ensure the 
presence of film masking devices that are capable of limiting the 
illuminated area of the viewbox to the exposed or smaller area of the 
film, that facilities using nonrectangular collimation ensure suitable 
masking, and that such devices be available to the interpreting 
physicians.
    (Comment 395). Six comments supported the requirement. Two of these 
comments further suggested that the requirement be modified to clarify 
that any effective means of masking, including ``black film or manual 
or automatic masking devices,'' would be acceptable. One comment 
questioned how effective the film masking devices must be because the 
respondent believed that many presently in use do a poor job of 
blocking the unnecessary light. FDA has not attempted to specify 
particular mechanisms for masking, only that provisions for masking be 
available. Any device that blocks viewbox light not required for 
viewing and interpreting the image would meet the intent of this 
requirement. The level of ``blocking'' was not addressed, but with the 
light levels under consideration, the agency believes that the 
elimination of any noticeable transmission through the masking is 
easily achievable. The device need not be an expensive or elaborate 
system, but it must be capable of eliminating extraneous viewbox light.
    (Comment 396). Two comments supported the proposed requirement to 
provide appropriate masking for nonrectangular images as a means to 
further promote the correct masking of all shape images, but another 
comment stated that the nonrectangular collimation referenced should be 
eliminated because ``there is no need for it and it causes significant 
problems in the masking of the films for proper viewing conditions.'' 
NMQAAC suggested that the requirement regarding nonrectangular masking 
was redundant and recommended that it be removed from the final 
regulation.
    FDA does not intend to express a preference for rectangular or 
nonrectangular collimation. This section was included in the proposal 
to reinforce the point that, in all cases, the masking should be 
appropriate to the image. FDA is accepting the NMQAAC recommendation 
and deleting the provision relating to nonrectangular collimation from 
the final regulations; FDA agrees with NMQAAC that the

[[Page 55925]]

general masking specification covers all sizes and shapes of images.
    (Comment 397). One comment questioned how much limitation of the 
exposed image the proposal intended the masking to provide and one 
comment proposed that the masking requirement be expanded to require 
limitation of ``the illuminated area to a region or regions 
substantially smaller than the exposed portion of the film.''
    FDA has not accepted this recommendation because it may not be 
desirable, in all cases, to limit the view to an area ``substantially 
smaller than the exposed portion of the film.'' The intent of the 
section is that masking be as close to the full darkened film area as 
possible. The masking can certainly be variable, so that the darkened 
area can be reduced to a specific area of interest. This is not 
required, however. Discussions with interpreting physicians have led 
FDA to conclude that it is often desirable to visualize the entire 
image to establish a ``gestalt'' impression before further 
interpretation of the film. A masking system that prevented such a 
practice, therefore, may be undesirable and is not being required.
    (Comment 398). One comment questioned to what extent the film 
masking devices were required to be available. The comment asked if all 
mammograms were required to be read on viewboxes equipped with masking 
devices or if the facility need only require adequate masking for one 
viewbox, even if multiple reviewers were reading film at the same time 
on different viewboxes.
    In response to this comment, FDA has modified the final regulation 
to indicate that such devices should be available in sufficient numbers 
to allow each physician requiring one to have access to one. NMQAAC 
recommended that the requirement that the devices be available to 
physicians should be deleted, stating that any physician who desired to 
use masking could provide their own at little or no expense and that 
the facility need not provide such devices for them. FDA partially 
agrees with this assessment but has not accepted this recommendation 
because it has concerns about facilities that require significant 
numbers of films to be read daily and where the interpreting physician 
simply does not have time to individually mask images. Placing 
responsibility with the facility will ensure that masking devices are 
provided in such cases.
    (Comment 399). Two comments recommended that the regulation mandate 
the use of film masking devices by the physician, and one of these 
suggested that masking should be used by the technologists in their 
film critique area. While FDA certainly agrees that both interpreting 
physicians and technologists should utilize masking, the agency 
believes that, if the devices are available, most individuals will use 
them and that requiring their use would be difficult to enforce.
    (Comment 400). One comment stated that film masking devices may be 
expensive to obtain and cumbersome to use. This comment maintained 
that, although film interpretation may be improved by using these 
devices, requiring that facilities provide such devices appears to be 
excessive regulation and this requirement should be deleted.
    FDA notes that the goal of the MQSA is to provide a consistent 
baseline of quality mammography services to all patients. If an item 
that is consistent with that goal is identified as having a positive 
impact on the diagnostic process, FDA believes it is important to 
assure women that facilities at least have these devices available for 
use on their behalf. FDA also notes that masking devices do not 
ordinarily entail significant expense. FDA has codified the requirement 
for availability of masking in the final regulations under 
Sec. 900.12(b)(15).
    w. Film processors (Sec. 900.12(b)(22) (proposed 
Sec. 900.12(b)(22)))
    In this paragraph, FDA proposed a number of requirements for the 
film processors used to develop mammograms. As proposed, 
Sec. 900.12(b)(22)(i), covering processor setup and maintenance, would 
go into effect 1 year after final publication; Sec. 900.12(b)(22)(ii) 
and (iii), requiring display of the time cycle and maintenance of the 
developer temperature, would be phased-in after 5 years; and 
Sec. 900.12(b)(22)(iv) and (v), requiring the display of the developer 
temperature and for variable cycle processors to be interlocked to 
prevent new film being accepted by the processor until cycle parameters 
are stabilized, would be phased-in after 10 years.
    Section 900.12(b)(22)(i) proposed that all such processors be set 
up and maintained at the technical development specifications for the 
film used for mammography at the facility.
    (Comment 401). One comment requested a definition of technical 
development specifications, as used in the proposed regulations. 
Another comment stated that, if it is going to be mandatory to meet 
film manufacturers technical requirements, then manufacturers should be 
required to make written guidelines available as to what factors are 
needed to achieve the maximum result from the film.
    FDA coined the phrase ``technical development specifications'' to 
represent a listing of the technical aspects of correct processing as 
provided by the film manufacturer. This would be expected to include 
such items as correct solutions, proper temperatures, applicable 
immersion times, replenishment rates, and any other instructions the 
manufacturer deemed appropriate and critical to the processing of its 
film. FDA believes that many manufacturers do provide such information 
and that the market advantage these manufacturers will enjoy will 
encourage all manufacturers to do so. The NMQAAC recommended that this 
section be moved to the quality assurance provisions and FDA has 
followed that advice.
    The agency has reconsidered the proposed requirements in 
Sec. 900.12(b)(22)(ii), (iii), (iv), and (v). FDA received a number of 
comments both supporting and opposing these proposals. However, based 
on the anticipated costs associated with these proposals compared with 
the marginal benefits they would provide, FDA has decided to delete 
them from the final regulations. If the agency proposes future 
regulations for these areas, all related comments will be reconsidered.
3. Medical Records and Mammography Reports (Sec. 900.12(c))
    This section establishes quality standards for medical records and 
mammography reports as required by the MQSA under 42 U.S.C. 
263b(f)(1)(G). The regulation provides, in general, that facilities 
prepare written reports of mammography examinations, that results be 
communicated to the patient or provider, and that films be maintained 
for a reasonable period of time or transferred to the patient.
    (Comment 402). Public comments were received on Sec. 900.12(c). The 
most controversial areas were specific provisions in the proposal for 
use of standardized assessment categories in the mammography report, 
written notification of all mammography results, and for original 
mammograms to be transferred to other facilities or entities upon 
patient request. Each of these areas will be discussed below in 
connection with those specific provisions.
    a. General comments
    As an initial matter, FDA disagrees with four comments that asked 
FDA to delete the entire regulation on medical records and reports 
because it was an intrusion of FDA into the practice of medicine and 
abridged the rights of

[[Page 55926]]

radiologists. The agency's authority and responsibility to regulate 
these medical records, mammography reports, and communication of 
results was established by Congress through specific provisions of the 
MQSA. The agency could not eliminate the entire regulation, even if it 
believed such action was appropriate. Discussions with NMQAAC clearly 
indicated the committee's support for regulations in this area as well.
    b. Contents and terminology (Sec. 900.12(c)(1))
    The proposal established standardized assessment categories for 
interpreting physicians to use to evaluate mammograms, ranging from 
``negative'' to ``highly suggestive of malignancy.'' In addition, the 
regulation requires the interpreting physician to address clinical 
questions, if possible, and include recommendations, if any, in the 
report.
    (Comment 403). Comments in support of the proposed standardized 
assessment categories stated that such categories: would ensure that a 
definitive result for each mammogram is reached; would establish 
consistency across facilities; are a valuable tool to assist consumers 
and clinicians in understanding results; should also be used in the 
written notification to patients; and permit efficient and uniform 
analysis of outcomes in medical audits. One comment in support of this 
section suggested that the title be changed to ``Contents, terminology 
and timeframes.''
    Fourteen comments stated that it is inappropriate for the Federal 
government to establish medical terms for classification of mammography 
results through regulation. Other comments opposing the establishment 
of standard assessment categories stated that: Such categories would 
prevent any particular facility from continuing to use its customary 
terminology and, thereby, cause confusion to its referring physicians; 
the message, rather than the exact words, are important and resources 
would be wasted in monitoring the correct use of particular phrases; 
and that establishing standard classifications would reduce flexibility 
for the reporting physicians.
    Some comments objected to the details of a particular 
classification category, rather than to the idea of standard 
classifications. One comment stated that a ``negative'' report may 
mislead a referring physician about the existence of breast cancer 
because mammography cannot detect all breast cancers, while another 
comment concluded that the term ``suspicious'' inherently suggests that 
the lesion is malignant, and proposed ``indeterminate'' as a substitute 
category.
    After considering all these comments, FDA has decided to keep the 
proposed categories in order to promote consistency and clarity in 
mammography interpretations. In discussions with NMQAAC, the use of 
final assessment categories was supported because they promote 
consistency in communication of results among medical care providers 
and standard categories are necessary in the medical audit of 
mammography interpretation. These particular categories are based on 
similar categories developed by ACR. The ACR Breast Imaging Reporting 
and Data System categories are: Assessment Is Incomplete-Need 
Additional Imaging Evaluation; 1-Negative; 2-Benign Finding; 3-Probably 
Benign Finding--Short Interval FollowUp Suggested; 4-Suspicious 
Abnormality--Biopsy Should Be Considered; and 5-Highly Suggestive of 
Malignancy--Appropriate Action Should be Taken.
    FDA believes that the medical community is familiar with these 
categories and the assessment classifications established under the 
final regulations (``negative,'' ``benign,'' ``probably benign,'' 
``suspicious,'' ``highly suggestive of malignancy'') are equivalent to 
the ACR system. The medical community has already affirmed their 
usefulness and value through widespread use of the ACR system. 
Accordingly, the agency concludes that requiring these classification 
terms in mammography reports will not be burdensome, given their 
current level of use and acceptance.
    FDA has made minor changes in particular assessment categories in 
response to comments. Two comments requested FDA to delete the word 
``imaging'' from the proposed assessment category of ``needs additional 
imaging evaluation'' and substitute the ACR category of ``needs 
additional evaluation'' because physical examination may be part of 
further evaluation. In fact, the ACR category is ``Need Additional 
Imaging Evaluation,'' with ``incomplete'' as its descriptor. 
Accordingly, FDA is adding the word ``incomplete'' to the description 
of this category, which will now read: ``Incomplete: needs additional 
imaging evaluation.'' The mammographic result should be categorized 
into this or one of the other assessment categories. The agency notes 
that, if the result is ``negative'' or ``probably benign'' based on the 
mammogram, but physical examination is recommended, the recommendation 
for clinical followup, surgical consultation, biopsy, or other action 
should be stated in the recommendations section of the report. The 
agency also is aware that there are screening mammography practices 
that do not issue a final assessment until followup diagnostic 
mammography has been scheduled and performed. These facilities, and 
others, can continue their policy of not issuing an assessment, and can 
use this category of ``Incomplete: needs additional imaging 
evaluation.''
    FDA's proposed language for the ``negative'' category stated that 
if the interpreting physician is aware of clinical findings or 
symptoms, these should be explained. One comment asked if this 
explanation must be written into the report or could be attached as a 
symptom in-take form. The agency believes that the recommendations 
section of the report is the most effective way to direct referring 
health care providers to further work-up based on physical findings or 
symptoms, despite negative mammographic results.
    (Comment 404). One comment stated that it would be hard to 
determine compliance with the proposed requirement that clinical 
questions raised by the referring health care provider be addressed in 
the recommendation section of the report.
    FDA responds that it can determine compliance with a regulation in 
a variety of ways, including review during an inspection of a 
facility's standard operating procedures. FDA inspectors can be trained 
to verify that each facility has in place a system that requires its 
interpreting physicians to address the concerns of referring health 
care providers in the recommendations section of the mammography 
report. FDA agrees with comments that suggested that the recommendation 
section of the report remain separate and unstructured; the agency has 
not proposed specific categories or language for this portion of the 
report in order to provide maximum flexibility for clinical management 
recommendations.
    (Comment 405). One comment stated that there should be a unique 
patient identifier to distinguish between two patients with the same 
first and last name. NMQAAC also agreed, stating that the medical 
report and the mammography films should have a patient identifier in 
addition to the name. FDA agrees that an additional patient identifier 
in addition to the name will improve the accuracy and clarity of the 
results and subsequent followup and the proposal has been amended to 
require reports to have this additional identifier. However, the

[[Page 55927]]

choice of the additional identifier, such as the date of birth or 
hospital number, is left up to the facility because each individual 
practice has a better understanding of its particular needs in this 
matter.
    (Comment 406). Two comments asked if a radiologist who did not read 
the film or dictate the report can sign a report if the radiologist who 
did perform the interpretation is unavailable and concurs with this 
practice. Another comment stated that FDA should allow signatures that 
are authenticated through computers, which are normally accepted in a 
court of law. A third comment stated that signatures should be evident 
on the report filed in the patient's permanent file.
    FDA interprets the MQSA's requirement that each mammography report 
be ``signed'' by the interpreting physician to mean that each report 
must identify who interpreted the mammogram and rendered the reading on 
the written report. The final regulations state that the name of the 
interpreting physician must be on the mammography medical report. This 
name may be handwritten, typed, stamped, written electronically, or 
recorded in any other manner. However, with respect to ``signatures'' 
that are used to proof-read reports or to ``sign'' them out for 
purposes of authenticating such reports or releasing them to other 
parties or institutions, FDA believes that each facility is in the best 
position to devise its own procedures to ensure accuracy of reports and 
integrity of the system without the MQSA regulations in this area.
    (Comment 407). One comment recommended that there be a requirement 
for facilities to maintain records that include the signature of the 
qualified radiologic technologist who performed or supervised the 
examination and the signature of any individual who conducted all or 
part of the examination under supervision of a qualified radiologic 
technologist.
    FDA disagrees with this comment. The MQSA does not have a signature 
requirement for the technologist. The final regulations require 
``technologist identification'' on each film image 
(Sec. 900.4(c)(viii)(E)) and the agency believes each facility can 
adopt its own system to identify technologists without having the 
agency mandate such procedures.
    (Comment 408). One comment suggested that the term ``health care 
provider'' should be replaced with ``referring physician.'' FDA 
disagrees because patients are referred for mammograms by 
nonphysicians, such as physician's assistants, nurse practitioners, and 
other health care workers.
    c. Communication of mammography results to patients 
(Sec. 900.12(c)(2))
    This provision requires that: (1) Each facility establish a system 
to ensure that results are communicated to patients; (2) patients 
without health care providers receive medical reports and lay summaries 
of their mammography results; (3) each facility establish a referral 
system for patients without health care providers, if necessary; and 
(4) results that are ``suspicious'' or ``highly suggestive of 
malignancy'' be communicated as soon as possible.
    (Comment 409). FDA received hundreds of comments on the proposal 
that all patients receive written results of their mammography 
examination. Comments that objected to this proposal generally focused 
on disruption of doctor-patient relationships, confusion for patients, 
and additional expense to facilities without commensurate patient 
benefit. Ninety comments stated that the referring health care provider 
is responsible for communicating results to patients and is best able 
to convey such results and answer patient questions. Other comments 
that raised concerns about disrupting the referring doctor-patient 
relationship stated that written notification from the facility would 
allow patients to bypass a referring physician and never get a physical 
breast examination. Many comments stated that written notification to 
every patient would cause confusion for the patients. Twenty-three 
comments said confusion would arise if patients were notified about 
results before such results were reviewed by their referring 
physicians; twenty-one comments stated that many patients would 
misinterpret their reports; ten comments stated that the difference 
between the information provided in a lay notification and the 
information contained in a copy of the actual written report would 
confuse patients who received both.
    Seventy-two comments stated that the additional cost associated 
with written communication to every patient would cause financial 
hardship for mammography facilities. In general, these comments and 
others argued that the cost of providing or ensuring written 
notification in every case outweighs any patient benefit that might 
result. Ten comments stated that radiologists would have to police 
referring physicians who agreed to provide patient notifications and 
followup. Other comments stated that: (1) Small or rural facilities 
would be burdened by patient notification requirements, especially 
those without a computerized system; (2) producing patient notification 
reports is time-consuming and hinders the accomplishment of daily 
operations, and would not directly improve patient care; (3) developing 
a notification document that could explain every possible scenario 
involving diagnostic findings is virtually impossible; and (4) 
radiologists and providers of mammography would become more frequent 
targets of litigation because of this reporting requirement. Thirty-
seven comments stated that it is unrealistic to expect radiologists, 
who may never see patients, to determine the literacy level, ethnic, 
cultural, and social sensibilities of those patients in order to tailor 
an appropriate written notification. Fifteen comments stated that the 
requirement would create excessive waste paper for the environment. 
Some comments found the proposal for written notification unnecessary 
in light of other reporting and followup requirements, the individual 
patient's responsibility to communicate with her physician, and the 
belief that patients are always informed of results by their 
physicians. Two comments asserted that written notification for all 
patients was not authorized by the MQSA.
    FDA also received 66 comments that supported the proposal for all 
patients to receive written notification of mammography results 
including comments offering strong support from national breast cancer 
patient groups. These comments generally focused on the fact that women 
otherwise were not assured of timely and accurate information about 
their mammography examinations and that such written notification could 
save lives by encouraging initiation of necessary followup.
    It was also noted that the experience of facilities that instituted 
such notification was positive. Comments in support of written patient 
notification stated that such notification was appropriate because 
patients are entitled to know the results of their exams, it is the 
facility's responsibility to inform patients of results, and there is a 
public health need for written notification because not all referring 
physicians discuss results with their patients.
    (Comment 410). Comments described written notification as an 
important addition to quality mammography practice, a crucial component 
to ensuring reliable mammography and consistency across the country, 
and a major step toward fostering better communication between doctors 
and their patients. One comment supported the proposed system to ensure 
that patients and referring physicians receive reports, and that all 
patients receive a

[[Page 55928]]

report in lay terms, but also stated that the referring physician 
should continue to be responsible for patient followup. Another comment 
stated that FDA should not allow any party, other than the facility, to 
distribute these written notifications.
    Many comments asserted that written notification for each patient 
may ultimately reduce health care costs and extend lives because of 
earlier treatment. Five comments stated that written notification 
empowers the medical consumer and minimizes the possibility of tragic 
error when abnormal results slip through the cracks of the referring 
physician systems. Comments asserted that referring physicians do not 
always communicate results to patients, even when the results are 
abnormal. Several breast cancer survivors commented positively on this 
proposed requirement and one author stated that such written 
notification saved her life. Seven comments stated written notification 
has reduced medical liability of facilities, but that costs should be 
offset with increased reimbursement.
    Comments from State health officials and some facilities having 
experience with written patient notification reported that the 
experience had been positive. Facilities that have instituted written 
notification stated that the practice is appreciated by patients and 
does not cause the facility any particular hardship. Massachusetts has 
required such written notification since 1994. The comment from a State 
official stated that, although initially resisted, the procedure is now 
accepted by physicians throughout the State; facilities in 
Massachusetts receive positive feedback from patients and no facility 
has closed in that State because of this additional requirement.
    Some comments recommended that the notification include additional 
information. Twelve comments asked that the written notification also 
include information about the location of the films, directions about 
how a woman could obtain them, and the facility contact person for 
questions concerning the result. Another comment said the notification 
should include information about the importance of clinical breast 
examinations by a qualified physician, monthly self-breast 
examinations, and mammograms at appropriate times, especially for 
patients without physicians. Some comments wanted facilities to be 
required to provide written notification to referring physicians and 
patients.
    Many comments suggested alternatives that were variations to the 
proposed requirement for written patient notification. Ten comments 
supported the current interim regulations, which require written 
notification from the facility only to those patients who do not have a 
health care provider or referring physician. Thirteen comments stated 
that, for referred patients, the required notification should simply 
state that the mammogram report has been mailed to the physician and 
the examinee should contact that physician. Twelve comments stated that 
only those patients who request a written report should be sent one.
    Other comments agreed that patient notification of results by the 
facility was appropriate, but preferred to leave the method of 
communication up to the facility, which could tailor notification 
procedures to its practices and the circumstances of particular 
patients. Comments observed that in some screening cases, where the 
radiologist never speaks to the patient, written notification of 
results makes sense; however, where there is extensive interaction and 
verbal communication with the examinee onsite, written notification can 
be redundant, expensive, and wasteful of paper. Five comments stated 
that patients should be verbally told at the time of the examination to 
contact her physician's office and not to assume that ``no news is good 
news.'' Other alternatives suggested by comments included several that 
were in direct contradiction to each other: (1) Require written 
notification only to those patients who have not received the final 
report verbally at the facility or, if findings are negative, by 
telephone; (2) encourage notification of patients with abnormal 
studies; (3) require patient notification in lay terms only if the 
results are negative and notify referring physicians, including 
followup notes, when there are abnormal results; (4) send referring 
physicians lists of patients who had mammography at a facility with 
positive studies highlighted; (5) require notification of patients who 
request results after a specified time period has passed in order to 
allow communication between the patient and the referring physician and 
to prevent duplication and failure to inform; and (6) require that 
every patient receive a copy of her mammography report, if desired, or 
by default if her preference is not stated.
    After reviewing and considering the hundreds of comments FDA 
received concerning patient notification, the agency concluded that 
these many comments all share the common goal of providing an effective 
mechanism for communicating mammography results to patients, but that 
the comments clearly advocate different approaches to achieving this 
goal. FDA agrees with consumer groups that written notification of 
mammographic results represents ``best practices'' in ensuring that 
each and every woman is clearly and effectively notified of the results 
of her mammogram. These ``best practices'' are outlined clearly in a 
series of recommendations published by AHCPR in Chapter 4 of the 1994 
guidelines entitled, ``Quality Determinants of Mammography'' (Ref. 2). 
In these guidelines AHCPR strongly recommends that mammography facility 
personnel provide each patient with written notification of the results 
of her mammography examination either onsite or by mail. Studies cited 
by AHCPR have shown that direct communication with patients, which is 
in addition to written communication to health care providers, 
dramatically increases compliance with followup recommendations. 
However, FDA also recognizes that many in the health care community 
have strong reservations, for the many reasons cited above, about 
making written notification to all patients a Federal requirement. 
Finally, FDA notes that although the MQSA requires mammography 
facilities to notify patients' referring physicians, in writing, of the 
examination results, the statute requires those facilities to notify 
patients directly in writing, only in those instances where the patient 
has no referring physician. FDA believes that the best way to reconcile 
the many different points of view on this subject--and achieve the goal 
of effective patient notification consistent with the statute--is to 
issue a general rule requiring patient notification, together with a 
recommendation that facilities follow the AHCPR guidelines regarding 
written notifications to patients. The relevant portions of the AHCPR 
guidelines have been printed as an appendix to the preamble of this 
document for ease of reference.
    Accordingly, the agency has revised the final rule to eliminate the 
requirement for written notification to every patient and has 
substituted a performance-based regulation that requires each facility 
to ensure that the results of each mammographic examination are 
communicated to the patient. Under the final rule, each facility will 
be responsible for establishing a system of notification, through its 
own efforts or in cooperation with third parties, that guarantees that 
patients are informed of the results of their examinations in a timely 
manner. The system must also ensure that women who do not have health 
care

[[Page 55929]]

providers receive written notification, along with the mammography 
medical report, no later than 30 days following an examination and that 
each facility communicate abnormal results as soon as possible.
    As noted above, FDA continues to believe that written notification 
of mammographic results is the most reliable way to guarantee that each 
patient is notified of results and that any necessary followup will 
occur. Comments from consumer groups and breast cancer survivors about 
the importance of early and accurate communication to patients supports 
the public health need for systems that ensure patient notification. 
Written notification to a patient of results can permit that patient to 
make informed medical decisions at critical times. One cancer survivor 
informed the agency that having the actual results of an abnormal study 
in hand allowed her to pursue treatment options that saved her life. 
Furthermore, the agency disagrees with comments that assume all 
patients are notified of their mammographic results; many referring 
health care providers do not communicate results of mammograms to 
patients and the adage ``no news is good news'' still rings true for 
many patients. During the MQSA inspections, FDA has uncovered a handful 
of facilities that do not even issue written mammography reports to 
referring physicians. Accordingly, the agency is continuing to require 
each facility to establish systems that will ensure that patients are 
notified of the results of their mammograms.
    FDA believes that high quality mammography extends from the 
production of high quality mammographic images to the communication of 
results to the patient. Ensuring that patients get their results is the 
responsibility of all participants in the mammography imaging chain: 
The patient, the facility, and the referring health care provider. The 
final regulations fully charge facilities to meet their responsibility.
    At its January 1997 meeting, NMQAAC recommended that all facilities 
should not be required to provide written notification. While some 
concern was voiced about difficulties in directly notifying all 
patients who underwent diagnostic mammography, many members advised FDA 
to require some type of direct notification of all patients and that 
this notification be documented. Although the agency continues to 
support written notification to all patients as the optimum practice 
under most circumstances, the final regulation does not prescribe any 
particular form of notification. Comments from facilities and 
physicians indicate that facilities have devised a variety of systems 
of communication to notify patients of mammography results. These 
include verbal conversations at the time of the examination, telephone 
communication after the examination, cooperative arrangements with 
referring physicians who convey the results verbally to their own 
patients, and written communications that are either directly issued 
from the facility and convey results or instruct the referring 
physicians to issue these reports. The AHCPR guidelines recommending 
direct written communication to all patients also provided examples and 
suggestions about the other types of communication.
    Under the final regulation, in the case where a facility decides to 
rely on a third party to communicate results (either written or 
verbally), there should be a documented agreement between the facility 
and the third party that establishes this cooperative responsibility. 
This documentation may be in the form of attestation by the third party 
or letters of agreement signed by the third party. In addition, the 
agency reserves the right during inspections to confirm not only the 
presence of such documentation, but also to ask for further 
documentation from the facility to verify that patients were indeed 
notified. Further documentation can include copies of referring 
physician medical records documenting that results were discussed or 
sent to the patient. These descriptions of systems and documentation 
are intended to be examples; others may also be acceptable. However, if 
third parties do not provide the mammography facility with further 
documentation when requested during inspections, the mammography 
facility is subject to regulatory enforcement action under the MQSA for 
failing to document that results were provided to patients. Thus, for 
facilities that choose to rely on third parties for communicating 
results, whether they be referring physicians or communication 
consultants or other parties, the facility still has ultimate 
responsibility to meet the patient notification requirements of the 
final regulations.
    The agency also believes that the approach taken in the final 
regulation will address the concerns about communication and cost that 
were raised by so many of the comments. The flexibility that has been 
built into the final regulation will permit facilities to tailor 
notification systems to the particular needs of the general patient 
population and individual patients they serve. At the same time, 
requiring each facility to establish and document the existence and 
operation of such systems achieves the primary goal of ensuring that 
patients receive the results of their mammograms.
    In addition, the agency notes that the requirement for reasonable 
attempts at immediate communication when results of an examination are 
``suspicious'' or ``highly suggestive of malignancy'' has been retained 
in the final regulation. Potential delays in diagnosing and treating 
breast cancer are reduced with this requirement that facilities 
directly notify patients who have no health care provider of abnormal 
results as soon as possible. (The same requirement for immediate 
communication in the case of ``suspicious'' or ``highly suggestive of 
malignancy'' findings applies to the facility's communication with the 
referring physicians of those women who have identified health care 
providers). The agency concludes, therefore, that the most significant 
public health risk that may result from failure to communicate results 
is addressed in the final regulation.
    The final regulation continues to require written notification by 
facilities to patients who do not have referring physicians, as 
specified in the MQSA. The statute also sets forth, and the regulation 
incorporates, the requirement that such self-referred patients receive 
a copy of the actual mammography report that would be prepared and sent 
to the referring physician, if there were one. In response to comments 
that questioned the agency's authority to require patient notification, 
FDA notes that the language of the MQSA is very explicit with respect 
to patient notification of test results and the form that notification 
must take in these particular circumstances (see 42 U.S.C. 
263b(f)(1)(G)).
    (Comment 411). Many comments urged FDA to require referring 
physicians to be responsible for the communication and followup of 
results of mammography examinations. FDA agrees that a physician with 
knowledge of a particular patient's entire medical history is often the 
best source of communication and followup of results. However, FDA's 
primary jurisdiction under the MQSA is related to mammography 
facilities and not individual practices of referring health care 
providers.
    One comment suggested an arrangement whereby facilities and each 
provider of care enter into a written agreement that the referring 
physician assumes responsibility and liability for informing his or her 
patients of mammography results, and the mammography facility would be

[[Page 55930]]

allowed to breach this contract at any time when a patient requests the 
results in writing. FDA agrees that this arrangement would meet the 
requirements of the final regulations. However, if referring physicians 
fail to communicate results to patients despite their agreement to do 
so, the mammography facility is responsible under the MQSA for failing 
to ensure communication of results and is subject to regulatory action 
by FDA.
    FDA intends to look for documentation during inspections to 
establish that patient notification systems are in place and 
operational. For example, if a verbal communication system is used to 
tell patients of results, this communication should be documented in 
the patient's medical record and should be capable of verification by 
the MQSA inspectors. If a facility sends letters to patients, records 
of that correspondence, or standard operating procedures describing 
this correspondence, must be available for inspection. In circumstances 
where a facility relies on referring physicians or other third parties 
to communicate results to patients, the facility must provide 
documentation of these arrangement and their implementation, as 
described above. In those cases where the mammography facility is the 
primary breast care provider for the patient, there must be 
documentation of results being conveyed to the patients. By allowing a 
variety of notification systems, the agency has attempted to ensure 
that communication of results will be accomplished effectively, but 
without undue burden on mammography practices or unnecessary increases 
in the cost of mammography services. Finally, the agency notes that the 
regulations being issued to require facilities to establish and 
maintain systems that ensure patient notification of results does not 
preclude any patient from requesting additional reports or records from 
the facility. Nothing in the record and report section of the MQSA 
should be construed to limit a patient's access to the patient's 
medical records (42 U.S.C. 263b(f)(1)).
    (Comment 412). One comment stated that FDA's intention to inspect 
and monitor systems established by facilities to verify that patients 
receive notification of results in lay language is unrealistic and that 
facilities should not be required to establish such systems.
    FDA disagrees. FDA has issued interim regulations, as required by 
the MQSA, that required notices in lay language to be issued, along 
with the actual report when patients do not have a referring health 
care provider (42 U.S.C. 263b(f)(1)(G)(ii)(IV)). This is a current 
requirement for all facilities and is already subject to inspection and 
verification.
    (Comment 413). One comment stated that complex situations, such as 
when a mammogram is assessed as negative, but the patient has clinical 
findings, need careful explanation to patients so that the importance 
of the situation and recommendation for followup will be understood. 
This comment recommended that the mammography facility be responsible 
for patient care if it is accepting women who have no physicians.
    FDA believes this practice standard is largely being adopted by the 
mammography community and supports this. Under the final regulations, 
each facility is required to maintain a system for referring patients 
to health care providers when clinical followup is recommended and the 
patient has no physician.
    (Comment 414). One comment stated that followup reminder letters 
are critical and should be mandated.
    FDA disagrees that these should be mandated. Rather, each practice 
should be allowed to determine if such letters or other forms of 
reminders are needed.
    (Comment 415). One comment reflected confusion about the immediate 
followup call to patients required under Sec. 900.12(c)(2), which is in 
addition to the notification requirements. Although notification is 
required for all patients under the system established by the facility 
to ensure such communication, FDA believes that special efforts at 
communication are required when there are abnormal results and the 
patient does not have a referring physician. In these cases, the 
facility is expected to contact the patient who has no health care 
provider as soon as possible and the 30-day timeframe for sending 
reports and long summaries is superseded. Under the final regulations, 
this immediate communication is required only in situations where the 
probability of cancer is high (mammograms assessed as ``suspicious'' or 
``highly suggestive of malignancy''). In cases where such immediate 
notification is required, the facility remains obligated to also 
provide the necessary written notifications within 30 days as followup.
    (Comment 416). One comment supported the requirement that, when an 
examination shows suspicious findings, a facility should directly 
communicate with a nonreferred patient. This provides patents the 
assurance that they will receive the care they need.
    FDA agrees and the final regulations contain this requirement.
    (Comment 417). One comment stated that, in cases where assessments 
are ``suspicious'' or ``highly suggestive of malignancy'' and results 
must be ``immediately'' communicated to the examinee or physician, FDA 
should define what ``immediately'' means. Another comment suggested 
``immediately'' be defined as 24 hours.
    FDA believes that the variety of circumstances that may arise when 
followup is required make a rigid definition of ``immediate'' 
unreasonable. Because there are circumstances when immediate 
communication is not possible, FDA has revised the requirement to 
communicate abnormal results from ``immediately'' to ``as soon as 
possible.'' Health care professionals understand the importance of 
accomplishing such notification when there are suspicious or highly 
suggestive findings. Although it is impossible to establish a precise 
timeframe, FDA expects such communication ordinarily can be 
accomplished within 48 to 72 hours and not later than a week following 
the examination.
    (Comment 418). One comment stated that 30 days is an unreasonably 
long window in which to notify patients of results. Three other 
comments agreed with FDA that 30 days was reasonable. Another comment 
stated that reports and notification should not be sent out for at 
least 5 days in order to wait for outside comparison films; otherwise, 
addenda lay notification and reports would confuse patients and 
physicians. Another comment recommended that notification to patients 
should wait until all mammography imaging work up has been completed.
    FDA believes that issuing medical reports to health care providers 
(or to patients with no health care providers along with lay summaries) 
within 30 days is a reasonable standard. This does not mean facilities 
must wait 30 days, as the first comment suggests, but rather that 30 
days is the outside limit. FDA disagrees that notification of results 
should be delayed until the total imaging work-up is completed because 
situations arise when imaging work-ups can extend over more than 1 
month. Therefore, FDA is requiring a report of the medical finding for 
each mammogram to be generated within 30 days. Under the final 
regulations, facilities must also ensure that patients have their 
results communicated to them within that time. Many facilities may 
notify patients or have other parties notify patients after written 
medical reports are provided to physicians; other facilities may choose 
to communicate

[[Page 55931]]

results to patients prior to the issuance of the medical report to the 
referring provider by means such as providing verbal results at the 
time of the mammography examination. As discussed above, a variety of 
systems will be acceptable as long as they ensure that results are 
communicated to patients and that communication is timely.
    (Comment 419). Eight comments stated that patients without health 
care providers should not get the actual medical report along with the 
lay notification. These comments claimed that the terminology in the 
medical reports would confuse patients and either generate more 
inquiries or keep them from understanding that further studies are 
needed. They recommended instead, that patients can request the report 
be sent to a physician if further medical advice is desired. One 
comment also stated that, while it is critical to include the patient 
in the information loop for the results of her mammogram, it is poor 
medicine to send the patient who is self-referred the copy of the 
mammogram report that is intended for the physician.
    FDA disagrees. The MQSA expressly requires facilities to provide 
patients without referring physicians both the medical report and the 
lay summary (42 U.S.C. 263b(f)(1)(G)(ii)). This requirement allows the 
patient to provide her mammography report immediately to a subsequent 
health care provider, if needed.
    (Comment 420). Two comments asked what is meant by ``reasonable 
attempts'' to communicate results of suspicious studies to patients 
without referring physicians as soon as possible. The comments asked 
whether a certain number of phone calls or a registered letter would be 
acceptable.
    FDA does not intend to mandate procedures for communication with 
patients in these circumstances because different methods are likely to 
be more or less effective with different facilities and patient 
populations. Telephone calls and registered mail are examples of 
attempts at communication that may work. Verification that contact has 
been made is the goal. Each facility can consult with its risk 
management director to establish procedures to convey results and 
document attempts at communication that are ``reasonable.'' FDA 
recommends that mammography facilities utilize the AHCPR's guidelines 
in ``Quality Determinants of Mammography'' that address the effective 
communication of mammography results to patients and follow those 
guidelines with respect to written notification to patients. That 
document includes excellent sample lay notices that facilities could 
adopt. As noted previously, information from Chapter 4 of these 
guidelines has been reprinted as an appendix to the preamble of this 
document for ease of reference.
    d. Communication of mammography results to health care providers 
(Sec. 900.12(c)(3))
    The final regulation requires each facility to provide the 
mammography report to a referring or named health provider within 30 
days of the date of the examination. The regulation also requires a 
facility to make reasonable attempts to communicate with the health 
care provider or the provider's designee as soon as possible when an 
examination reveals suspicious results. These requirements paralleled 
those for communication of suspicious results to patients without 
identified health care providers.
    (Comment 421). Five comments requested guidance in defining who is 
a responsible designee of the health care provider.
    In response, the agency notes that when referring health care 
providers are not available, they ordinarily have responsible 
designees, such as medical coverage services or partners, to assume 
medical responsibilities for the unavailable provider's patients. These 
requirements parallel and complement those related to patient 
notification.
    (Comment 422). Twenty-nine comments stated that 30 days is a 
reasonable time period for getting reports out (unless there are delays 
in obtaining comparison studies). Three comments asked FDA to define 
the timeframe required for ``immediately'' communicating the results of 
suspicious or highly suggestive mammograms to health care providers. 
One comment expressed concern that the requirement to attempt to 
communicate ``suspicious'' or ``highly suspicious of malignancy'' 
findings to health care providers immediately will impose an 
unmanageable burden on understaffed facilities.
    FDA disagrees with this last comment but, as with the provision 
relating to communication with patients, the agency has changed the 
language from ``immediate'' to ``as soon as possible'' because 
immediate communication may not be possible given the variety of 
circumstances that may be associated with communication of suspicious 
results to a particular provider. FDA believes health professionals 
understand the urgency of the situation when a patient has a suspicious 
or highly suggestive mammogram and they are mandated to communicate 
this result to the referring health care provider in an attempt to 
expedite diagnosis or treatment. Again, although it is not realistic to 
mandate a rigid schedule, the agency expects that such communication 
ordinarily can occur within 48-72 hours, and not later than a week 
following the evaluation of the examination. NMQAAC discussed this 
section and supported the regulations as revised.
    (Comment 423). One comment questioned the ability of physicians who 
read only twice a week to comply with the requirement to communicate 
with health care providers within the mandated timeframes. FDA believes 
timeframes and procedures are sufficiently flexible to balance the need 
to protect patient health with the realities of good mammography 
practices. Reading twice a week does not preclude a physician or the 
facility that employs that physician from complying with the 
requirements.
    (Comment 424). Another comment recommended that radiological 
reports transmitted to the referring physician be acknowledged by 
electronic signature, which should be kept in the electronic file 
indefinitely. As stated previously, with respect to proof-reading 
reports and ``signing'' them out (for authentification or release), FDA 
assumes that facilities are able to devise their own procedures to 
ensure accuracy of reports and integrity of the system without the MQSA 
regulations at this time.
    e. Recordkeeping (Sec. 900.12(c)(4)) 
    FDA's final regulation implementing recordkeeping standards for 
facilities requires each facility to maintain films and reports at 
least 5 years or until the patient requests them or requests their 
transfer. If the film and report represent the only mammogram for that 
patient, the facility must retain them for 10 years or for any longer 
period of time that is required by State law or until the patient 
requests them or requests their transfer.
    FDA received numerous comments supporting its proposal to require 
transfer of the original mammogram upon the request of the patient.
    (Comment 425). Fourteen comments stated that original films should 
be transferred because copies are frequently poor quality and 
jeopardize successful followup. Four comments stated that the request 
for transfer should be in writing and that the regulation should state 
``temporary or permanent transfer.''
    FDA believes each facility should be free to establish its own 
procedures for transfer of films and may wish to consult its risk 
management director for

[[Page 55932]]

guidance. FDA agrees in part with the last comment and has modified the 
final regulation to clarify that a patient may request that the 
transfer of the original films be temporary or permanent. FDA will 
leave it to the facility to decide whether the request for transfer 
should be in writing or may take some other form. NMQAAC also supported 
the addition of this language to the final regulation.
    The agency has also amended the language of the provision to 
clarify that a request for a transfer supersedes a facility's 
responsibility to maintain the films for a particular length of time 
and that the request may be made by an individual on behalf of the 
patient as, for example, might be necessary in cases where the patient 
is incapacitated or has a legal guardian.
    (Comment 426). Two comments agreed that original mammograms should 
be sent for comparison to other facilities. However, these comments 
stated that FDA's suggestion in the preamble to the proposal that 
facilities make a copy is very difficult and expensive. Another comment 
stated that copying originals to retain in the record when transfer is 
requested should not be required because this would increase costs, 
would not be adequate for comparisons, and would delay sending films 
out in the timely manner.
    In response to these comments, the agency notes that there are no 
requirements for facilities to make copies of films they are requested 
to transfer. If this suggestion to make and keep a copy of the 
mammograms is not practical or useful to a facility, it need not be 
followed.
    (Comment 427). Three comments supported the transfer of original 
films, but would require their return within 30 days in cases of 
temporary transfer.
    FDA does not intend to establish a time limit on transfer of films 
at the request of patients. Even in cases where the transfer is 
temporary, the originals may be used during clinical procedures that 
may not be completed in 30 days. However, FDA does support the return 
of films in a timely manner and expects facilities that transfer and 
receive films under such circumstances to cooperate in the interest of 
the patient's treatment.
    (Comment 428). FDA also received many comments expressing concerns 
about original film transfers. Twenty-six comments stated that 
transferring original films is problematic because the films may be 
lost, their transfer may breach confidentiality, the originating 
institution will not be able to make comparisons, and patient may be 
denied access to films at a later date. One comment stated that FDA 
should clarify if the transfer of original films conflicts with State 
or locals laws and how facilities should proceed if that is the case. 
Four comments urged FDA to delete the proposal because the films 
themselves are historically the property of the physician or 
institution which generated them and their absence would disadvantage 
those physicians or institutions in defending against claims asserted 
against them. Fourteen comments asked if FDA will indemnify the 
radiologist for not having original films in the event of a malpractice 
action. One comment stated that there is no enforcement provision 
against those facilities who refuse to release original mammography 
studies on the grounds of ownership or the potential for legal action.
    FDA understands that the transfer of original films has not been a 
universal practice among facilities and that physicians may have 
concerns about the consequences of loss or misplacement. Nevertheless, 
the agency has concluded that the overwhelming benefit to patients from 
access to original films by other facilities or physicians providing 
followup for patients justifies the need for this provision in the 
final rule.
    All expert comments FDA received on this matter, including advice 
from NMQAAC, emphasized the value of having original films for 
comparison to subsequent studies or followup clinical procedures. There 
was general agreement that copies of mammograms could not adequately 
substitute for originals when difficult diagnoses or additional 
procedures were required, and that clinical decisions, such as whether 
to do surgery, require review of original films. The agency notes that 
even those practitioners who criticized the proposal agreed that the 
transfer of films was likely to enhance patient care. Those who 
objected did so on grounds that were unrelated to patient care, namely 
potential for liability and difficulty in defending malpractice 
actions.
    FDA has not been persuaded that these concerns are insurmountable 
or that they are sufficient to override the public health benefits 
associated with the provision.
    Many facilities do routinely transfer films upon the request of 
patients and have established procedures and systems to implement that 
process. Those procedures may include written requests from patients, 
release forms that establish transfer of responsibility for the films, 
and agreements with receiving institutions for subsequent return. In 
some cases, facilities that transfer films do make and retain copies 
for their own files; other facilities have determined that the expense 
of copying is not warranted. Loss of films will not be indemnified by 
FDA.
    With respect to facility concerns about defense of malpractice 
claims, FDA notes that rules of evidence, including civil discovery, 
establish judicial procedures that are designed to protect each party's 
ability to develop its case. Judges have authority and discretion to 
craft remedies in situations where a patient has lost, withheld, or is 
resisting production or examination of a necessary original record.
    FDA is not aware of any State laws that conflict with the 
requirement that original films be transferred upon the patient's 
request. State laws governing the management and retention of medical 
records appear to be silent about the transfer of original films. 
Rather, they are likely to state that patients are entitled to copies 
of their records or that doctors are required to maintain records. This 
was the case with the Florida and New York laws that were brought to 
the attention of the agency.
    Were a State to enact a law that conflicts with this regulation or 
if, contrary to FDA's understanding, such laws currently do exist, 
those State laws would be preempted. The agency disagrees with comments 
that have inferred such laws would be permissible under the provision 
of the MQSA that allows States to establish more stringent requirements 
relating to mammography (42 U.S.C. 263b(m)). The public policy 
considerations underlying any State laws that would restrict a 
patient's access to original films and the quality data that may only 
be available from these original studies would not be related to the 
public health objectives of the MQSA. Accordingly, such State laws 
could not be characterized as more stringent than the MQSA or this 
regulation. The agency also notes that the records provision of the 
MQSA that is being implemented by this regulation explicitly states 
that nothing in that provision shall be construed to limit a patient's 
access to that patient's medical records (42 U.S.C. 263b(f)(1)(G)).
    (Comment 429). One comment recommended that FDA add that, upon 
receipt of authorization to release mammography film, the mammography 
facility must forward the films to the requestor in a reasonable 
timeframe to minimize reporting delays. Another comment suggested that 
each facility be required to provide original films and copies of 
reports within 10 working days of receipt of a written request.
    FDA does not believe it is necessary or useful to mandate the 
details of such transfers. The agency believes that each

[[Page 55933]]

facility will develop standard operating procedures to implement this 
standard and that those procedures will reflect the controls required 
by risk management and acceptable practice standards.
    (Comment 430). Six comments suggested that the facility that took 
the most recent mammogram should maintain ownership of all the 
originals because this practice would make it easier to keep the films 
available for future comparisons. FDA's final regulations do not 
preclude this arrangement if the patient requests transfer of previous 
films to the current facility.
    (Comment 431). Twenty-four comments asked who should bear the cost 
of copying films when the original is released. One comment stated that 
facilities should only be able to charge a nominal fee for transfer of 
films and reports. Another comment believed that the fees must be 
closely monitored; the comment noted that reports have been received in 
the past from facilities charging unreasonably high fees for sending 
reports and copies of mammography films. A third comment stated that 
FDA should develop fee guidelines for charges for copying film and 
postage to prevent some institutions from charging high fees.
    FDA generally agrees with these comments and its final regulations 
limit charges to the documented cost of the transfer, so as to not 
deter patients from requesting transfers when necessary. The agency 
notes that nothing in the regulations requires facilities to charge 
fees for transfer of records. If copies are made as part of the 
facility's standard transfer process, then the cost of copies may be 
documented and included in the transfer fee charged by the facility.
    (Comment 432). One comment asked if the fee can include a storage 
charge or is it for medical records transfer only.
    The regulations clearly state that any fee is for services provided 
under Sec. 900.12(c)(4)(ii), which is the transfer of films and 
reports.
    (Comment 433). Twelve comments stated that the proposal that fees 
charged for transfer of films and records not exceed costs appears to 
be price controls, if not price fixing.
    The agency does not agree that it has taken any action to establish 
prices. FDA is responding to complaints that fees charged for transfers 
of records have been unreasonable. This practice prevents consumers 
from making such transfers and obtaining medical care with the best 
quality medical data. The regulation does intend to control such 
charges in order to ensure access by patients to their films but the 
final rule does not require facilities to absorb additional expenses. 
Instead, each facility that decides to charge consumers for this 
service must limit its charges to documented costs.
    (Comment 434). Nine comments stated that original mammograms should 
be provided by other facilities for comparison purposes free of charge 
as a courtesy among institutions.
    FDA supports this process; the final regulations do not mandate a 
charge. However, if any fee is established, FDA's regulation requires 
that it not exceed costs of transfers of such records.
    (Comment 435). Two comments suggested that FDA's regulations should 
consider future technology, which may include the electronic transfer 
of films.
    FDA regulations are for screen-film and xeromammography. As other 
technology is approved for medical use, alternative standards under the 
MQSA will be issued.
    (Comment 436). One comment asked if a facility must retain a series 
of mammography records for 10 years and discard them as each record is 
10 years old, or discard them when the oldest record is 10 years old. 
FDA interprets the provision in the MQSA to mean that, if there is a 
series of mammograms for a patient, the oldest mammogram of the series 
can be 5 years old. If there is only one mammogram for a patient, it 
must be kept 10 years unless a transfer is requested. One comment 
stated that mammograms should be maintained for longer than 10 years if 
mandated by State or local law. In fact, the MQSA mandates this and FDA 
has written its regulations to conform to this provision.
    (Comment 437). Two comments recommended that mammograms be kept 
indefinitely in order to spare a patient an unnecessary biopsy and 
another comment recommended that FDA establish a standard retention 
period of 5 to 7 years.
    The final regulations do not preclude facilities from keeping 
mammograms longer than what is required by the statute as a minimum. 
However, the agency rejects the 5 to 7 year standard because the 
timeframes set forth in the regulation are prescribed by the statute.
    (Comment 438). One comment recommended that FDA reinstate a HCFA 
requirement that previous mammograms be obtained for comparison with 
present films.
    FDA believes that this is good medical practice, but it is not an 
appropriate focus for FDA regulations under the MQSA.
    f. Mammographic image identification (Sec. 900.12(c)(5)) 
    This provision describes the elements that must be included on any 
mammography film to identify the image. They are: patient identifier, 
date of examination, view, laterality, facility identification, 
technologist identification, cassette/screen identification, and unit 
identification, if the facility has more than one unit.
    The NMQAAC advised FDA that these elements need to be present on 
all mammogram films to ensure proper patient care. FDA agrees. These 
are the same elements as those established by Sec. 900.4(c)(2)(viii) to 
identify films submitted to accreditation bodies for clinical image 
review. Comments received from the public relating to these elements 
for film identification are addressed in that section of the preamble 
that discusses Sec. 900.4(c)(2)(viii).
4. Quality Assurance--General (Sec. 900.12(d))
    This paragraph was intended to identify the individuals responsible 
for the actions required by Sec. 900.12(e) and (f), including those 
intended to ensure that safe radiation dose levels were used. With one 
or two exceptions, the requirements of this paragraph were included in 
the ACR quality assurance manuals that were made part of the interim 
regulations by reference. The ACR manuals are not referenced in the 
final regulations. However, certain significant aspects of those 
manuals, such as the requirements in this section, were incorporated 
into the proposal because there is broad agreement that these 
principles are basic to a good quality assurance program.
    a. General comments on quality assurance
    (Comment 439). Two comments stated that all facilities should 
follow the same set of universal guidelines to maintain the same 
quality of results.
    FDA notes that the MQSA and the implementing regulations are 
designed to require that facilities meet universal minimum standards. 
Nothing in the statute or regulations is intended to prevent a facility 
from applying additional, more stringent standards or procedures that 
strengthen QC at that facility.
    (Comment 440). One comment stated that FDA should eliminate this 
entire paragraph except for a single provision that would require each 
facility to have a quality assurance manual and to verify, through the 
signature of a responsible official, that the manual is followed.
    FDA does not believe that the general requirement suggested by the 
comment would effectively establish minimum levels of quality assurance 
at all facilities.

[[Page 55934]]

    b. Responsible individuals (Sec. 900.12(d)(1)) 
    This paragraph identified the responsibilities of the individuals 
associated with the quality assurance program.
    (Comment 441). Two comments recommended that FDA be more specific 
about what responsibilities should be listed and to whom they should be 
assigned.
    FDA does not believe that additional detail will be useful in these 
provisions. Greater specificity would limit the facility's flexibility 
to design a quality assurance program that best meets its individual 
needs and to quickly change its program in response to changes in 
circumstances or technology.
    (Comment 442). One comment expressed the author's disappointment 
that this section and the rest of the regulations failed to allot any 
responsibility to administrators and Chief Executive Officers (CEO's), 
who have the authority to make the decisions that control quality but 
seem to be more motivated by financial concerns.
    FDA agrees that administrators, CEO's, owners, and operators of 
facilities share responsibility for the quality of mammography at their 
facilities. However, individuals working more directly in and with the 
mammography facility on a daily basis often are better able to 
determine when quality problems exist and how to correct them. The 
agency recognizes that it is sometimes difficult for the staff to 
obtain the administrator's support for necessary actions. Nevertheless, 
if necessary actions are not taken to correct quality assurance 
defects, the result could be sanctions against the facility by FDA. 
Because such sanctions can affect the reputation and profitability of 
any facility, FDA believes that administrators and CEO's will cooperate 
to support actions to improve or maintain mammography quality.
    c. Lead interpreting physician (Sec. 900.12(d)(1)(i))
    This provision requires facilities to identify a lead interpreting 
physician to have the general responsibility for ensuring that the 
quality assurance requirements of Sec. 900.12(d) through (f) are met. 
This is a change from the interim regulations, which assigned this 
responsibility to a mammography medical physicist. This change drew a 
number of almost evenly divided comments.
    (Comment 443). Eleven comments plus NMQAAC supported the change. 
Various comments pointed out that the medical physicist often does not 
have the authority to implement needed actions, especially if he or she 
is a contract physicist who is rarely at the facility, and the medical 
physicist usually does not have the expertise to deal with nonequipment 
issues. One comment noted that Massachusetts' regulations have a 
similar provision to the proposal and it had been found to improve the 
quality assurance programs.
    Eleven other comments opposed the change. Some of these comments 
stated the belief that interpreting physicians did not have sufficient 
knowledge of or interest in quality assurance to properly handle this 
responsibility. Others said that, in modern medicine, the physicians 
also lack authority to implement necessary changes and pointed out that 
interpreting physicians may also be contract employees and not actually 
at the facility. A related comment warned that, if the interpreting 
physician is to be given responsibility for oversight, he or she must 
also have authority to institute necessary changes. One comment stated 
that while it is important to have an interpreting physician in this 
role, it is more important to assign this responsibility to someone at 
the facility, even if it means involving a nonphysician. Another 
comment questioned the basis for designating a lead interpreting 
physician if he or she can assign their responsibilities to other 
people. Two comments suggested that wording be changed to allow each 
individual facility to decide who would be most appropriate for this 
responsibility. Finally, one comment stated that the MQSA specifically 
said that the medical physicist was to have responsibility for the 
quality assurance program.
    After considering all these comments, FDA has decided to leave this 
responsibility in the hands of an interpreting physician, as proposed. 
Because the interpreting physician is the final arbiter of the quality 
of a mammogram, it is logical that the responsibility for the quality 
assurance program rest with an interpreting physician. The agency 
recognizes that interpreting physicians in some facilities face the 
same limitations on their authority as medical physicists. However, FDA 
believes that an interpreting physician is more likely to have adequate 
authority, or the ability to influence those that do, than a medical 
physicist. The agency also recognizes that the interpreting physicians 
may not be located at the facility itself. Even in those circumstances, 
interpreting physicians have more regular interaction with the facility 
through their mammography interpretations than do contract medical 
physicists conducting annual surveys. Again, the agency realizes that 
interpreting physicians may not have the knowledge to carry out all 
aspects of the program themselves, but notes that this is likely to be 
true of any other individual in this position. For this reason, the 
final regulations do not require the lead interpreting physician to 
perform all of the duties personally, but rather to see that they are 
carried out in such a way as to meet the requirements. The basic 
responsibility remains with the interpreting physician, even if some or 
all individual duties are delegated to people with specific training to 
carry them out. Contrary to the opinion expressed in one comment, 
identifying a lead interpreting physician is valuable because it 
assigns this basic responsibility and establishes accountability even 
when tasks are delegated.
    Many important duties will be delegated to the medical physicist. 
FDA is aware, as one comment noted, of the MQSA provision that requires 
the medical physicist to ``survey mammography equipment and oversee 
quality assurance practices at each facility'' (42 U.S.C. 
263b(f)(1)(F)). As noted above, the interim regulations did assign to 
the medical physicist the overall responsibility for quality assurance. 
FDA's experience under the interim regulations, however, established 
that the interpreting physician, who ordinarily has more interaction 
with the facility and is more likely to be onsite, also has an 
important role in the oversight of quality assurance. As discussed, 
members of NMQAAC and public comments pointed out problems with the 
medical physicist having the primary responsibility for all quality 
assurance at the facility. After evaluating its experience and the 
comments, the agency proposed, and now intends, to shift overall 
responsibility for the quality assurance program to the lead 
interpreting physician. The medical physicist will continue to do the 
annual survey and oversee quality assurance practices, especially those 
related to the equipment, as required by the MQSA and the agency 
expects that the physicist's expertise will inform all final decisions 
that are made on quality assurance issues. The final regulation, 
however, requires additional oversight through the lead interpreting 
physician. FDA believes this change from the interim regulations is in 
accordance with its general authority to require the facility to 
establish an effective quality assurance program (42 U.S.C. 
263b(f)(1)(A)).

[[Page 55935]]

    Section 900.12(d)(1)(i) requires the lead interpreting physician to 
determine whether individuals assigned to quality assurance 
responsibilities are qualified to carry them out. FDA agrees with the 
comment that urged that the lead interpreting physician also be given 
authority to make needed changes because effective quality assurance 
will require facilities to respond appropriately to situations that 
need improvement or correction. Internal administrative and budgetary 
decisions, however, are beyond FDA's authority and the agency cannot 
control the business and management relationships that will affect any 
lead interpreting physician's ability to institute change.
    d. Interpreting physicians (Sec. 900.12(d)(1)(ii))
    This paragraph was intended to emphasize the role that all 
interpreting physicians should play in establishing and maintaining 
quality mammography at a facility. As previously mentioned, the 
interpreting physicians are the final arbiters of the quality of 
mammography images. It is important that they communicate their 
satisfaction or dissatisfaction with the quality of the images they are 
provided to interpret to the technologists who produced them. Such 
communication is the crucial first step in the identification of 
problems and the initiation of corrective actions. FDA is aware that 
this communication has not always occurred in the past, especially if 
the interpreting physicians are not located at the facility. Media 
investigations and many anecdotal accounts have illustrated this 
failure in communication.
    None of the 17 comments on this provision disagreed with the basic 
premise that interpreting physicians should provide feedback to 
facility staff producing the mammograms. However, there were some 
misunderstandings as to just what was required.
    (Comment 444). In particular, 13 comments mistakingly assumed that 
each interpreting physician was required to contact every technologist 
about the quality of each film taken. These comments requested that the 
requirement be limited to reporting technically inadequate mammograms 
to the QC technologist. Another comment pronounced the requirement as 
excellent, but asked whether a report was required on the 
technologist's performance for every film or if a summary of each 
technologist's performance was sufficient. Another comment suggested 
that feedback be given to the lead interpreting physician or, in his or 
her absence, to the QC technologist. One comment requested that this 
provision be more specific, and another recommended that all 
interpreting physicians be required to have training in the technical 
aspects of mammography, quality assurance, and QC.
    FDA drafted the proposed regulation to be general in order to give 
each facility the flexibility to design a feedback system that best 
fits its own situation. The agency believes this flexibility should be 
retained in the final regulations. In response to the comments, 
however, FDA has clarified that followup activities by interpreting 
physicians are required only when the image is of poor quality. FDA 
recommends, however, that positive feedback also be given when 
warranted because such feedback is an effective incentive for 
maintaining quality performance.
    e. Medical physicists (Sec. 900.12(d)(1)(iii)) 
    This paragraph summarizes the role of the medical physicist in 
establishing and maintaining quality mammography.
    (Comment 445). Eleven of the comments received on this provision 
suggested various wording changes. Seven of these supported changes 
that would state that the physicist is to evaluate the equipment and to 
survey it. An eighth comment wanted to amend the language to give the 
medical physicist authority to take necessary steps to ensure quality 
in his or her area of responsibility. Two comments suggested changes 
that would limit the physicist's responsibilities to overseeing the 
equipment-related quality assurance practices. These comments further 
suggested limiting the physicist's review of the QC technologist's work 
to verifying that it is performed and not to include providing advice 
on tests or suggestions for corrective measures. Another comment, 
however, clearly disagreed with this point of view and stated that the 
medical physicists should be required to oversee the facility's entire 
quality assurance program.
    FDA agrees that the physicist should be involved in equipment 
evaluation and the annual survey and notes that changes made elsewhere, 
in the survey definition and in Sec. 900.12(e), will achieve this goal. 
FDA cannot require that the medical physicist be given authority to 
initiate changes at the facility to improve quality for the same 
reasons that it did not issue regulations giving the lead interpreting 
physician similar administrative and budgeting authority. The agency 
does agrees that the physicist's oversight responsibility should be 
focused primarily on the equipment-related areas. The definition of the 
position of lead interpreting physician in Sec. 900.12(d)(1)(i), as 
discussed previously, should clarify that general overall 
responsibility rests with that physician while responsibility for 
equipment-related matters resides with the physicist. FDA does not 
agree with the suggestion that would limit the medical physicist's role 
in the oversight of the QC program to merely verifying that the 
technologist's work was done. The agency believes that, as the 
equipment and imaging physics expert, the physicist's role must be more 
active and that ensuring an adequate QC program clearly should be part 
of the medical physicist's duties. The medical physicist should not 
stop with verifying that the QC tests were performed but should also 
ensure that they were performed properly, that the results were 
analyzed, and that any problems detected by the analysis were 
corrected.
    (Comment 446). A final comment on this paragraph suggested that a 
new intermediate position be created at a level between the QC 
technologist and the physicist. The comment recommended that the person 
in this position could do tests that do not require a physicist but are 
beyond a technologist's training, and noted that such a position has 
been quite useful in the respondent's facility.
    Provisions of Sec. 900.12(e) require that surveys and mammography 
equipment evaluations be performed by medical physicists. Under the 
interim or final regulations, a facility is free to create an 
intermediate position for personnel to perform other testing during the 
time periods between the surveys and evaluations, including performance 
of the tests normally done during surveys. However, the agency does not 
have sufficient evidence to demonstrate that it would be beneficial to 
make this a general requirement and believes each facility is in the 
best position to decide whether such a position would be of value in 
its situation.
    f. QC technologist (Sec. 900.12(d)(1)(iv)) 
    This provision describes the QC technologist's responsibility to 
perform all quality assurance duties not assigned to the lead 
interpreting physician or the mammography medical physicist. The main 
issue raised by the comments on this provision was about the 
qualifications of the individual holding this position.
    (Comment 447). Eighteen comments expressed the opinion that the 
person doing these tests should be a radiologic technologist who meets 
all of the requirements necessary to perform mammography examinations. 
Seven additional comments stated that the QC technologist should be a 
technologist but, to increase flexibility for the

[[Page 55936]]

facility, should not necessarily have to be qualified to do mammography 
examinations. One of these seven recommended that the QC technologist 
should have some training in mammography. Ten comments argued that the 
individual performing at least some of the tests did not even have to 
be a technologist, as long as that person had training in the test 
performance. Some of these pointed out that requiring a technologist to 
do the tests would increase facility costs without an equivalent 
increase in the quality of mammography.
    After considering the comments, FDA has revised the proposal to 
permit nontechnologists to perform tasks for which they were trained, 
as long as their work is supervised by a QC technologist who meets the 
requirements to do mammography examinations. FDA believes this change 
strikes the proper balance between the need for expert oversight and 
the need to reduce unnecessary costs for facilities.
    NMQAAC discussed this issue at several meetings and, at different 
times, expressed varying points of view. However, after its own review 
of the public comments, NMQAAC supported the approach FDA has taken in 
the final rule.
    (Comment 448). Twelve comments suggested changes, primarily to 
allow or prohibit the facility from having more than one QC 
technologist.
    FDA agrees that there are advantages to the consistency that can be 
achieved if there is only one QC technologist. The agency also 
recognizes that the facility may find it useful and necessary to have 
more than one QC technologist, e.g., to ensure coverage when one QC 
technologist is ill or on leave. The agency notes that facilities also 
have the option of having the lead interpreting physician or medical 
physicist fill in for the QC technologist, assuming they have the 
necessary qualifications, by temporarily ``reassigning'' the 
technologist's duties.
    (Comment 449). Another comment suggested that the QC technologist 
should report directly to the lead interpreting physician rather than 
to the medical physicist.
    FDA notes that the regulations permit the facility to decide for 
itself what lines of communication to the lead interpreting physician 
should be established. The agency believes that this flexibility should 
be retained.
    (Comment 450). Another comment suggested that all mammographers 
should be trained in all QC tests and procedures.
    From the context of the comment, it was clear that the author was 
using the term ``mammographer'' to refer to technologists doing 
mammography, and not, as is becoming increasingly common, to 
interpreting physicians interpreting mammography. Section 
900.12(a)(2)(ii)(A) does require such training as part of initial 
training for technologists who will begin performing mammography after 
the final regulations become effective. Training in these areas could 
also be used to fulfill initial requirements under the interim 
regulations, so many technologists presently doing mammography will 
have had this training. Although FDA encourages all radiologic 
technologists currently practicing to include such training as part of 
their continuing education, the agency does not believe that the 
benefits of retroactively requiring all present technologists to 
receive this training would outweigh the costs.
    (Comment 451). A final comment suggested that adequate time should 
be allotted for the quality assurance/QC duties.
    FDA fully agrees with this comment but does not believe that this 
kind of commitment can be codified through a regulation. The agency 
also notes that the amount of time needed will vary significantly, in 
view of the different situations in different facilities and the 
differing abilities of the individual QC technologists. As discussed in 
connection with earlier sections, FDA believes that owners, operators, 
and managers will have new incentives to ensure that quality assurance 
programs are properly implemented and that these programs meet the 
Federal standards with which all facilities must comply.
    g. Quality assurance records (Sec. 900.12(d)(2))
    The provisions of this paragraph have been significantly changed 
from the proposal. The proposal required that the facility have a 
quality assurance manual covering the procedures to be used in meeting 
the requirements of Sec. 900.12(e) and (f). The manual was to be 
readily available to all staff members and documentation that it was 
read and approved by the lead interpreting physician and the medical 
physicist was required. A list of individuals assigned quality 
assurance responsibilities and details of their assignments was also to 
be available to all staff members. Records were to be kept showing that 
these individuals were qualified for their assigned duties. Records 
were also to be kept showing the data obtained during monitoring of the 
facility performance, the analysis of the monitoring data, the problems 
detected and corrective actions carried out, and the effectiveness of 
the corrective actions in resolving the problems. The records were to 
be kept for each test for a minimum of 1 year or until the test had 
been performed two additional times at the required frequency, 
whichever was longer.
    In response to comments received, as summarized below, and in 
keeping with the FDA's goal of less prescriptive and more flexible 
regulations, this paragraph has been greatly simplified. The final 
regulations do not require any description of the procedures to be 
followed in performing the QC tests or a list of the individuals with 
quality assurance responsibilities and their responsibilities. The 
proposal requiring records documenting the qualifications of these 
individuals to perform their duties is changed to simply require that 
records be kept concerning employee qualifications. No review, 
revision, or sign-off of the manual is required at any frequency but 
there is a general requirement that the lead interpreting physician, a 
QC technologist, and a medical physicist are to ensure that records are 
maintained and updated. The time that the records of testing and 
followup actions must be kept has been clarified but remains 
essentially the same.
    The proposal divided the provisions of Sec. 900.12(d)(2) into four 
paragraphs, (i) through (iv). As a result of these changes, paragraphs 
are no longer needed but the comments received on the proposed four 
paragraphs will be discussed, following the general comments.
    h. General comments on quality assurance records
    (Comment 452). One comment asserted that keeping quality assurance 
records was an unnecessary burden but did not suggest an alternative 
means by which a facility could demonstrate that it had carried out the 
quality assurance tests and all necessary followup activities. A second 
comment recommended that mammography facilities be required to retain 
written specifications in a standardized format from the processor 
manufacturer.
    FDA cannot accept the first of these comments without an adequate 
alternative to keeping records. FDA agrees there would be value in 
processor manufacturers providing specifications in a standardized 
format but believes it would be premature to make this a requirement. 
The agency's previous attempts to encourage the provision of processor 
operating characteristics for different types of film showed that there 
are significant problems to be solved, among them the very large number 
of

[[Page 55937]]

possible combinations of film, chemistry, and processors.
    i. Records to be kept (proposed Sec. 900.12(d)(2)(i), (ii), and 
(iii))
    (Comment 453). A few comments were received on the records to be 
kept. Three comments opposed the change from requiring the use of the 
ACR manual to allowing the use of whatever manual best fits the 
facility's needs.
    FDA believes that the increased flexibility provided by allowing 
the use of manuals other than the ACR manuals is desirable because it 
permits facilities to more rapidly adjust their programs to incorporate 
improvements in quality assurance procedures or new techniques for new 
technology. When a manual is specified in regulations, the regulations 
may have to be amended to facilitate use of even a new edition of that 
manual, let alone an improved manual from another source. To increase 
flexibility even further, in the final rule FDA has dropped the use of 
the word ``manual'' altogether because it seemed to imply a certain 
format. Facilities will now be able to keep the required records in any 
suitable format.
    (Comment 454). A number of comments recommended addition of items 
to the list of those required to be kept. Six comments suggested adding 
technique charts to the required records, while a seventh suggested 
adding documents related to the medical outcomes audit program. Another 
comment stated that documentation for darkroom cleaning, screens, and 
view boxes should not be eliminated.
    NMQAAC members pointed out that there was already a requirement in 
the ACR manuals, which were incorporated into the interim regulations 
by reference, that a technique chart be available. Although there was 
some difference of opinion, NMQAAC seemed to support retaining a 
requirement for keeping a technique chart with the equipment but not 
necessarily in the manual. With respect to the quality assurance manual 
in general, the view of NMQAAC seemed to be that elements required in 
the final regulations were ``key'' or ``basic'' to the success of a 
quality assurance program. At least one NMQAAC member expressed 
reservations about the detail required and would have preferred to 
limit the regulation to a general requirement that there be a quality 
assurance manual. However, both this member and a second member 
recognized that enforcement by inspectors would be difficult without 
more detailed requirements.
    FDA notes that documentation of facility cleanliness activities is 
required in Sec. 900.12(e)(11). The list of other records that must be 
kept, although not necessarily in a ``manual,'' has been revised as 
discussed previously.
    (Comment 455). Other issues that drew a number of comments were who 
should sign off on the manual and how often should review, revision, 
and sign-off take place. Nine comments supported having the QC 
technologist sign-off in addition to the lead interpreting physician 
and mammography medical physicist. A tenth comment would limit the 
physicist sign-off to only those items related to his or her 
responsibility. Three comments stated that the review, revision, and 
sign-off should occur at least annually. NMQAAC supported both adding 
the QC technologist to the sign-off list and the annual review, 
revision, and sign-off.
    FDA has replaced the requirement for a formal sign-off with a 
general statement that the lead interpreting physician, QC 
technologist, and medical physician should ensure that the specified 
records are kept.
    (Comment 456). Another comment stated that qualifications of the 
individuals assigned responsibilities in the QC program should be kept 
on record only if those individuals are not listed in the facility's 
application (presumably for accreditation).
    FDA disagrees with this comment. The accreditation bodies do not 
check the qualifications of personnel to perform quality assurance 
tasks during the accreditation process.
    Proposed Sec. 900.12(d)(2)(ii), which required that a list be kept 
of the individuals with quality assurance assignments and their 
assignments, drew only one comment. The comment supported the list but 
urged that the requirement be clarified so it was not construed to mean 
that only the listed individuals could carry out the duties. As 
discussed above, FDA has eliminated this proposed requirement.
    The only comment on the proposal for keeping records of 
qualifications of quality assurance personnel, Sec. 900.12(d)(2)(iii), 
suggested that those records should be kept indefinitely. As discussed 
above, FDA has reworded the requirement slightly. Requirements for 
record retention are discussed below.
    j. Monitoring performance (proposed Sec. 900.12(d)(2)(iv))
    As proposed, this provision would have required facilities to 
maintain records related to monitoring of their facility's performance 
for 1 year or until the tests has been performed two additional times 
at the required frequency, whichever was longer.
    (Comment 457). One comment stated that the words ``for a minimum of 
1 year'' should be replaced with ``from inspection-to-inspection'' 
because inspections may not occur precisely at annual intervals. FDA 
has changed the wording to ``until the next annual inspection has been 
completed and FDA has determined the facility is in compliance with the 
quality assurance requirements.'' This change addresses concerns raised 
by this comment and clarifies that an inspection includes the followup 
and the actual visit to the facility.
    5. Quality Assurance--Equipment (Sec. 900.12(e))
    The primary purpose of the equipment aspects of the quality 
assurance program is to prevent problems with equipment or detect and 
correct problems before they can have a significant effect on clinical 
image quality. In order to achieve this objective, the performance 
parameters of the equipment must be tested at appropriate frequencies, 
the test results must be analyzed promptly to determine if the 
performance of the equipment is satisfactory, and any identified 
problem must be corrected as soon as possible. Followup tests must also 
be conducted to determine whether the corrective actions were effective 
and adequate. Requirements for the types of equipment tests to be 
performed and for the necessary followup actions were proposed in 
Sec. 900.12(e). These requirements have generally been retained in the 
final rule. However, on the basis of a number of valuable comments the 
agency received in response to its proposals, some revisions to the 
proposal have been made. Many of the revisions have been made after 
discussions with NMQAAC. In addition, tests for radiation output and 
decompression have been added to the annual QC tests as 
Sec. 900.12(e)(5)(x) and (xi). The action limits for these tests were 
proposed as equipment specifications in Sec. 900.12(b).
    a. General comments on equipment quality assurance
    In the preamble to the proposal (61 FR 14912), FDA specifically 
requested comments on the value of a simple daily total system test 
based upon the evaluation of the optical density and artifacts on an 
image of a uniform phantom. The agency believed that the total system 
test, when performed in conjunction with the processor performance test 
set forth in Sec. 900.12(e)(1), would ensure the overall quality of X-
ray machine and processor performance and of the films produced. This 
test would only takes a few minutes to perform and records of the test 
would enable a medical physicist to

[[Page 55938]]

quickly detect the source of a problem when it occurs.
    (Comment 458). A large number of comments opposed the idea of such 
a test. Several of these comments, however, confused this test with the 
alternative phantom testing identified earlier as a possible basis for 
performance-based standards (See 61 FR 14860). Some members of NMQAAC 
also opposed this test. The agency also received a number of comments 
supporting this test. Several comments agreed that more frequent 
phantom testing in conjunction with daily processor testing is 
important.
    In view of the mixed comments, FDA concluded that it should not 
require the test until it gathers additional data on its usefulness. 
However, FDA strongly encourages facilities to test their machines as 
frequently as possible, either by a phantom evaluation or by the total 
system test.
    A number of comments requested that FDA provide a detailed 
description of all QC test procedures. Several comments wanted FDA to 
reference ACR QC manual, while some comments considered the proposed 
Quality Assurance-Equipment requirements to be appropriate.
    FDA notes that Sec. 900.12(e)(1) through (e)(5) lists the minimum 
performance tests to be conducted on screen-film systems and their 
required frequency. Action limits for the tests are also specified. The 
agency has refrained from providing extensive detailed requirements or 
prescriptive descriptions of test procedures, as some comments 
recommended, in order to provide facilities with the flexibility to use 
their own judgment as to what testing methods best enable them to meet 
the required criteria. FDA has also decided not to base its QC 
requirements on a single manual and, therefore, no such manual has been 
referenced. In addition, NMQAAC has advised FDA that the ACR manuals 
were intended to be used as guidelines, not in a prescriptive manner. A 
facility may consult any appropriate manual on agency guidance to meet 
the requirements in Sec. 900.12(e)(1) through (e)(5).
    (Comment 459). One comment stated that some of the tests should be 
more rigorous. The comment further questioned why a monthly visual 
checklist was not included.
    While conducting regular visual checks of the equipment is a 
desirable practice, it is not an action that can be confirmed from test 
data. Therefore, the agency has decided to encourage this and similar 
desirable practices through educational means instead of making them 
regulatory requirements.
    (Comment 460). Another comment stated that FDA should only issue 
more stringent requirements if their benefits clearly exceed their 
costs.
    FDA agrees with this comment and believes that the tests it has 
required meet this criterion.
    (Comment 461). One comment stated that numerous paragraphs refer to 
films, optical densities, and processors, without limiting the 
requirements to any specific modality.
    FDA notes that the initial words in each paragraph from 
Sec. 900.12(e)(1) to (e)(5) are ``Facilities with screen-films shall * 
* *,'' making it clear what modality is referred to.
    (Comment 462). Another comment maintained that FDA should require 
proper QC tests for stereotactic units. One comment stated that the 
quality assurance standards should include a requirement to use a 
digital mammography evaluation phantom developed by the author's 
company that has been designed specifically for QC of digital machines 
for stereotactic biopsy.
    Interventional mammography is presently exempt from the MQSA 
requirements for reasons discussed in response to the comments on the 
definition of mammography in Sec. 900.2(y). The agency is in the 
process of developing quality standards for interventional mammography 
and these will include QC tests. QC tests for other mammographic 
modalities have been addressed in Sec. 900.12(e)(6).
    (Comment 463). Another comment stated that FDA should provide its 
inspectors with more latitude to accept variations from regular 
inspection procedures, if the physicist can adequately explain the 
rationale for the deviations and demonstrate how the standard is met. 
From the context, the agency assumes that the author of the comment is 
actually referring to survey procedures rather than inspection 
procedures.
    FDA has instructed inspectors to discuss variations with QC 
personnel or medical physicists available in the facility during 
inspection. In some cases, the inspectors, after receiving satisfactory 
explanations for variances in test procedures, have refrained from 
giving citations or withdrawn citations initially given to the facility 
during inspection. However, because it is essential that the 
evaluations of facility conformance with the quality standards be 
consistent nationwide, the latitude provided to inspectors necessarily 
has to be limited. Moreover, those wishing to use alternatives to the 
requirements of the regulations who can demonstrate that their 
alternative provides assurance of quality mammography equal to the 
regulatory requirement, may do so in accordance with Sec. 900.18.
    (Comment 464). A few comments urged FDA to require testing with all 
cassettes wherever that is appropriate.
    In the proposed regulations, the agency proposed that screen speed 
uniformity of all cassettes in the facility be tested. In the final 
regulations, FDA added that artifact evaluations should be performed 
with all cassettes in the facility. The agency also considered 
requiring performance of the phantom image quality test with all sizes 
of image receptors. However, when FDA staff members carried out phantom 
image evaluations using two different image receptor and cassette sizes 
with five different mammography machines, no difference was seen in the 
phantom image scores when results with larger image receptors were 
compared to those with smaller. NMQAAC strongly advided FDA not to 
require weekly phantom testing for all image receptor sizes because the 
members do not believe that phantom image quality is affected by 
receptor size. NMQAAC pointed out that the ACR manual did not recommend 
phantom image evaluation with large image receptor sizes. Based on all 
this information, the agency concluded that facilities should not be 
required to conduct phantom image quality tests with all available 
sizes of image receptors.
    b. Daily QC tests--screen-film system (Sec. 900.12(e)(1))
    The only daily tests required under the final regulations are those 
that ensure adequate processor performance by assessing base plus fog 
density, mid density, and density difference, using mammography films 
used clinically at the facility.
    (Comment 465). Five comments stated that there should be a maximum 
limit between time of exposure and time of processing. NMQAAC discussed 
this issue in connection with requirements for mobile units, for which 
image degradation due to delayed processing is a particular concern. 
The committee concluded that, in general, this was not a significant 
enough problem to require a regulatory requirement and FDA accepted 
this position.
    (Comment 466). Ten comments suggested the word ``examinations'' 
should be replaced with ``films'' and the word ``performed'' with 
``processed.'' The agency agrees with these comments and has made such 
changes in the final regulations.
    One comment suggested adding the words ``and evaluate'' after 
``shall perform.''

[[Page 55939]]

    FDA notes that Sec. 900.12(e)(8) generally defines tests for which 
the evaluation of test results (and corrective actions) must be 
performed before further examinations are conducted. The processor 
tests are among them.
    (Comment 467). Several comments suggested that the last few words 
in Sec. 900.12(e)(8)(ii), ``of no less * * * 1.2 OD, [optical 
density]'' should be deleted. These comments stated that in some cases, 
the step averages may turn out to be lower, for example 1.05, and that 
should be acceptable if the next higher step shows a substantially 
higher OD, such as 1.4. Another comment offered a similar argument, 
noting that the proposed rules would not allow the use of modern high 
gradient mammography films where the change in optical density between 
adjacent steps in this density range can be as high as 0.7.
    FDA agrees with these comments and has deleted ``of no less * * * 
1.2 OD'' in Sec. 900.12(e)(8)(ii).
    (Comment 468). One comment stated that QC measures should be in 
place for densitometry and sensitometry equipment.
    FDA requires all sensitometers and densitometers its inspectors use 
to be properly calibrated. If FDA inspectors detect problems in the 
processor performance, the facility will have to identify the cause. If 
the cause turns out to be related to inadequate performance of the 
facility's sensitometry or densitometry equipment, the effort required 
to determine the nature of the problem will give the facility 
sufficient incentive to take actions to avoid a recurrence without the 
need for a regulatory requirement.
    (Comment 469). Three comments asserted that the  0.15 
OD action limits for mid-density and density difference were too 
restrictive as proposed and requested changing this limit to allow a 
wider range.
    Under the interim regulations, facilities have been required to 
comply with this limit and the inspection data reveal that most 
facilities are able to do so. The agency does not find that there is 
adequate reason for changing this limit in the final regulation.
    (Comment 470). One comment stated that a guidance document should 
be published to provide a clear explanation of the scientific basis for 
establishing an H&D curve and the importance of parameters taken from 
this curve to monitor trends in processor QC.
    FDA believes that this is a widely accepted practice and the most 
effective procedure that is currently available. Sufficient materials 
providing the type of guidance requested already exist.
    c. Weekly QC tests--screen-film system (Sec. 900.12(e)(2))
    In the proposal, the image quality test using a phantom approved by 
FDA, which was required monthly by the interim regulations, was made a 
weekly test.
    (Comment 471). Twenty comments opposed changing the phantom testing 
from monthly to weekly, arguing that the additional cost of performing 
phantom image evaluation weekly would be burdensome to many facilities. 
However, a larger number of comments supported this change, many 
indicating that their facility already performs phantom tests weekly.
    FDA is convinced by the experience of the facilities that have been 
performing phantom image evaluation at a higher frequency that the test 
should be performed weekly. The agency believes that the benefit 
outweighs a slight increase in costs. As noted in the preamble to the 
proposal, if the daily total system test had been required, returning 
the required frequency of the image quality test to monthly could have 
been justified. However, because FDA is not mandating the total system 
test at this time, it is essential that all facilities perform weekly 
phantom image evaluation as an overall assessment of all aspects of the 
imaging chain.
    (Comment 472). Some comments suggested changing ``image contrast'' 
to ``density difference'' and ``assess density difference'' to ``assess 
image contrast'' in Sec. 900.12(e)(2)(iv).
    The agency agrees with these comments and has revised the wording.
    (Comment 473). One comment stated that the density difference 
between the background and the test object needs to be defined. The 
comment further stated that there is presently confusion over the ACR 
recommendation for a density difference of 0.40 at 28 kVp.
    FDA notes that, with the changes made as suggested by the previous 
comments, it is clear that the density difference is measured between 
the background and a test object added to the phantom to assess the 
image contrast. The agency has determined that the regulations should 
not specify a number for the operating level for this density 
difference, specify the test objects, or prescribe any technique 
factors to achieve the desired operating level, because all these 
variables may change with future changes in technology. However, FDA 
considers it important that facilities make sure that the measured 
density does not vary by more than  0.05 from the 
established operating level.
    (Comment 474). Several comments considered the requirement of a 
minimum 1.20 optical density (OD) at the center of a phantom image to 
be high and believed that many facilities will not be able to meet that 
standard. One comment stated that higher OD is achieved at the expense 
of patient dose. Some comments considered 1.20 OD too low. One comment 
recommended that there be an upper limit of OD. Another comment stated 
that OD within  0.20 is reasonable if the film 
manufacturer's tolerance is better than 0.3 OD from batch to batch.
    FDA believes that proper OD is vital to the early detection of 
micro calcifications and, with the advent of new mammography screen-
film systems, an OD of 1.2 with a variation of no more than 15 percent 
can be achieved if the processors and the units perform properly. 
NMQAAC also advised FDA to require that the film OD at the center of 
the phantom image be no less than 1.2 for the purposes of this test. 
The agency, however, believes that a requirement for an upper limit on 
OD may hinder any future development of mammography screen-film 
systems. Therefore, the agency will retain Sec. 900.12(e)(2)(i) and 
(ii) as proposed.
    (Comment 475). One comment stated that the point of the image 
quality test is to determine constancy; therefore, it was unnecessary 
to mandate the measuring position of optical density as the center of 
the image, as long as the same location is measured each time.
    The intention of this requirement is that the OD be measured at the 
same location of the phantom image each time, as the comment suggested. 
The agency believes that the center of the phantom image is a 
reasonable and easy place to locate such measurements. Further, it is 
not advisable to measure OD too far away from the center towards the 
anode side of the phantom image in order to avoid a decrease in density 
due to the heel effect. This could lead to a failure to meet the 
 1.2 OD requirement when it might have been met if measured 
at the center of the same phantom image.
    (Comment 476). One comment recommended that Sec. 900.12(e)(2)(iv), 
the phantom image contrast requirement, be deleted because daily film 
sensitometry already measures this parameter.
    FDA disagrees. The daily sensitometry test only uses light that 
simulates the screen phosphor luminescence. However, emitted light due 
to X-ray induced fluorescence from the screen phosphors is different 
both in spectral dependance and in intensity from the light output from 
the currently available sensitometry equipment. It is

[[Page 55940]]

very important that contrast is evaluated when the film is exposed by 
the emitted light from the actual screen phosphors, induced by the X-
ray beam. For this reason, the daily film sensitometry test cannot 
replace this test of image contrast.
    (Comment 477). Several comments noted that the current phantoms are 
not tissue equivalent and recommended that FDA specify only one type of 
phantom and minimum acceptable performance criteria. A related comment 
urged FDA to provide guidance to establish the adequacy of image 
quality. Another comment requested specification of the test object and 
measurement conditions for phantom evaluation.
    FDA has refrained from specifying phantom or test object type, 
performance criteria, or scoring methodology in order not to inhibit 
future advances in phantom technology. The agency continues to believe 
that accreditation bodies should establish phantom specifications and 
related performance criteria. However, as part of its responsibilities 
for accreditation body approval and oversight, FDA will examine each 
body's phantom specification and performance requirements, which will 
have to be substantially the same among the different accreditation 
bodies.
    d. Quarterly QC tests (Sec. 900.12(e)(3))
    Two QC tests were required to be performed quarterly in the 
proposal. These were a test of the fixer retention in film and the 
repeat analysis.
    e. Fixer retention in film (Sec. 900.12(e)(3)(i))
    This test determines the quantity of residual fixer in processed 
film, which is an indicator of insufficient washing. Insufficient 
washing may have a considerable adverse effect on image quality.
    (Comment 478). One comment believed that the fixer retention test 
should be a semiannual test.
    FDA notes that quarterly performance was recommended by the ACR 
manuals and required under the interim regulations. The agency believes 
that it is generally accepted that facilities should perform this test 
quarterly and has retained the frequency requirement of this test as 
proposed.
    f. Repeat analysis (Sec. 900.12(e)(3)(ii))
    Facilities must perform this test quarterly with repeated and 
rejected films. If the repeat or reject rate, calculated as a 
percentage of the total films included in the analysis, changes by more 
than 2 percentage points from the rate determined the previous quarter, 
the cause of the change must be identified. (For example, if the repeat 
rate the previous quarter was 4 percent and this quarter it is 7 
percent, the cause of the change must be identified. If the repeat rate 
this quarter is 6 percent, no further action is needed.)
    (Comment 479). A few comments suggested changing ``repeat'' to 
``reject.'' One comment stated that it might be more appropriate to 
simply refer to repeat rate change, rather than repeat or reject rate 
change.
    FDA believes that while the repeat rate is perhaps the better 
indicator of unnecessary radiation exposure in the facility, the reject 
rate gives a better picture of the image quality situation. Both rates 
give useful information and should be calculated.
    (Comment 480). Some comments recommended that FDA define repeat and 
reject to ensure that all but nonclinical films are analyzed. Several 
comments requested FDA to clarify that films repeated to correct 
positioning should be included in the repeat analysis. FDA believes 
that it is current practice that all repeated films are included in the 
repeat analysis, regardless of the cause of such repeats, and so a 
regulation mandating this practice is not needed.
    Other comments expressed opinions on the most desirable frequency 
of the repeat analysis. One comment suggested that all repeats be 
evaluated and corrective action be taken when possible. Several 
comments recommended monthly repeat analysis and stated that this test 
would be less useful if it were done quarterly. Another comment urged 
monthly repeat analysis with 400 films. Another stated that the current 
method of repeat analysis every 3 months was sufficient.
    FDA believes that low volume facilities would not have sufficient 
numbers to conduct a meaningful analysis if the required frequency is 
increased. Similarly, if the minimum number of films is set too high, 
the time period required to collect them in a low volume facility will 
be so great that problems could go undetected for a significant period 
of time. FDA, therefore, has left the required frequency as quarterly 
and has not specified a minimum number of films to be included in the 
analysis. The agency notes that nothing in the regulations would 
preclude a high volume facility from performing the analysis at an 
increased frequency and with as many films as it wished.
    (Comment 481). Several comments urged FDA to include an acceptable 
limit of repeat rate in the regulations, some suggesting that it be 2 
to 5 percent. Two comments wanted FDA to require corrective action to 
lower the observed repeat rate.
    FDA again notes that, while most of these comments referred to 
``repeat'' analysis, an analysis of both the repeated and the rejected 
films is required. In response to these comments, FDA observes that it 
has long been recognized that the parameter with the greatest impact on 
the repeat or reject rate is the subjective opinion of the physicians 
doing the interpreting as to what is acceptable. As noted in the 
preamble to the proposal (see 61 FR 14860), the repeat or reject rate 
could be reduced by a facility through acceptance of lower quality 
films. Any range or maximum value for repeat or reject rate that was 
established as acceptable through a regulation thus could quickly be 
rendered meaningless as an indicator of acceptable facility performance 
by such action. Consequently, the agency believes that, while it is 
important to keep the repeat or reject rate low, it is more important 
and useful to assess the cause of any change (increase or decrease) in 
the repeat or reject rate from the previously determined value. 
Therefore, the agency has retained the proposed requirement that the 
cause of a variance of more than 2 percent from the value previously 
determined must be properly assessed and recorded.
    In looking for the cause of the change, the agency strongly advises 
facilities to assess all the factors that can affect repeat or reject 
rate. These can include personnel ability and preferences, changes in 
personnel, or variance in machines, processors, films, or chemistry 
performance.
    (Comment 482). Some comments asked why a decrease of 2 percent 
requires action.
    FDA notes, that while it may appear that a decrease in repeat or 
reject rate is a desired goal and should not require further 
assessments of the results, this is not necessarily so. For example, if 
a facility added a mobile unit to its operations, the interpreting 
physician might feel a subtle pressure to interpret films taken with 
that unit that he or she might normally reject because of the greater 
difficulty in scheduling repeat examinations at mobile units. This 
practice could lead to a reduction in the repeat or reject rate that 
does not necessarily indicate an improvement in quality. Therefore, the 
agency believes that the cause of either an increase or a decrease of 
more than 2 percent from the value previously calculated must be 
determined and any corrective actions should be recorded and assessed.
    (Comment 483). A few comments stated that repeat analysis for each 
technologist should be evaluated and followup studies should be 
standardized. One comment wanted

[[Page 55941]]

such analysis performed for each machine used in the facility.
    The agency supports the idea that analysis of the repeat rate for 
each technologist, radiologist, and/or machine can be valuable. 
However, many facilities with a sufficient volume for a meaningful 
analysis of their total operation would not have a sufficient volume 
for meaningful analysis of each technologist, interpreting physician, 
or machine. For this reason, FDA does not believe that a separate 
analysis for each technologist, interpreting physician, and machine 
should be a regulatory requirement. However, the agency recommends that 
each facility consider whether such analysis would be useful in its 
particular situation.
    (Comment 484). One comment urged FDA to provide more guidance, 
either in a guidance document or by reference to the ACR QC Manuals, as 
to criteria for repeat and reject rate evaluation and corrective 
action. Another comment stated that this section needs to be elaborated 
to specify the frequency at which this test needs to be performed both 
for large and small volume facilities, guidelines about whether the 
analysis should be site- or technologist-specific, and acceptable 
repeat or reject rates. FDA notes that it has provided guidance for 
establishing an effective repeat and reject analysis program in the 
past and may provide additional information in the future. However, the 
agency believes that, as repeat or retake analysis has been an 
established procedure in radiology for 20 years or more, abundant 
guidance is also available from other sources. As stated previously, 
the agency in the final regulation will not reference any manual in 
order to provide the QC technologists and the medical physicists with 
flexibility to design their own analysis, recording, and corrective 
action procedures.
    g. Semi-annual QC tests (Sec. 900.12(e)(4))
    The proposal included requirements for semiannual tests of darkroom 
fog, screen-film contact, and compression.
    The test of darkroom fog in Sec. 900.12(e)(4)(i) is intended to be 
performed to identify light sources in the darkroom that can cause 
significant mammographic film fogging.
    (Comment 485). One comment supported Sec. 900.12(e)(4)(i) as 
written. The comment further stated that retaining the paragraph as 
proposed would eliminate variables for inspectors when performing this 
test. Several comments urged that certain test conditions be required, 
such as: ``Carry out the test under clinical conditions, with or 
without the safelight;'' ``use previously sensitized film;'' or ``place 
the test film on the counter top or on the processor feed tray (if not 
covered), whichever is closer to a safe light that remains on when the 
film enters the processor.'' Several other comments recommended adding 
words such as ``emulsion side up'' or ``where the mammography film is 
usually handled'' at specified points in the requirement.
    After discussions with NMQAAC, FDA concluded that the comments did 
not provide a basis for amending the provision. The agency has retained 
Sec. 900.12(e)(4)(i) as proposed, except that the words ``emulsion side 
up'' have been added for clarification. The agency will provide 
information on test procedures, as some comments requested, separately. 
Each facility can design its own procedures to meet the generally 
accepted features of an adequate darkroom fog test.
    (Comment 486). A number of comments suggested requiring the 
darkroom fog test after any change in the darkroom that could result in 
an increase in the amount of fog.
    FDA agrees that many changes in the darkroom could produce darkroom 
fog but it also believes that it is difficult to specify which changes 
will lead to increased film fogging. The agency has left it to the 
judgment of the facility as to which changes may lead to increased film 
fogging and thus warrant an additional darkroom fog test.
    (Comment 487). One comment recommended that the acceptable value of 
darkroom fog be raised to 0.10 OD and believed that 60 percent of 
facilities will not be able to pass the test as written.
    FDA does not agree that the majority of facilities will not be able 
to meet the required acceptable level of dark room fogging within 0.05 
OD. This requirement is currently in effect under the interim 
regulations and the agency's inspection data indicate that most 
facilities are in compliance with this requirement.
    (Comment 488). One comment urged FDA to require a clearly written 
procedure that ensures that the darkroom tests are performed using 
mammography films.
    The agency considers this a good practice and recommends that 
facilities adopt such procedures. However, FDA does not believe that 
this requires a regulation.
    The screen-film contact test in Sec. 900.12(e)(4)(ii) is intended 
to ensure that proper contact is maintained between the screen and film 
in each cassette used in the facility for mammography.
    (Comment 489). Several comments noted that the material of the 40 
mesh screen used for the test was not specified and suggested that it 
be copper or a material with an atomic number similar to copper.
    FDA agrees with these comments and has specified the requirement of 
40 mesh copper screen in the final regulation. It has also clarified 
that all cassettes used in the facility for mammography must be tested.
    (Comment 490). Two comments asserted that a minimum background 
density needs to be specified for the screen-film contact test, with 
one of these stating that it should be 0.60 to 0.85 so that the films 
are not underexposed leading to false readings. One comment wanted 
acceptance levels to be prescribed in some detail, while another 
comment stated that additional information was needed as to what 
constitutes an adequate screen-film contact test result. Two comments 
suggested the following criterion: ``Areas greater than 1 cm are not 
acceptable, five or more areas less than 1 cm are acceptable.''
    FDA considers this test very important. A 40 mesh copper screen 
provides adequate resolution and contrast with a mammography film when 
exposed to a proper density. However, evaluations of these test results 
can be subjective and cannot be verified against a quantified 
acceptance level. Therefore, the agency cannot prescribe a numerical 
value of acceptance level in the regulation, as some comments 
suggested, because it would not be readily enforceable. FDA notes, 
however, that it does not agree with the comment that stated that five 
or more areas of poor contact with a size smaller than 1 cm are 
acceptable. The agency intends to provide further information on this 
test. The agency also notes that advice is also available in most QC 
manuals.
    Compression testing is required to ensure that a mammographic 
system provides adequate compression and, at the same time that the 
equipment does not allow dangerous levels of compression to be applied. 
In the proposal, FDA required the compression device to meet 
specifications described in Sec. 900.12(b)(12)(i) and, in accordance 
with Sec. 900.12(e)(4)(iii), to be tested semi-annually to see if the 
specifications continue to be met. After further consideration, the 
agency determined that in the final rule it would be more appropriate 
to treat the compression forces as performance outcomes rather than 
equipment specifications. As a result, the standards for the amount of 
the compression force

[[Page 55942]]

have been transferred from Sec. 900.12(b) to Sec. 900.12(e)(4)(iii). 
The comments received on this aspect of proposed Sec. 900.12(b)(12)(i) 
are discussed at this point with the related comments received on 
Sec. 900.12(e)(4)(iii).
    (Comment 491). A number of comments stated that some of the 
characteristics of the compression system described in 
Sec. 900.12(b)(12)(i) did not need semiannual QC testing.
    FDA agrees with these comments and, in the final regulation under 
Sec. 900.12(e)(4)(iii), has required that only the compression force be 
tested.
    Under Sec. 900.12(b)(12)(i)(c) FDA proposed that, 5 years after 
publication, the compression device shall provide a maximum compression 
from the power drive between 111 newtons (25 pounds) and 200 newtons 
(45 pounds).
    (Comment 492). Several comments urged FDA to make the compression 
force requirement in the power drive mode effective immediately, not 5 
years from publication as proposed. On the other hand, one comment 
disagreed with the April 1996, recommendation of NMQAAC that the 
proposed requirements be implemented 1 year after the publication of 
the final rules. One manufacturer stated that this requirement would 
affect approximately 2,000 of their units in the field and noted that 
it would be impossible to upgrade many of these units to the full 25 
pounds. Additionally, the retrofit kit is likely to be very expensive 
and not welcomed by users who find a precompression force of 17 pounds 
adequate when accompanied with appropriate manual compression.
    Although NMQAAC did recommend making the requirement effective 1 
year after publication at its April 1996 meeting, they reversed that 
position in January 1997 after considering the possible cost of the 
action. The agency has thus retained in the final rule at 
Sec. 900.12(e)(4)(iii), the requirement of compression force in power 
drive mode 5 years from the date of publication, as proposed in 
Sec. 900.12(b)(12)(i)(c).
    FDA, however, also considers it important that all mammography 
machines used currently provide adequate compression force. Under the 
interim regulations, facilities are required to use equipment that 
provides a minimum compression of 111 newtons. The agency is continuing 
to require this minimum compression force. In case of machines where 
such force is not available in power drive mode, the facilities may use 
the manual compression to attain this minimum compression requirement. 
However, 5 years after the publication of the final rule, all machines 
must provide a maximum compression force in power drive mode of between 
111 newtons (25 pounds) and 200 newtons (45 pounds).
    h. Annual QC tests (Sec. 900.12(e)(5))
    Section 900.12(e)(5)(i) through (xi) lists a number of tests a 
facility must perform annually. Action limits for the test results are 
specified, except for the system artifacts (Sec. 900.12(e)(5)(ix)) and 
decompression (Sec. 900.12(e)(5)(xi)) tests; the nature of these do not 
allow the agency to provide any quantified acceptance level. The tests 
described in Sec. 900.12(e)(5)(i) through (ix) were proposed as QC 
tests. The tests in Sec. 900.12(e)(5)(i)(x) and (xi) have been moved 
from Sec. 900.12(b) of the proposal after FDA concluded that they are 
more performance than specification oriented and, therefore, are more 
appropriately located in Sec. 900.12(e) in the equipment quality 
assurance section of the final regulation.
    (Comment 493). One comment stated that the regulation should 
require these tests to be done by a qualified medical physicist. FDA 
notes that this requirement already appears at Sec. 900.12(e)(9), which 
requires that these tests be done as part of the facility survey and 
further requires that the survey be performed by a qualified medical 
physicist.
    Two comments questioned why the proposed requirements under 
Sec. 900.12(e)(5) established testing limits different from those used 
by the accreditation body. The comments claimed that these 
``discrepancies'' will hinder compliance. FDA believes that the authors 
of these comments are mistaken. The agency assumes that by ``testing 
limits,'' the comments are referring to action limits. FDA notes that 
the action limits of Sec. 900.12(e)(5) are the same as those in the ACR 
manuals, and thus, the same as those the facilities and the 
accreditation bodies are using under the interim regulations.
    The automatic exposure control (AEC) test in Sec. 900.12(e)(5)(i) 
measures several parameters of the AEC system.
    The first action limit specified for the AEC is that it shall be 
capable of maintaining the film optical density within  
0.30 of the mean optical density as the phantom thickness and kVp are 
varied in Sec. 900.12(e)(5)(i)(A).
    (Comment 494). Some comments wanted a definition of ``Mean Optical 
Density.''
    FDA notes that such a definition was provided in Sec. 900.2(w) of 
the proposal, now Sec. 900.2(ee) in the final regulation.
    (Comment 495). Other comments asked FDA to specify the type of 
phantom needed for this test or asked if the same phantom used for the 
image quality test is required. A related comment stated that the test 
blocks used by the physicists should be specified to be 15 x 15 mm 
homogeneous material, in order to ensure an even scatter pattern or 
distribution that would not be affected by the position of the AEC and 
inhomogeneous scatter. The comment suggested that phantoms made up of 
either acrylic or BR12 can be used. Another comment wanted the test 
details and acceptance levels to be prescribed.
    The agency requires the thickness of the phantom to be varied from 
2 to 6 cm. These thicknesses are currently required under the interim 
regulation and the facilities may use any homogeneous material of 
appropriate thicknesses that will provide a film OD of no less than 1.2 
at the center of the image. The agency has previously discussed its 
rationale for not providing detailed test procedures.
    (Comment 496). One comment requested FDA to clarify whether testing 
is required with all available thicknesses and kVp's. FDA has changed 
the wording in the final regulation to clarify that AEC tracking is 
required only for phantom thickness varied over a range of 2 to 6 cm 
and for kVp's varied appropriately for such thicknesses over the kVp 
range used clinically.
    Proposed Sec. 900.12(e)(5)(i)(C) established an alternative to 
proposed Sec. 900.12(e)(5)(i)(A) by allowing the development of a 
technique chart of kVp and density control settings to ensure that the 
film optical density requirements of Sec. 900.12(e)(5)(i)(A) would be 
met in cases where it could not be done directly by AEC.
    (Comment 497). Two comments stated that a technique chart should be 
required for all machines under all situations. Two others stated that 
the proposal created a loophole for the AEC equipment specification 
requirements proposed in Sec. 900.12(b)(15)(vii)(A). One comment asked 
if a technique chart would be acceptable in the year 2000 when all 
machines are expected to meet the  0.3 OD variance 
requirement. One comment suggested eliminating the option of using a 
technique chart.
    The agency has combined the provision permitting the use of a 
technique chart with Sec. 900.12(e)(5)(i)(A) in the final rule. After 
consideration of the comments, FDA has decided to permit the use of a 
technique chart to meet the  0.3 OD variance requirement 
only for 5 years after the publication of the final regulation. After 5 
years, the AEC equipment must meet the  0.30 OD variance 
requirement directly.
    FDA has moved a provision proposed as an equipment requirement in

[[Page 55943]]

Sec. 900.12(b)(15)(vii)(B) to the quality assurance paragraph as 
Sec. 900.12(e)(5)(i)(B). As explained earlier, the move was made 
because this provision was more appropriately located with the QC 
performance tests than with the equipment specifications. This 
provision requires, effective 5 years from the publication of this 
regulation, that the film optical density be maintained within 
 0.15 of the mean optical density at the appropriate kVp-
thickness combination. Use of the technique chart to compensate for 
inadequacies in the AEC will no longer be permitted after that date.
    (Comment 498). In response to the original proposal in 
Sec. 900.12(b)(15)(vii)(B), one comment requested that FDA clarify 
whether compensation steps using a technique chart will be allowed. The 
comment also stated that  0.15 OD criteria can not be met 
if the film manufacturers allow 0.3 OD variation from one film batch no 
another.
    As noted in the previous paragraph, FDA will permit the use of a 
technique chart to compensate for inadequacies in the AEC for 5 years 
after the publication of the final rule; after that time the technique 
chart can no longer be used as an aid in maintaining the film optical 
density within  0.15 of the mean optical density at the 
appropriate kVp-thickness combination. The agency also advises 
facilities to use films from the same batch so that film variability, 
if any, is not introduced while testing AEC performance. Because film 
variability can be eliminated as a source of bias in the AEC 
performance test, there is no justification for increasing the AEC 
actions limit to  0.30 OD because that would simply mean 
that the facility would have to contend with variability of 
 0.30 from the film and another  0.30 from the 
AEC.
    (Comment 499). Two comments stated that the proposed requirement 
was too lenient, while two others believed that it was too restrictive. 
Three comments supported the proposed requirement.
    FDA believes, after discussion with NMQAAC, that it is reasonable 
to require that the  0.15 OD limit be met by all units 5 
years after publication of the final rule. The agency believes that the 
cost to meet this requirement will be minimized by the fact that, by 
the end of this period, many of the units unable to meet the 
 0.15 OD requirement will have been replaced by facilities 
on their normal replacement schedules. The agency does not believe it 
has any basis to require a tighter limit than  0.15 OD.
    Section 900.12(e)(5)(i)(C) (proposed Sec. 900.12(e)(5)(i)(B)) 
proposed that the operating OD be no less than 1.20.
    (Comment 500). Several comments suggested deleting the word 
``operating.'' One comment requested the definition of ``Operating 
OD.''
    FDA agrees that the word operating should be deleted. This 
requirement is now moved to Sec. 900.12(e)(5)(i)(C) in the final rule.
    One comment urged FDA to require a mean optical density of at least 
1.3 OD. FDA notes that the regulation allows facilities to use a higher 
film OD if they believe that will make the test a better indicator of 
the ability to detect micro-calcifications and will aid in improving 
image quality. However, the agency does not consider it necessary at 
this time to require any higher OD. The agency also notes that NMQAAC 
advised FDA to retain the 1.2 OD requirement as proposed.
    The annual test in Sec. 900.12(e)(5)(ii) tracks the kilovoltage 
accuracy and reproducibility.
    (Comment 501). A large number of comments stated that kVp accuracy 
should be within 5 percent instead of the proposed  10 
percent.
    The agency is persuaded by these comments and has made the change 
in the final regulation.
    (Comment 502). One comment questioned the justification of a very 
tight coefficient of variation for the kVp reproducibility.
    FDA believes that the coefficient of variation of a given set of 
kilovoltage measurements should be less than 0.02, as was proposed. 
This is the standard presently required under the interim regulations 
and most facilities are currently in compliance with it; there is no 
justification for relaxing the standard, either from the point of view 
of public health or a cost consideration.
    (Comment 503). Several public comments and a member of NMQAAC 
expressed concern that one widely used kVp testing instrument does not 
read below 23 kV, while kilovoltage settings as low as 21 or 22 kVp are 
sometime used. A few comments suggested requiring kVp testing at two 
clinical setting values. One comment stated that 
Sec. 900.12(e)(5)(ii)(B), as written, could be interpreted to mean kVp 
reproducibility should be measured from 25 to 30 kVp in 0.5 kVp 
increments. Another comment stated that it should be acceptable to test 
kVp reproducibility in just one setting within the clinical range.
    In response to these comments, FDA has revised the final regulation 
to require that the lowest kVp at which accuracy be tested is the 
lowest clinical used kVp that can be measured by a kVp test device. The 
agency, however, disagrees with the comments that recommend testing kVp 
at one or two clinical settings only. FDA considers it important to 
test kVp accuracy at least at the highest and lowest measurable 
clinically used values, and at the facility's most commonly used 
clinical kVp. The agency, however, has modified the regulation to 
require that the coefficient of variation of reproducibility be 
determined at the most commonly used kVp only.
    One comment claimed that the kVp accuracy requirement should be 
checked with all focal spots. The agency has no reason to believe this 
is necessary.
    The focal spot condition (proposed as system resolution) test in 
Sec. 900.12(e)(5)(iii) was proposed to evaluate the performance of the 
mammography unit by assessing the resolution capability of the system.
    (Comment 504-505). A few comments stated that some mammography 
machines could not meet the proposed resolution requirement even though 
the focal spot size was adequate. One comment maintained that the line 
pair resolution requirement was too restrictive. A member of NMQAAC 
stated that, in magnification mammography, the resolution requirement 
would be difficult to meet. These comments suggested that the focal 
spot size measurement be added as an alternative requirement, as is the 
current practice under the interim regulation. Two other comments also 
urged FDA to continue to permit focal spot dimension measurements as 
part of acceptance tests for mammography equipment evaluation. One 
comment supported replacing focal spot measurement with performance 
related specifications of system resolution.
    FDA considered the immediate economic impact on facilities of 
meeting the resolution requirement as proposed and decided to permit 
continued use of the focal spot size measurement as an alternative to 
the measurement of system resolution for a period of 5 years from the 
publication of the final regulation. During this period, facilities may 
evaluate the condition of the mammography unit by determining either 
the system resolution, proposed as Sec. 900.12(e)(5)(iii) (new 
Sec. 900.12(e)(iii)(5)(A)), or the focal spot dimensions as described 
in Sec. 900.12(e)(5)(iii)(B). The agency believes that by the end of 
this period, when the regulation will require the evaluation of system 
resolution only, many of the units unable to pass the system resolution 
test will have been replaced by the facility on its normal replacement 
schedule.

[[Page 55944]]

    The agency believes the benefits of assessing overall performance 
of the system through use of the system resolution test justify their 
transition. NMQAAC also advised FDA to require the system resolution 
test.
    (Comment 506). One comment suggested that FDA should only require 
that the resolution shall be sufficient so that the system can detect 
micro-calcifications of 300 m and greater sizes.
    FDA notes that available scientific data indicate that 50 
m resolution is necessary in mammography imaging for early and 
proper detection of micro-calcifications. This is equivalent to about 
10 cycles (lp)/mm resolution when the bar pattern is used. The agency 
believes that all new equipment meets this requirement as proposed. 
Under the interim regulation, this criterion is already being met by 
the facilities which chose to evaluate focal spots by assessing system 
resolution. Further, NMQAAC advised FDA to adopt such a requirement in 
the final regulation. For these reasons, the agency did not accept the 
comment.
    (Comment 507). A member of NMQAAC advised FDA that the units should 
be specified in SI units and suggested using ``ycles/mm'' in place of 
``ine pairs/mm.'' One comment stated that the height of the line-pair 
test pattern above the image receptor must be specified in association 
with the resolution limits and suggested that the height should be 4.5 
cm. Other comments requested clarification of ``parallel'' and 
``perpendicular'' to the axis in terms of the bars of a test pattern 
whose orientation was being described. Three comments urged that test 
specifications be included in the regulations.
    In response to these comments, FDA has added a new 
Sec. 900.12(e)(5)(iii)(A) to specify that the high contrast resolution 
bar patterns must be placed 4.5 cm above the breast support surface and 
be oriented parallel and perpendicular to the anode-cathode axis. FDA 
has also introduced cycles/mm as the primary unit.
    (Comment 508). One comment asked at what magnification the system 
is required to resolve 11 and 13 lp/mm. Another comment suggested that 
the tests should be performed at all magnifications used. Two comments 
urged FDA to require focal spot assessment for all focal spot sizes. 
One comment suggested that the system resolution should be tested with 
the grid in use. One comment suggested that the grid should not be in 
the imaging chain during magnification.
    FDA reiterates that 5 years from the date of publication of the 
final rule, all facilities must perform the system resolution test 
annually and must meet the requirements specified in 
Sec. 900.12(e)(5)(iii)(A)(1), both in contact mode and in all 
magnification mammography modes used in the facility. The agency 
believes that if a machine can meet the requirements using the large 
focal spot size used in contact mode, it will meet the requirements 
using the small focal spot size also. The agency also believes that the 
resolution test must be conducted under the normal operating condition, 
that is, for contact mammography the resolution assessment must be 
performed with the grid in place whereas for magnification mammography, 
the grids should be removed. The agency intends to provide more 
discussion about these procedures in educational documents.
    (Comment 509). Two comments stated that the line-pair minimum 
should be increased.
    FDA believes that the present values are generally accepted as 
representing the best cost/benefit compromise.
    (Comment 510). One comment recommended requiring a monthly phantom 
test with indicators of what should be expected in resolution 
capabilities at a given magnification to ensure adequate performance 
between physicist surveys. The comment also recommended that the system 
resolution in magnification mode be monitored to determine whether it 
diminishes with time.
    Although it encourages facilities to carry out this type of 
performance-based study, FDA does not believe there is adequate 
evidence to show that these additional tests would produce benefits 
that outweigh the costs facilities would incur in performing them. 
Therefore, at this time, the agency is not including them in the 
regulation.
    The beam quality and half-value layer (HVL) paragraph as proposed 
in Sec. 900.12(e)(5)(iv), required the HVL to meet the specifications 
provided in Sec. 900.12(b)(11). Two comments stated that the exact 
specifications should be included under Sec. 900.12(e)(5)(iv), rather 
than merely by reference. Two comments suggested that the upper HVL 
limits described in the 1994 ACR QC Manual should also be included and 
that HVL limits should be specified for other target filter 
combinations.
    In the final rule, FDA has specified HVL requirements only in 
Sec. 900.12(e)(5)(iv). The specifications for kVp's in the mammographic 
range are provided in a tabulated form. Values not shown in the table 
may be determined by linear interpolation or extrapolation. NMQAAC 
members were unable to reach a consensus on the value of having an 
upper limit of HVL or on what the upper limit should be. FDA views this 
as an indication that there is a general lack of consensus on this 
topic in the mammography community and, therefore, the agency has 
decided not to include any upper limit in the regulation.
    The breast entrance exposure and AEC reproducibility paragraph, as 
proposed in Sec. 900.12(e)(5)(v), established the action limit for the 
coefficient of variation of these two variables at 0.05.
    (Comment 511). Three comments suggested deleting the breast 
entrance exposure requirement, while another considered it to be an 
equipment standard. This last comment further stated that lack of AEC 
reproducibility will be identified by other QC tests and the phantom 
image. Another comment inquired whether it was the intent of the 
provision to require facilities to calculate exposure reproducibility 
for data points consisting of mR divided by mAs, or to separately 
measure the reproducibility of exposure and mAs.
    FDA believes that this test must be performed at least annually and 
that the coefficient of variation must be calculated for both exposure 
and mAs. If a unit does not indicate a post-exposure mAs value, then 
mAs should be obtained by a secondary method. In accordance with the 
movement towards the use of SI units discussed in connection with the 
new definition of air kerma (Sec. 900.2(d)), the agency has also 
introduced air kerma as the primary quantity to be measured in this 
test. Breast entrance exposure remains as an alternative quantity.
    The dosimetry test in Sec. 900.12(e)(5)(vi) determines the mean 
glandular dose delivered during a single cranio-caudal view using an 
FDA approved phantom simulating a standard breast. When the mean 
glandular dose exceeds 3.0 mGy, corrective action is required.
    (Comment 512). A number of comments were received on the 
specifications for the phantom to be used in performing this test. Some 
comments stated that most facilities are using phantoms simulating a 
4.5 cm breast and it would not be cost effective to change to phantoms 
simulating a 4.2 cm breast. One comment suggested that FDA should 
recognize that most technique charts are set using whole number 
thicknesses, arguing that 4.0 cm is probably the most reasonable. One 
comment stated that ACR phantoms are not tissue equivalent phantoms.

[[Page 55945]]

 Another comment stated that, to date, most dose data had been set 
using the RMI accreditation phantom. The comment questioned its actual 
tissue equivalence and further stated that dose standards should be set 
using a phantom that correlates as closely as possible to actual 
thickness.
    In the preamble to the proposal (61 FR 14912), FDA solicited 
comments about actual thickness that the existing phantoms simulate. 
FDA did not receive enough evidence in response to this question to 
convince the agency that the existing phantoms simulate a 4.0 cm 
compressed breast more closely than they simulate a 4.2 cm compressed 
breast, which is the figure currently used. The agency, therefore, 
continues to require that the dose should be determined under the 
assumption that the phantom simulates a 4.2 cm compressed breast and 
that the technique factors should be chosen accordingly. FDA did not 
propose, nor has it required in the final rules, any change in the 
phantoms currently being used. As stated earlier, the agency believes 
that accreditation bodies should establish phantom specifications and 
related performance criteria. In the future, if better tissue 
equivalent phantoms are available to simulate a different compressed 
breast thickness that can change dose calculations significantly, the 
agency will revise the thickness requirement for average dose 
calculation. FDA also notes that a change from 4.2 cm to 4.0 in 
thickness does not result in a significant change in the calculated 
dose.
    (Comment 513). One comment stated that calculation of the entrance 
dose to the phantom is not necessary if kVp, HVL, and mAs for the 
exposure are within limits. Another comment stated that, because the 
existing image quality phantom simulates a 4.2 cm compressed breast, 
not 4.5 cm, the dose limit could be lowered. One comment stated that 
the regulations should not allow any dose less than 0.8 mGy, while 
another comment stated that there is no reason for accepting 300 mrad 
as a maximum mean glandular dose because, even at 25 kVp, the typical 
mean glandular dose is 120-150 mrad (1.2-1.5 mGy). This comment 
recommended setting the dose limit at 250 mrad (2.5 mGy). Another 
comment recommended that FDA consider lowering the patient dose 
requirements to that of the State of California requirement.
    FDA strongly believes that a proper dose calculation at least once 
a year for each unit is critical for public health and safety. FDA 
further believes that the present dose limit of 3.0 mGy provides 
adequate protection from unnecessary radiation and does not want to 
change the dose limit to 2.5 mGy or establish a lower limit of 0.8 mGy, 
in order to avoid the possibility of inhibiting future advances in 
imaging technology, as discussed in the preamble to the proposal (61 FR 
14912).
    (Comment 514). One comment suggested that the phantom kVp and mAs 
must be compared to the average of 20 or more 4.2 cm clinical breast 
mammograms to ensure that the measured glandular dose is consistent 
with patient radiation doses.
    In response to this comment, the agency notes that the dose must be 
determined with technique factors and conditions used clinically for a 
standard breast. The agency understands that, for some facilities, 
commonly used technique factors may be slightly different from what 
would be technique factors for a standard size breast and therefore 
different from what would be used for the available phantom, which 
simulates a standard breast. However, the agency does not believe that 
dose will vary so significantly that it will exceed the required limit 
of 0.3 mGy in cases of patients with non standard breast size, as long 
as the mammography unit is capable of meeting the dose requirement 
using a phantom simulating a standard breast.
    (Comment 515). Two comments urged FDA to require that the time of 
exposure be less than or equal to 2.5 seconds. FDA did not accept this 
comment because the agency believes that it does not have enough 
evidence to confirm that 2.5 seconds is the absolute maximum exposure 
time needed to cover all patient sizes. The agency recommends that 
facilities determine the proper exposure time for their needs through 
consultation with the medical physicists and the equipment 
manufacturers.
    The requirements for X-ray field/light field/image receptor/
compression paddle alignment in Sec. 900.12(e)(5)(vii) are intended to 
ensure that: (1) All systems have beam limitation devices that prevent 
the patients from receiving unnecessary radiation dose, permit imaging 
of the critical breast tissue near the chest wall, and avoid white 
borders on the film; (2) if a light field is provided, the congruence 
of the light field with the X-ray field should be such that the sum of 
misalignments on opposite sides between X-ray field and light field is 
within 2 percent of the SID; and (3) the alignment of the edge of the 
compression paddle with the chest wall edge of the image receptor is 
sufficient to permit pulling the breast tissue away from the chest wall 
for imaging and to keep the shadow of the vertical edge of the paddle 
from being visible on the image. The test also ensures that the 
extension of the edge of the paddle is within 1 percent of the SID so 
that the patient's chest is not pushed away from the breast support 
surface.
    (Comment 516). One comment stated that Sec. 900.12(e)(5)(vii) 
should include exact specifications rather than just a reference to 
those specifications in Sec. 900.12(b)(5). One comment argued that 
confinement of the X-ray field within the image receptor cuts off 
useful film area and misses some of the breast tissue. The comment 
further suggested that this requirement should be changed so that the 
X-ray field can extend slightly beyond the edges of the image receptor 
in order to make full use of the film area and not potentially miss any 
breast tissue that is overlying the image receptor, and to blacken what 
would be an otherwise clear border.
    In the final regulation, FDA has moved the X-ray field/light field/
image receptor/compression paddle alignment specifications to 
Sec. 900.12(e)(5)(vii). FDA notes that Sec. 1020.31(f)(3), which the 
agency referenced in the proposal, allows extension beyond the chest 
wall edge of the image receptor by as much as 2 percent of the SID so 
as to properly image breast tissue on the chest wall side. In the final 
rule, the agency allows extension of the X-ray field beyond all edges 
of the image receptor but limits this extension to within 2 percent of 
the SID.
    (Comment 517). Two comments suggested that the term ``image 
receptor'' should be defined. In the agency's earlier discussion of the 
definitions, the agency has referenced Sec. 1020.31 as providing a 
definition of image receptor.
    (Comment 518). One comment stated that the requirement for a light 
field in this section imposes an unwarranted expense.
    FDA notes that a light field is not required but if one is present, 
it must meet the light field-X-ray field alignment requirement.
    (Comment 519). One comment urged FDA to consider relaxing the 
requirement for the alignment of the compression paddle and the breast 
support surface. One comment questioned whether limiting the extension 
of the compression paddle beyond the image receptor to within 1 percent 
of SID is achievable in all units. Another comment suggested that this 
requirement be written to more accurately reflect the need to extend 
past the edge of the image receptor, although by no more than 1 percent 
of the SID. Three comments stated that it appeared from the proposed 
regulation

[[Page 55946]]

that it was permissible for the compression paddle to be visualized on 
the mammography film.
    FDA believes that the one percent extension limitation can be 
achieved and notes that the current requirement under the interim 
regulations is one percent. The agency has also clarified the final 
rule to emphasize that the shadow of the compression paddle shall not 
be visible on the image.
    (Comment 520). One comment requested clarification on whether the 
reference was intended to be with respect to a vertical line or with 
respect to a line connecting the focal spot and edge of the image 
receptor when the requirement that the chest wall edge of the 
compression paddle not extend beyond the chest wall edge of the image 
receptor by more than one percent of SID is being met.
    (Comment 521). One comment suggested that FDA specify whether this 
requirement is with respect to the interior surface of the paddle or 
the exterior surface. The comment, however, acknowledged that this is 
not an important issue with a 1 or 2 mm paddle thickness.
    FDA disagrees with comments that suggest including all these 
details in the regulation. However, the agency wishes to clarify that 
the reference is the vertical line and the requirement refers to the 
interior surface of the paddle.
    One comment stated that this requirement should be met with all 
image receptors. FDA notes that the regulation as written requires this 
test to be performed for all full-field aperture sizes used for beam 
limitation in the facility; this will ensure that all image receptors 
meet the requirement.
    The screen speed uniformity test, as proposed in 
Sec. 900.12(e)(5)(viii), requires that at least once a year, each 
facility must ensure the consistency of the screen speed among all 
cassettes used in the facility for mammography. The same test is 
required currently at the same frequency under the interim regulation.
    (Comment 522). One comment stated that Sec. 900.12(e)(5)(viii) did 
not allow for slow and fast screen variations due to large and small 
screens having different relative speeds. Another comment suggested 
that the maximum optical density difference should be reduced to 0.15.
    FDA believes that the difference between the screen speeds of all 
cassettes, small or large, should be such that the OD variation is 
within 0.3 OD. The agency, however, does not believe that tightening 
the restriction on density difference to 0.15 is justified. Members of 
NMQAAC supported this view.
    One comment requested FDA to describe the test procedure to be 
used. As discussed earlier, FDA made a general decision to refrain from 
describing specific test procedures for QC tests in the regulations. 
The agency will include a more detailed description of some tests in 
its guidance document.
    System artifacts in Sec. 900.12(e)(5)(ix) mean artifacts produced 
by any part of the mammographic system, including the X-ray machine, 
screen-film system, and/or processors. This subparagraph requires the 
facility to determine the level and possible adverse effects of 
artifacts produced by its systems. These artifacts should be 
distinguished from the patient related artifacts.
    (Comment 523). One comment stated that the evaluation should be 
done for all full-field image receptor sizes.
    FDA agrees and has added this requirement to the final regulation.
    (Comment 524). One comment recommended elimination of this test 
because the physicists always watch for artifacts whenever a film is 
taken.
    FDA strongly believes that a separate test solely meant for 
artifact evaluation is necessary. Further, this test should also 
evaluate the whole imaging chain for the source of any artifacts 
detected.
    (Comment 525). One comment stated that the test can also be done 
with a smaller phantom positioned closer to the collimator. As advised 
by NMQAAC, FDA proposed that artifacts should be evaluated through the 
use of a test object of high grade defect-free material that is large 
enough to cover the mammography cassette.
    FDA notes the intent in requiring an object of this size is to 
capture and identify artifacts that are caused anywhere in the cassette 
and its screen-film combination. In this way, the quality of the entire 
film can be better assured. FDA understands that there may be other 
ways of accomplishing this goal, such as the method suggested in the 
comment, but the agency lacks data to confirm that the suggested 
procedure will produce equivalent results. The agency notes that the 
alternative requirement mechanism of Sec. 900.18 provides a way by 
which alternatives to the requirements can be evaluated, and possibly 
accepted, by FDA.
    (Comment 526). One comment stated that more guidance should be 
provided on evaluating artifacts. One comment wanted the test details 
and acceptance levels prescribed.
    Again, FDA has decided that test details are subjects more 
appropriately addressed separately from the regulations. The agency 
also notes that the acceptance level for artifacts is at present a 
subjective assessment and not amenable to the establishment of specific 
numerical standards.
    (Comment 527). One respondent believed that testing X-ray systems 
for artifacts does not require the use of a test object. Another 
comment stated that use of a thick (4 cm) acrylic test object will 
harden the beam to the point that it will mask grid and/or carbon fiber 
cover artifacts and may even mask grid lines.
    FDA disagrees. The agency believes that an exposure time sufficient 
to image appreciable artifacts may not be achieved if a test object is 
not used, while these artifacts would be visible during a normal 
patient exposure.
    FDA has moved the radiation output requirement from 
Sec. 900.12(b)(15) to Sec. 900.12(e)(5)(x) because it concluded that it 
was more appropriate to treat this test as an annual QC test rather 
than an equipment specification. This test is intended to determine if 
the mammographic system is capable of producing a minimum required 
output. Five years from the publication of the final rule, the 
requirement will change to require a higher output from each system.
    (Comment 528). Two members of NMQAAC opposed this requirement as an 
annual test. One member stated that a 3-second field test of the unit 
may cause damage to the tube. The same NMQAAC member further stated 
that averaging the results over a 3-second exposure time would not 
reveal whether the output rate dropped unacceptably low at any time 
during the exposure.
    FDA does not have evidence indicating that any significant 
fluctuation in exposure takes place within an exposure time of the 
order of 3 seconds. However, the agency has revised this requirement in 
Sec. 900.12(e)(5)(x)(B) from that originally proposed in 
Sec. 900.12(b)(14) to clarify that no instantaneous radiation output 
requirement is intended; instead, the requirement is the output 
averaged over a 3-second period. Also, because the exposure times can 
be lengthy for some patients, the agency does not consider 3-second 
exposure time unreasonable. The agency also considers a yearly check of 
radiation output important and reasonable.
    i. QC tests--other modalities (Sec. 900.12(e)(6))
    This provision requires facilities using image receptor modalities 
other than screen-film to establish a quality assurance program that is 
substantially the same as that recommended by the image receptor 
manufacturer, except that the maximum allowable dose is not allowed to 
exceed that established in

[[Page 55947]]

Sec. 900.12(e)(5)(vi) for screen-film systems.
    No public comments were received on this paragraph and it has been 
codified as proposed.
    j. Mobile units (Sec. 900.12(e)(7))
    This provision requires mammography units used at more than one 
location to meet all of the quality assurance requirements established 
in Sec. 900.12(e)(1) through (e)(5). In addition, at each visit at each 
examination location, before any additional examinations are conducted, 
the facility is required to verify the performance of such units using 
an adequate test method.
    (Comment 529). Three comments supported the additional testing of 
mobile units. One of these noted that the many environments in which 
the units operate made the testing necessary. Six comments opposed the 
additional testing. The most common reasons given for the opposition 
was concern about being able to process the test images before 
mammography is performed and that the additional testing was 
unnecessary because moving the unit did not create any problems.
    When the need for additional testing of mobile units was discussed 
at the NMQAAC meeting of September 1994, it was noted that a recent ACR 
survey of facilities operating mobile units had found that about one in 
seven facilities reported quality problems with their mobile units at 
least weekly. Largely based on this information, NMQAAC recommended 
that postmove, preexamination testing of mobile units be included in 
the final regulations. NMQAAC continued to support this proposed 
requirement at its January 1997 meeting.
    FDA agrees that no change should be made to the proposal. The 
agency further notes that several of the opposing comments based their 
concern upon the difficulty of processing phantom images at the mobile 
site. However, the final regulation does not require the use of any 
specific test, only that the test method be able to verify that 
adequate image quality is being produced by the unit. This gives the 
facility the option of using other tests that do not require processing 
of images before examinations are conducted, as long as the test can 
demonstrate that adequate image quality is likely to be achieved. One 
such test, based on the consistency of mAs readings, was described by a 
speaker at the September 1994 NMQAAC meeting.
    (Comment 530). Five comments expressed concern about the fact that 
acceptable testing methods were not specified in the regulations. Three 
of these comments asked who a facility should consult to determine if 
its test method would be considered adequate by FDA. Related comments 
on this issue asked how inspectors would determine adequacy without 
guidance and noted that the State of Massachusetts left it to the 
medical physicist to determine what test method should be used. One 
comment urged that a test based on the mAs reading be considered 
acceptable, while another stated the performance test required by the 
State of Illinois should be recognized by FDA.
    FDA plans to issue information describing test methods that it is 
likely to consider acceptable for verification of performance of mobile 
units after a move and before examinations are conducted. It is 
expected that at least one of these methods will not require the 
processing of images before the examinations begin. Because these 
methods will not be regulatory requirements, FDA may accept other test 
methods proposed by facilities, medical physicists, or other interested 
parties. Facilities are always free to discuss any particular method 
with FDA prior to establishing its use.
    (Comment 531). One comment opposed allowing central film processing 
for mobile services out of concern for degradation of the latent image 
during the time between exposure and development.
    This issue was discussed at some length at two NMQAAC meetings and 
the conclusion was that this degradation would not be significant 
during the typical times between exposure and development of mobile 
facility images. FDA, therefore, has not prohibited central processing.
    (Comment 532). One comment stated that if diagnostic imaging is 
done at a mobile facility, a radiologist should be present. Practice of 
medicine issues have made it difficult to define the distinction 
between screening and diagnostic mammography. Because of this 
difficulty, FDA has issued the final regulations to apply to all 
mammography, rather than addressing specific requirements to one area 
or the other.
    k. Use of test results (Sec. 900.12(e)(8)) 
    The provisions of this proposed paragraph were intended to ensure 
that the facility did not stop with the performance of the quality 
assurance tests but analyzed the results of the tests to determine if 
problems existed and took necessary actions to correct those problems. 
Ongoing anecdotal evidence and the MQSA inspection data indicate that, 
even 20 years after the introduction of the concepts of quality 
assurance, some facilities are still neglecting to take the important 
final steps in the process.
    Section 900.12(e)(8)(i), as proposed, requires facilities to 
compare the results of their quality assurance tests with action limits 
specified in Sec. 900.12(e)(1) through (e)(6) and, if their results 
fall outside the action limits, to repeat the tests immediately to 
verify that the testing process was not responsible for the result.
    (Comment 533). Thirteen comments opposed, at least in part, the 
requirement to repeat the tests immediately. Some of these comments 
urged that it be applied only to the processor QC, screen-film contact, 
and average glandular dose tests. Two comments supported exempting 
annual tests. Four of the comments stated that the decision about what 
tests should be repeated should be left to the medical physicist. 
NMQAAC recommended complete deletion of the proposed requirement that 
the tests be repeated immediately. One comment took the opposite view, 
stating that this requirement helps facilities identify trends.
    FDA notes that this requirement was originally added to ensure that 
the facility confirmed whether the problem was due to the equipment 
rather than an improperly performed test before it went to the trouble 
and expense of taking corrective actions. However, the agency has been 
persuaded that a facility that goes to unnecessary expense to correct 
an equipment problem that was actually a testing problem is likely to 
take steps on its own to avoid repetition of such a situation. In view 
of that conclusion, and the public comments, the requirement to repeat 
the test has been deleted from the final regulations.
    Section 900.12(e)(8)(ii), as proposed, stated that if the repeated 
tests continue to produce unacceptable results, the problem shall be 
identified and corrected before any further examinations are performed.
    (Comment 534). Seven comments stated that this provision, as 
proposed, was too broad and that at least in some cases it would not be 
necessary to shut down the entire facility until the problem was 
solved. Other comments gave the views of their authors as to which 
tests, if failed, indicated problems serious enough to require the 
facility to stop doing mammography until the problem was solved. The 
most frequently mentioned tests in this category were the processor QC 
tests of Sec. 900.12(e)(1) and the average glandular dose test of 
Sec. 900.12(e)(5)(vi), each of which was listed by 13 comments.

[[Page 55948]]

    (Comment 535). Seven comments included the image quality test of 
Sec. 900.12(e)(2) and six each, the screen-film contact test of 
Sec. 900.12(e)(4)(ii), the compression test of Sec. 900.12(e)(4)(iii), 
the tests for modalities that did not use screen-film of 
Sec. 900.12(e)(6), and the additional test for mobile units of 
Sec. 900.12(7) on their lists of tests important enough that their 
failure required problem detection and correction before mammography 
continued. The system resolution test of Sec. 900.12(e)(5)(iii) was 
listed in five comments. One comment each also would include the 
artifact test of Sec. 900.12(e)(5)(ix) (if there were ``serious'' 
artifacts), the kVp test of Sec. 900.12(e)(5)(ii), and tests of output 
and the phototimer (if the errors were ``large'') on the list.
    NMQAAC as a group supported the requirement that the problem must 
be corrected before mammography continues only in the cases of the 
processor QC tests, the average glandular dose test, and the screen-
film contact test. However, the medical physicists serving as committee 
members and consultants for NMQAAC, when discussing specific tests in 
their individual comments, presented somewhat different and conflicting 
views. They agreed that the processor QC and the average glandular dose 
tests were of sufficient importance that, if they were failed, the 
facility should cease doing mammography until the problem was 
corrected. They also supported adding the image quality test to that 
list. Opinions of these physicists were split on whether the screen-
film contact test, the automatic exposure control tests of 
Sec. 900.12(e)(5)(i), the breast entrance exposure and AEC 
reproducibility test of Sec. 900.12(e)(5)(v), the tests for modalities 
other than screen-film, and the additional test for mobile units should 
be considered important enough that their failure would require problem 
correction before mammography continued.
    After consideration of the comments, FDA agrees that not all test 
failures are serious enough to require the facility to cease doing 
mammography until the source of the problem is corrected. The agency 
also agrees with two additional comments that stated that, even if the 
test failure does indicate a problem that requires immediate 
correction, it may not be necessary to shut down the entire facility. 
For example, if the processor QC tests are failed, it may be possible 
to continue to perform mammography, but to delay processing the films 
until the processor problem is corrected, as long as the anticipated 
processing delay is not of such duration that image degradation becomes 
a concern. Similarly, if the facility has more than one mammography 
unit, the failure of one unit would not be a reason for stopping the 
use of another unit that did pass the tests.
    In response to these considerations, FDA has revised 
Sec. 900.12(e)(8)(ii) by dividing the tests into two groups. Those 
tests listed in Sec. 900.12(e)(8)(ii)(A) are those whose failure 
requires immediate problem evaluation and correction. However, the 
wording has been changed to state that the corrective actions must be 
taken ``before any further examinations are performed or any films are 
processed using the component of the mammography system that failed the 
test'' (emphasis added). If the failure is related to a component for 
which there is no alternative, for example, a failure of the facility's 
only mammography unit, then the facility will still have to cease doing 
mammography until the problem is corrected. However, if there is 
another unit or processor that has passed the tests, the facility will 
be able to continue producing and processing mammograms with that 
equipment while the problem with the first unit is corrected.
    Included in Sec. 900.12(e)(8)(ii)(A) are the processor QC tests 
(Sec. 900.12(e)(1)) and the average glandular dose test 
(Sec. 900.12(e)(5)(vi), both of which everyone who commented on this 
paragraph agreed were important enough that their failure required 
evaluation and correction of the problem before the piece of equipment 
was used for further mammography. FDA has also included the image 
quality test (Sec. 900.12(e)(2)) in this group, even though it was 
mentioned in fewer comments. The importance of this test is underscored 
by the fact that the primary goal of the MQSA is to ensure adequate 
quality mammography for all women. The agency has also included the 
additional test for mobile units (Sec. 900.12(e)(7)) because it is a 
test that directly evaluates image quality.
    FDA has also included the tests for nonscreen-film modalities 
(Sec. 900.12(e)(6)) on this list. This particular provision was 
intended to facilitate the introduction of new modalities because it 
ensures that facilities using the new modality will have an adequate 
quality assurance program, while at the same time not requiring 
amendment of the requirements of Sec. 900.12(e) before the new modality 
can be used. Because it is not possible to predict in advance what new 
modalities may appear and what QC tests may be required for them, FDA 
believes they must be placed in Sec. 900.12(e)(8)(ii)(A) to adequately 
protect the public. Should it prove to be the case that some or all of 
the tests that are applicable to the new modality might more 
appropriately be placed in Sec. 900.12(e)(8)(ii)(B), regulatory relief 
can be provided through the alternative requirements mechanism of 
Sec. 900.18 until Sec. 900.12(e)(8)(ii) can be amended.
    FDA has also agreed with comments urging that the screen-film 
contact test (Sec. 900.12(e)(4)(ii)) and the compression test 
(Sec. 900.12(e)(4)(iii)) be placed on the list of those tests whose 
failure should require taking a piece of equipment out of service until 
the problem is detected and corrected. The agency notes that the new 
wording referred to above means that failure of the first of these 
tests only requires taking the cassette in question out of service and, 
as one comment pointed out, the corrective action most likely will 
simply be replacement of the cassette. The compression test is included 
out of concerns raised by both anecdotal accounts and reports to FDA's 
Medical Device Reporting System of injuries resulting from excessive 
compression and the knowledge that inadequate compression can lead to 
poor quality images.
    Finally, FDA retained the darkroom fog test (Sec. 900.12(e)(4)(i)) 
on this list, even though it was not mentioned by any of the comments. 
FDA has concluded from studies, such as the Nationwide Evaluation of X-
ray Trends program of the Conference of Radiation Control Program 
Directors, that excessive darkroom fog is more pervasive and has a 
greater impact on image quality than is commonly realized. The agency 
also notes that the detection and correction of the problems 
contributing to darkroom fog is a relatively uncomplicated process and 
can be carried out relatively rapidly. Often the problem is associated 
with the safelight and simply discontinuing use of the safelight until 
it can be replaced or repaired may provide a temporary correction that 
would permit returning the darkroom to service.
    FDA has placed all other tests under Sec. 900.12(e)(8)(ii)(B). 
These are tests whose failure indicates that there are problems that 
must be corrected, but, for various reasons are not considered to 
present a health hazard serious enough to require taking a piece of 
equipment out of use until the problem is corrected. Retake analysis is 
included in this group (Sec. 900.12(e)(3)(ii)). In this case, 
mammography must be allowed to continue to determine if the corrective 
action has indeed had the desired effect on retake rate. Also in this 
group are tests such as kVp accuracy (Sec. 900.12(e)(5)(ii)) and 
alignment (Sec. 900.12(e)(5)(vii)), for which, as one of

[[Page 55949]]

the NMQAAC physicists argued, there are compensation methods that can 
be used as temporary corrective actions until the problem can be given 
a more permanent correction. Other tests included in this group, such 
as the system resolution test (Sec. 900.12(e)(5)(iii)--called the focal 
spot condition test in the final regulations) are early warning tests 
that give an indication of possible approaching problems. In the case 
of the system resolution test, FDA has accepted the argument of the 
NMQAAC physicist who believed that, unless the system resolution was so 
poor as to lead to failure also of the image quality test, some time 
could be permitted for the correction of the resolution problem. Of 
course, if the image quality test is failed, the piece of equipment 
will be taken out of service until the problem is corrected. Finally, 
this group includes the artifact test (Sec. 900.12(e)(xi)), for which 
there are no objective action limits against which to compare the test 
results.
    Although problems revealed by the tests in the second group are not 
considered serious enough to take a piece of equipment out of service 
until corrected, FDA believes that they must not be allowed to exist 
indefinitely. Therefore, Sec. 900.12(e)(8)(ii)(B) requires that when 
tests in this group are failed, the problems must be evaluated and 
corrected within 30 days.
    l. Surveys (Sec. 900.12(e)(9))
    This paragraph required that a facility survey be performed by a 
medical physicist no less often than once a year. The tests and reviews 
that, at a minimum, were to be included in the survey were specified 
along with requirements that the medical physicist provide a survey 
report to the facility within 30 days of the survey. Identification of 
those who performed the survey was to be provided in the report.
    (Comment 536). Two comments were received on Sec. 900.12(e)(9)(i), 
which specified that the surveys should be conducted annually. One 
comment indicated confusion about the requirement by stating that an 
annual FDA inspection was not needed if a certified physicist conducted 
biannual surveys. The other comment asked that the requirement be 
modified to allow the annual surveys to take place in a year plus or 
minus a reasonable period.
    FDA notes that an inspection is not a survey but rather is a check 
by an independent authority on how well the facility is meeting the 
requirements. An inspection and a survey serve different functions and 
are both required under the MQSA. Furthermore, the inspection does not 
duplicate the physicist's work. The inspection involves conducting only 
the tests that provide the most general picture of the equipment 
performance but also includes review of other aspects of the facilities 
performance such as personnel qualifications and reporting and 
recordkeeping practices, which are not considered by the physicist 
during the survey. Recognizing the unique characteristics of both the 
survey and the inspection, and the benefits of multiple oversight 
mechanisms, Congress required that each be conducted annually. 
Performance of more frequent surveys, semi-annually, e.g., does not 
eliminate the need for inspections. FDA has retained the requirement 
for an annual survey in accordance with 42 U.S.C. 263b(e)(1)(B)(iv). 
This requirement does not prohibit the facility from having a survey 
more frequently if it wishes. In response to the second comment, FDA 
notes that it has exercised its enforcement discretion under the 
interim regulations, and intends to continue to do so under the final 
regulations, to permit short periods of additional time beyond 12 
months for the facility to obtain a survey under certain circumstances. 
The agency has done so in recognition of the difficulty that facilities 
that rely on contract physicists have in scheduling surveys. However, 
this exercise of enforcement discretion in a particular year is not 
intended to set a pattern that will permit facilities to impemissibly 
lengthen the timeframes between surveys to longer than annually.
    (Comment 537). Several comments were received on the survey report 
required under Sec. 900.12(e)(9)(iii). One comment recommended that a 
standard physicist report format should be required to facilitate 
review. Another stated that there should be provision for 
identification of units if the facility has more than one unit or has 
installed a new unit in an old room. A third comment stated that the 
report should include the calibration dates of the exposure measuring 
instruments.
    FDA recognizes the advantages of a standardized report and in the 
past has encouraged the use of the report format recommended in the ACR 
quality assurance manuals. This format includes provision for 
identification of the unit being evaluated; such information has been 
and will continue to be implicitly required, because without it, the 
facility is unable to prove that a particular unit was included in the 
survey. FDA also believes that there has been a move towards 
standardization under the interim regulations because reports that 
inadequately provide the information needed during inspections have 
created extra work for facilities and physicists who must provide the 
information. This has led to improvements in later reports. However, 
while there are advantages to a standardized report, FDA also 
recognizes the need to allow flexibility in this respect to cover 
special situations and to permit the use of individual initiative in 
developing improved formats. The agency concludes, therefore, that it 
is both unnecessary and needlessly restrictive to require a specific 
report format by regulation.
    Because the calibration requirement for exposure measuring 
instruments (Sec. 900.12(e)(12)) is a new requirement, this information 
has not been checked during inspections under the interim regulations. 
Because it is now a requirement under the final regulations, FDA 
expects that, in most cases, this information will be included in the 
survey report and that there is no need for a specific regulation 
requiring it to be there. However, if the facility wishes to provide 
the information in some other format, it will have the flexibility to 
do so.
    (Comment 538). Four comments were related to the requirement of 
Sec. 900.12(e)(9)(iv) that the report be provided to the facility 
within 30 days of the survey. One comment suggested shortening the 
interval to 2 weeks. Another stated that Massachusetts had found that a 
requirement that the facility's lead interpreting physician sign the 
report within 30 days had been effective in ensuring that the findings 
of the medical physicist were implemented. A third comment proposed 
that the deficiencies noted by the medical physicist be corrected 
within 1 month. The fourth comment urged that if the report is not 
received within 30 days, the facility be required to take the equipment 
out of service. This, it was believed, would stimulate the physicist to 
be timely.
    FDA believes that a shorter time period would be unreasonable in 
situations where contract physicists might do several surveys in a 
several day trip before returning to his or her office to complete the 
reports. The agency also believes that it is common practice that 
before leaving the facility, the physicist gives a preliminary report 
to the facility staff, which would include identifying conditions that 
require prompt action. The new provisions of Sec. 900.12(e)(8), which 
require correction of certain serious test failures before the failed 
equipment is used for further examinations, will further stimulate the 
provision of

[[Page 55950]]

preliminary reports. The agency continues to believe, therefore, that 
the 30-day timeframe is reasonable. With respect to the second and 
third comments, the agency believes that the new Sec. 900.12(e)(8) 
adequately ensures that the more serious failures are corrected before 
the equipment is used again and that all identified problems are 
corrected within 30 days. A separate requirement is not needed here. 
With respect to the fourth comment, FDA believes that there is already 
sufficient incentive for the facility to make sure it receives its 
report within the 30 days without need for the drastic action 
suggested.
    (Comment 539). The last comment on this paragraph endorsed the 
requirement in Sec. 900.12(e)(v), that not only the physicist, but 
anyone who is performing part of the survey under the physicist's 
direct supervision be identified.
    FDA retained this requirement when the regulations were codified.
    m. Mammography equipment evaluations (Sec. 900.12(e)(10))
    FDA proposed this provision to resolve several somewhat conflicting 
concerns. The basic goal was to ensure that newly installed equipment 
or equipment that had undergone major changes is tested for adequate 
performance by a qualified person before the equipment is used for 
examinations. However, this goal had to be achieved within the 
statutory limitations that provide for the issuance of provisional 
certificates prior to the completion of the survey and that require 
review of QC data as part of the survey. Such data cannot be generated 
unless the unit is in clinical use (42 U.S.C. 263b(c)(2)). The agency 
was also concerned about the costs that might be incurred by a facility 
that required two visits by the physicist, one visit for the original 
equipment check and the second for the full survey. There was also 
concern about the possibility of reduced access attributable to delays 
in putting the equipment into use due to inability to arrange for a 
visit by a physicist for some period of time.
    Proposed Sec. 900.12(e)(10) was an attempt to balance these 
conflicting concerns by requiring a mammography equipment evaluation of 
units or processors that were either new or had undergone major changes 
before those units were put to use in performing examinations. The 
evaluations were to be done by a qualified person, who could be a 
physicist or could be another individual, such as an installer or 
manufacturer's representative, and any problems found were to be 
corrected before the equipment was used clinically.
    (Comment 540). One comment supported this paragraph as written, but 
27 comments opposed allowing anyone but a medical physicist who met the 
requirements of Sec. 900.12(a)(3) to perform the mammography equipment 
evaluation. NMQAAC also supported requiring that the physicist perform 
this evaluation.
    In view of these comments, FDA has changed the wording to limit the 
performance of the mammography equipment evaluation to a medical 
physicist or someone under the direct supervision of a medical 
physicist. As noted above, this may mean a delay of some weeks in the 
use of the equipment at some facilities until a medical physicist can 
be scheduled for the evaluation. However, the agency has been persuaded 
by the unanimity of the public comments and the advice of NMQAAC that 
the benefits of having a medical physicist perform the evaluation 
outweighs the disadvantage of a possible delay. The agency also notes 
that by planning ahead, the facility may be able to minimize this 
delay.
    (Comment 541). Several comments addressed the issue of the content 
of the mammography equipment evaluation. Two comments urged that this 
be a complete survey but a third noted that the equipment would have to 
be in use for a period of time before the complete evaluation could be 
done. Four other comments suggested some specific tests to be included 
in the evaluation, but two more comments recommended leaving the 
decision about necessary testing to the person doing the testing.
    As noted above, the MQSA provisions relating to provisional 
certificates and the physical impossibility of checking QC data before 
the equipment is put into use preclude the possibility that the 
mammography equipment evaluation can be the full survey required by the 
statute. Although the agency agrees that it may be beneficial to do a 
variety of tests at the time of the equipment evaluation, it does not 
intend to designate particular tests in the regulations. The revised 
provision simply requires that the evaluations determine if the new or 
changed equipment meets the applicable requirements of Sec. 900.12(b) 
and (e), thereby focusing on the primary public health concern, which 
is to establish that units are not put into clinical use without proper 
testing. This more general wording, the agency believes, also 
eliminates the need to consider processors and mammography units 
separately with respect to this evaluation, as suggested by six 
comments.
    Related to the content of the mammography equipment evaluation is 
FDA's concern, mentioned earlier, about the expense to the facility if 
two physicist visits are required, one for a mammography equipment 
evaluation and another, later, for the survey. The agency's original 
efforts to reduce costs was its proposal to permit the mammography 
equipment evaluation to be performed by qualified individuals other 
than physicists. The revised final regulations eliminate this 
possibility. In a different approach to limiting costs to the facility, 
FDA plans to permit the initial survey of the new or changed equipment 
to be done in two stages. The first stage, the mammography equipment 
evaluation, will obviously require a facility visit by the physicist. 
If the facility and physicist can cooperate to produce adequate 
documents, FDA will permit the second stage, the review of the QC data 
after it is available, to be done by mail. Presumably, this will cost 
the facility less than two onsite visits to the facility by the 
physicist. The agency stresses that this two-stage process is intended 
to help contain costs associated with a facility's initial survey of 
new or changed equipment and is entirely optional and within the 
discretion of the facility and its physicist. The agency will require 
subsequent annual surveys of that equipment to be done at one time 
through an onsite visit.
    The proposal required a mammography equipment evaluation for new 
equipment and also after major components of the equipment were 
changed. FDA specifically asked for comments on what should be 
considered to be ``major components'' but received relatively few 
responses.
    (Comment 542). One comment suggested processor rollers in the case 
of the processor. For the X-ray unit, two comments suggested the X-ray 
tube and one of these went on to add the bucky, the screen-film system, 
and the photo-timing system. Two comments also suggested changes in the 
ventilation system because such changes can cause major artifact 
problems. Another comment simply suggested that repairs by service 
personnel should require testing.
    FDA found these suggestions useful and will take them into account 
in determining what constitutes a major component. With respect to the 
regulations themselves, in view of the limited number of comments, the 
agency decided to continue to keep the wording general.

[[Page 55951]]

    (Comment 543). One comment opposed the entire idea of a mammography 
equipment evaluation before the equipment was put into use, stating 
that it would only increase the cost of installation. Another comment, 
however, strongly supported the correction of all problems before any 
equipment was put into use. FDA agrees that there will be some cost 
associated with mammography equipment evaluations, but believes that 
the dangers inherit in permitting the use of untested equipment in 
patient examinations more than justifies this requirement. Therefore, 
the agency has retained the requirement in the final rules and 
clarified that the evaluation is also required for new and reassembled 
equipment, or whenever a major component is changed or repaired.
    n. Facility cleanliness (Sec. 900.12(e)(11))
    This proposed paragraph required the facility to establish and 
implement protocols for maintaining darkroom, screen, and view box 
cleanliness and to document that the protocols were followed.
    (Comment 544). Six comments stressed the importance of darkroom, 
screen, and view box cleanliness, primarily because of the likelihood 
that dirty conditions will lead to artifacts. Three comments took the 
opposite position, stating that the section should be deleted due to 
lack of evidence of a hazard. Seven comments urged FDA to go further 
and establish protocols for cleaning in the regulations. On the other 
hand, 13 identical comments questioned whether it would be possible for 
FDA to establish regulations on cleanliness.
    FDA believes that proper standards of cleanliness contribute to 
quality mammography; e.g., they do reduce undesirable effects 
associated with artifacts. However, as the agency stated in the 
preamble to the proposed regulations, there are a variety of cleaning 
protocols and a variety of circumstances affecting the cleaning needs 
of a facility. FDA continues to believe that facilities must be given 
the flexibility to establish cleaning protocols that best fit their 
needs. The presence and use of such protocols can easily be determined 
during inspections and their effectiveness, or lack thereof, will be 
demonstrated by the results of the QC tests, such as the artifact test.
    (Comment 545). Six comments stated that FDA was paying attention to 
disinfecting the equipment but not to screen cleanliness, apparently a 
reference to Sec. 900.12(e)(13), discussed below.
    FDA disagrees with these comments and believes that adequate 
attention has been paid to both areas. The agency also notes that the 
infection control requirements will also address the concerns raised by 
the comment, which stated that cleanliness requirements for bucky and 
compression paddle and examination room cleanliness should be added.
    o. Calibration of air kerma (exposure) measuring instruments 
(Sec. 900.12(e)(12))
    This paragraph, as proposed, required calibration of the 
instruments used by medical physicists in their annual surveys to 
measure exposure, at least annually. Ten years after publication of the 
regulation, additional requirements would have to be met by those doing 
the calibration.
    (Comment 546). Numerous comments urged FDA to change the required 
frequency of calibration to once every 2 years. A few comments opposed 
the requirement entirely, while others suggested calibration more 
frequently than annually. In response to these comments, FDA changed 
the required frequency to once every 2 years as a normal practice, but 
also retained the requirement for calibration after a repair of the 
instrument.
    As discussed in connection with the definitions of kerma and air 
kerma, the agency has also introduced the quantity of air kerma into 
this rule in accordance with the move towards use of SI units. Also in 
accordance with the agency cost concerns discussed earlier, the 
requirements proposed in Sec. 900.12(e)(12)(ii) to be phased-in over 10 
years have been eliminated.
    p. Infection control (Sec. 900.12(e)(13))
    This paragraph was proposed in recognition of the fact that, while 
transfer of disease caused by blood borne pathogens during mammography 
has never been reported, it is theoretically possible. Therefore, the 
agency concluded that appropriate precautions should be taken. Because 
FDA believes that this concern is not unique to mammography, it did not 
propose specific requirements for mammography equipment but stated 
instead that the facility should follow the general requirements for 
infection control related to medical devices.
    (Comment 547). Seven comments opposed this requirement. Reasons 
given included that it was redundant, unnecessary, and time-consuming; 
would create needless paperwork; and did not deal with a radiation 
control problem. Two comments, however, urged additional measures, such 
as requiring informed consent and the use of protective covers. Another 
comment warned that any material placed between the breast and the 
image receptor would cause increased dose and degradation of image 
quality.
    FDA believes that the comments do not provide convincing arguments 
for a change in the agency's position in either direction. The agency 
continues to believe that at least a theoretical concern about disease 
transmission exists and that the best way to deal with this concern is 
to address it as part of infection control procedures to be followed 
during the use of medical devices in general.
6. Quality Assurance-Mammography Medical Outcomes Audit 
(Sec. 900.12(f))
    This paragraph requires that every mammography facility establish 
and maintain a mammography medical outcomes audit program for followup 
on mammographic assessments and correlation of pathology results with 
the interpreting physician's recommendations. This program should be 
designed to ensure the reliability, validity, and accuracy of 
interpretation of mammograms.
    a. General comments on medical outcomes audit
    (Comment 548). A single comment was received on the general 
difficulty in conducting a medical outcomes audit faced by facilities 
that rely on contract interpreting physicians. Specifically, the 
comment noted that there would be a higher potential for bias in 
medical outcomes audits conducted for small facilities that employed a 
relatively greater number of interpreting physicians.
    FDA disagrees that the use of a number of contract interpreting 
radiologists will necessarily result in biases in medical outcomes 
data. Data should be calculated both for the aggregate facility data 
base of patients and again for each interpreting physician. Because the 
data are to be calculated for individual physicians, any particular set 
of data that represents unusual or anomalous results will be readily 
identified and additional calculations can be performed by the facility 
to project average outcomes without that outlying data. The benefit of 
tracking these results, therefore, includes the ability to identify 
problems and find trends. The facility will be required to designate a 
reviewing interpreting physician to review these data and to notify all 
interpreting physicians, including contract interpreting radiologists, 
of both aggregate and individual results. Such analyses may require 
followup actions, which are to be documented by the reviewing 
interpreting physician.
    b. Confidentiality
    The issue of maintaining confidentiality of medical outcomes audit 
information collected by the

[[Page 55952]]

facility during its mammography medical outcomes audit was a highly 
controversial area and generated a diverse number of comments. Five 
comments stated that FDA should collect audit results and publish the 
information in aggregate form for the public's information. Two 
additional comments argued that interpreting physician performance data 
should be made available to any third party or examinee.
    On the other hand, 25 comments urged that FDA ensure 
confidentiality of medical outcomes audit data either through Federal 
legislation or under the MQSA. Thirteen comments sought to protect the 
data by making it available only for internal purposes and restricting 
its submission to FDA and other agencies. One respondent expressed 
concerns relating to the use of data by third parties, such as 
facilities, radiologists, and patients. The comment went on to say 
that, in the instance of a law suit, all such information would be 
subpoenaed. Five comments stated that due to lack of common definitions 
and public understanding of the statistics most likely to be captured 
in the medical outcomes audit, such data should not be made available 
to any person not affiliated with the facility. Nine other comments 
agreed that medical audit data should not be shared with others outside 
the facility, even though they agreed that valuable use can be made of 
the medical audit within the facility in assessing the accuracy of 
interpretations. Two comments argued that, unless false negative cases 
are required to be included in the medical outcomes audit and also 
protected from discovery, there will be incentives to conduct poor 
quality audits. Finally, one comment stated that medical outcomes audit 
requirements inevitably will increase third-party requests for medical 
audit data in order to select providers.
    FDA recognizes the very sensitive nature of the issue of 
confidentiality of mammography medical outcomes audit data. Under the 
final regulations, there are no requirements for dissemination or 
reporting of the data to public bodies or other agencies, including 
FDA. There is, however, a requirement that each facility establish and 
maintain a system to conduct followup and make that system available 
for review by the inspector. Followup is required for all positive 
mammograms and for those patients who are known to have developed 
breast cancer after having had a mammogram at the facility. There is 
also a requirement for internal facility review of these data. FDA 
believes these regulations ensure the establishment and use of medical 
outcomes audit data to help protect the public health without 
necessarily jeopardizing the confidentiality of such data or the 
incentives facilities and practitioners have to use these data to 
improve performance. Future regulations are possible in this area.
    (Comment 549). Fifteen comments wondered if radiologists could 
refuse to allow an inspector to copy audit data in addition to visually 
reviewing it. As discussed previously, FDA does not intend to have 
inspectors obtain photocopies of medical outcomes audit information. 
The agency is requiring inspectors only to verify that systems are in 
place for the facility's use as part of a quality assurance program 
(see earlier discussion in the preamble to the proposal at 61 FR 
14875).
    c. General requirements (Sec. 900.12(f)(1))
    This paragraph requires facilities to establish and maintain a 
system for collection and review of outcome data and correlation of 
pathology results with initial mammographic results. The active 
collection and followup of data are to focus on positive mammograms 
with correlation between pathology results and interpreting physician's 
initial mammographic interpretation.
    (Comment 550). Overall the comments about this paragraph were 
generally positive. Eight comments stated that the requirement would be 
beneficial to mammography facilities and staff. A small number of 
comments advocated that followup data be collected for all abnormal 
mammograms, including those requiring additional imaging before a final 
mammographic interpretation can be made.
    FDA notes that the current language of the final regulations states 
that a system is to be in place to collect and review outcome data for 
all mammograms with required followup for positive mammograms. Although 
followup is required only for positive mammograms, facilities that wish 
to follow all their cases are encouraged to do so. Future MQSA 
regulations may include such a requirement for broader followup, 
including for those mammograms requiring additional imaging before 
determination of a final mammographic result.
    Followup for patients with abnormal mammographic results has been 
conducted successfully by several different groups, including the 
National Cancer Institute Breast Cancer Surveillance Consortium, CDC, 
individual groups of radiologists, and on a statewide basis in 
Colorado. Followup for all patients with abnormal mammographic results, 
or symptomatic for breast cancer, or requiring additional imaging 
studies was successfully accomplished in Colorado through the Colorado 
Mammography Advocacy Project (CMAP).
    As mentioned previously under the discussion on the use of the 
mammography medical outcomes audit as an alternative approach to design 
and process-based regulations, the National Cancer Institute's Breast 
Cancer Surveillance Consortium has also established a major research 
project to understand the full effect of breast cancer screening on 
cancer outcomes. Data on breast cancer screening practices from nine 
sites across the country are being linked to population-based cancer 
registries. By 2000, the database will contain information on nearly 
3.2 million mammographic examinations and over 24, 000 cases of breast 
cancer. Standardized procedures and tools were created and are being 
tested by the surveillance consortium that will assist mammography 
facilities in data collection and auditing. Results and outcomes of the 
consortium will help establish performance standards for mammography 
and FDA will evaluate these for appropriateness for future standards 
under MQSA.
    CMAP is a centralized data management system that conducted 
followup for all women with abnormal mammograms and women with symptoms 
of breast changes. CMAP also prompts return for regular rescreening 
through a series of reminder letters to women and their physicians. 
This system involves voluntary participation of mammography centers, 
with most facilities in the greater Denver metropolitan area 
participating. CMAP services were also offered to some or all patients 
outside of the metropolitan region. The same tracking and followup and 
screening reminder methods were used at these facilities as for those 
in the Denver metropolitan area. Data collection for individual 
patients, facilities, radiologists, surgeons, and referring physicians 
is governed by stringent standards for confidentiality. During the 8 
years of operation of CMAP, the Program ensured that there were no 
breaches in confidentiality protocols. Followup includes collection of 
all information about diagnostic procedures performed to evaluate 
mammographic abnormalities. Currently, CMAP is tracking more than 
200,000 women and more than 300,000 mammograms with approximately 3 
percent falling into the ``positive'' category based on radiologists' 
mammographic interpretation. The system has documented screening

[[Page 55953]]

compliance rates in excess of 85 percent and improved outcomes 
associated with the diagnosis of breast cancer. Specifically, women 
tracked by CMAP and diagnosed with breast cancer had smaller tumor 
sizes and earlier stages at detection when compared to a cohort of 
women with breast cancer who had not received the level of tracking and 
followup performed by CMAP.
    (Comment 551). Twelve respondents supported the FDA requirement for 
collection of outcomes data, but requested that FDA establish 
guidelines for the content of the audit and the audit process in order 
to ensure comparability of medical outcomes data. In contrast, three 
comments supported the current FDA position to establish only very 
general requirements for the medical outcomes audit.
    In the absence of any consensus standards for either mammography 
outcomes or data collection methods, FDA has chosen to defer proposing 
these parameters and methods until more research has been completed and 
clear guidelines can be formulated for mammography centers.
    Despite the general support for the medical outcomes audit, 28 
comments expressed concerns that there is no consensus on measures of 
mammographic efficacy. As discussed above, FDA acknowledges the lack of 
substantive research on appropriate and accurate measures to assess 
accuracy of mammographic interpretation and, therefore, has not 
required specific data to be collected for the medical outcomes audit. 
Instead, the agency has established a general requirement that 
mammography facilities have a system in place to collect and review 
outcome data for all mammograms. Followup is mandatory only for 
positive mammograms and for patients who were previously screened at a 
facility and were subsequently found by that facility to be diagnosed 
with breast cancer.
    In addition, the same 28 comments maintained that there was no 
evidence that performance feedback about mammography outcomes affected 
the quality of care. In fact, however, the agency notes that there are 
several articles in peer-reviewed journals indicating that performance 
feedback is an effective strategy to issue positive behavior change 
(Ref. 3).
    (Comment 552). Many comments expressed concern about the impact on 
audit results of serving diverse populations of patients. It was 
recommended that FDA keep such variations in mind when more clearly 
defined medical outcome standards are established in the future.
    FDA acknowledges the importance of this point and will take 
population diversity into account in the future development of more 
specific audit parameters.
    (Comment 553). Three comments stated that the medical outcomes 
audit requirement emphasized detection of false positives and expressed 
the opinion that this was a meaningless outcome. Three more stated that 
the most important measure was the rate of false negatives.
    FDA notes that the final regulations do not require reporting of 
either false negatives or false positives. The emphasis is on 
collecting followup data for all patients with positive mammographic 
findings and for patients who received mammography at a facility and 
were later determined to have breast cancer. Such followup may yield a 
number of statistics, including false negatives and false positives.
    NMQAAC has suggested that FDA provide reference articles to which 
facilities could refer if they wanted to compare their own statistics 
with those of other practices. FDA supports this type of educational 
outreach and intends to list such references in Mammography Matters as 
they become available. NMQAAC also noted that future revisions of the 
regulations may require specific performance standards to be issued for 
mammography once scientific evidence supports such performance 
standards. The agency agrees that such future developments are 
possible. However, the current regulation requires followup only for 
patients with positive mammograms as defined by the assessment 
categories of ``suspicious'' and ``highly suggestive of malignancy'' 
and for patients who received mammography at a facility and were later 
determined to have breast cancer.
    (Comment 554). Twenty-seven comments expressed concerns about 
burdens imposed by the FDA requirement for medical outcomes audit. The 
burdens included both financial costs of conducting the audit and 
concerns about staff time to collect the outcomes data. A subset of 
these comments specifically cited costs associated with the need for 
sophisticated computerized systems and an increase in clerical staff in 
order to accomplish the amount of followup required by the regulation.
    FDA notes that the number of patients requiring followup (i.e., 
those mammograms assessed as ``highly suggestive of malignancy'' or 
``suspicious'') should be relatively small compared to the general 
population of women screened at a given mammography facility. In fact, 
data from CMAP and the other programs cited above suggests that an 
average of 3.0 percent to 5.0 percent of the total population of 
patients receiving mammograms at a facility will require active 
followup. While FDA recognizes that there may be some increase in costs 
associated with staff time to conduct such followup for all positive 
mammograms and patients subsequently diagnosed with breast cancer, the 
benefits of followup are considered to outweigh the costs. In addition, 
the small number of patients requiring intense followup will not place 
an undue burden on an individual mammography facility when it is 
measured against the education and experience acquired by facility 
personnel. The information gained by staff has been shown to have a 
positive impact on interpretation skill. Feedback about patients with 
positive mammograms is extremely important information for both 
radiologists and technologists. Finally, it was the general consensus 
of the members of NMQAAC that the benefits of medical outcomes 
outweighed the costs, especially when one considers the small number of 
cases the current regulations will affect and data from centralized 
mammography tracking systems, such as the CMAP, which indicated that 
costs of followup can be minimized. One Committee member also noted 
that such followup actions could reduce costs associated with medical 
liability actions.
    (Comment 555). Sixteen comments assumed that the medical outcomes 
audit would require computerized systems and more clerical help, 
thereby resulting in increased costs.
    FDA notes that a computerized tracking system is not required by 
the final regulations. In fact, many facilities rely on a manual 
notecard tickler file to ensure appropriate and timely followup for 
eligible patients. Some facilities have joined a consortium of 
mammography centers where followup can be accomplished by a centralized 
data collection effort. Centralization of followup was designed and 
implemented very successfully for CMAP, with significant economic 
benefits and opportunities for data comparisons between one facility 
and the aggregate of all participating facilities. Utilization of 
unique identification numbers for patient, facility, referring 
physician, radiologist, and surgeon preserved confidentiality. 
Information on the type of data to collect and methods of data 
collection and interpretation will be forthcoming from FDA.

[[Page 55954]]

    (Comment 556). Three comments asserted that the responsibility for 
followup should remain with the surgeon and/or referring physician.
    FDA agrees that followup by the referring physician or surgeon may 
well be the most effective way to communicate with patients and collect 
outcome data. However, the agency's authority under the MQSA is focused 
on mammography facilities. FDA cannot establish audit or followup 
requirements for physicians who do not work as interpreting physicians 
in mammography facilities.
    (Comment 557). One comment suggested that certified facilities be 
required to share patient outcome data with other certified facilities, 
especially if that information is necessary in order to complete the 
medical outcomes audit.
    FDA has no evidence at this time that facilities are unwilling to 
share followup information with other facilities that have treated 
their patients. Upon implementation of the final regulations, FDA will 
monitor this cooperation and determine if there is a need for such a 
requirement in subsequent regulations.
    It was requested that FDA define 'correlation' of mammographic 
results with pathology results. FDA has addressed this in the comments 
on Sec. 900.2(bb) of the final regulations.
    d. Data collection (Sec. 900.12(f)(2))
    (Comment 558). This provision requires that data be collected on an 
ongoing basis for at least all patients with positive mammograms. The 
majority of the comments related to this paragraph suggested that the 
regulations require surgeons, referring physicians, and/or pathology 
laboratories to submit outcomes data to the mammography facility rather 
than requiring proactive followup by the facility for all positive 
mammograms.
    FDA agrees that such reporting would facilitate the efficient 
collection of accurate outcomes data. FDA has taken actions to 
encourage other medical entities to voluntarily provide this data 
(Journal of the American Medical Association, 1995), but as noted 
above, FDA's authority under the MQSA focuses on mammography 
facilities. FDA cannot require other entities or health care 
practitioners to collect data and forward it to mammography facilities.
    (Comment 559). One comment stated that it ``was not right to force 
a physician to file statistics with FDA just for statistics sake.''
    FDA believes that it is important to point out that the final 
regulations do not require reporting of any medical outcomes audit 
statistics to FDA. If such requirements are established in the future, 
it would only be because it was justified by public health benefits and 
not ``just for statistics sake.''
    (Comment 560). A number of comments raised concerns about the 
medical-legal implications of collecting outcomes data and some of 
these urged FDA to mandate audit protection for every facility in every 
state. Concerns were raised that the data could be subject to subpoena, 
used against facilities in malpractice claims, or evaluated by third-
party payers to award contracts. Discussion among members of NMQAAC, on 
the other hand, indicated that collection and review of data does 
result in improved breast cancer detection outcomes and can also serve 
to protect a facility in the instance of a legal claim.
    Although State laws on protection of medical audit data do vary, 
FDA believes such information is protected from use against facilities 
or physicians in the majority of cases. The Committee supported the 
regulations as they are currently written. As stated previously, the 
regulations only require that a system be in place to conduct followup 
and that such followup would be required for all positive mammograms. 
The regulations do not require disclosure of any outcomes data to FDA 
or any other entity outside the facility. The agency has concluded that 
the final regulations strike the proper balance because the benefit of 
audits in improving accuracy of interpretation outweigh concerns about 
forced disclosure to third parties.
    e. Frequency of audit analysis (Sec. 900.12(f)(3))
    This paragraph establishes guidelines for the frequency of the 
medical outcomes audit.
    (Comment 561). The majority of comments relevant to this point 
supported an annual audit of medical outcomes, but also recommended 
that the audit period end 6 to 12 months prior to the date of the audit 
in order to ensure collection of complete patient information. FDA 
recognizes the need for adequate time to elapse in order to collect all 
relevant data. In response to the comments, the provision was amended 
to clarify that the audit analysis may be completed up to 12 months 
following the close of the audit period. This additional time for 
completion of followup was supported by NMQAAC. However, because the 
requirement is to do an annual audit, a subsequent audit period will be 
in effect during the time the facility completes followup for the 
previous medical outcomes audit period.
    Comments also recommended requiring quarterly review of audit data 
by interpreting physicians. FDA established the requirement for annual 
review of these data in order to maximize the number of cases eligible 
for followup and data analysis. Facilities are free to review their 
audit data at more frequent intervals if that is useful or desirable 
for that practice. FDA notes, however, that quarterly audit review may 
not yield sufficient numbers of cases for performance of valid 
statistical analyses.
    Finally, one comment asked what was meant by individually and 
collectively' for review of medical outcomes audit data. FDA has 
revised the provision to clarify that the medical outcomes audit data 
is to be evaluated by the reviewing interpreting physician for the 
entire facility and for each individual radiologist reading mammograms 
for the facility.
    f. Reviewing interpreting physician (Sec. 900.12(f)(4))
    This paragraph requires that each mammography facility designate at 
least one interpreting physician to review medical outcomes audit data 
at least annually. This individual will also be responsible for 
analyzing results and identifying issues based on these results and 
recording any followup actions.
    (Comment 562). Eight comments expressed concerns about the utility 
and feasibility of conducting medical outcomes audit reviews for 
individual physicians. These comments reasoned that the numbers would 
be so small that findings would not be of practical or statistical 
significance, and that such analyses would also be resource intensive.
    FDA acknowledges these concerns, but expects that, over time, 
adequate data will be available for individual interpreting physicians 
that will become meaningful and will allow tests of statistical 
significance.
    (Comment 563). Five comments supported the proposal to include 
'taking corrective action and documenting such actions' in the 
requirement, while two others argued that this would not always be 
possible.
    Review of these comments and discussions with NMQAAC prompted FDA 
to change the wording to recognize that the reviewing interpreting 
physician may not always have authority to institute corrective 
actions. As revised, the proposed regulation requires the reviewing 
interpreting physician to document what, if any, followup actions were 
taken following review of the individual and aggregate medical outcomes 
audit data.

[[Page 55955]]

    (Comment 564). Nine comments noted that facility performance 
monitoring and corrective actions were not defined in the regulations 
and, therefore, this provision is unclear.
    FDA agrees and has deleted these terms in revising the language of 
this provision.
    (Comment 565). Finally, one comment recommended that the reviewing 
interpreting physician should also be the individual responsible for 
overall facility quality assurance.
    FDA does not believe that this dual role is necessary or beneficial 
for every facility, e.g., a physician who is best suited for 
responsibility over audits may not be onsite sufficiently often to also 
be responsible for overall quality assurance. Although the final rule 
would permit a facility to designate the same person for both 
responsibilities, it is not required.
7. Mammographic Procedure and Techniques for Mammography of Patients 
With Breast Implants (Sec. 900.12(g))
    This paragraph implements the MQSA provisions that require FDA to 
establish ``standards related to special techniques for mammography of 
patients with breast implants'' (42 U.S.C. 263b(f)(1)(H)).
    a. Breast implant inquiries (Sec. 900.12(g)(1))
    As proposed, this paragraph required each facility to have in place 
a procedure to inquire if an examinee has a breast implant at the time 
of mammography scheduling.
    (Comment 566). More than 110 comments opposed making this inquiry 
at the time of scheduling. Reasons for the opposition included: privacy 
concerns of the patient, the fact that the patient may not be the 
person scheduling the examination, and the belief that the best way to 
obtain this information is by having the technologist question the 
patient at the time of the examination. Eleven comments supported this 
requirement, reasoning that this would aid in efficient scheduling and 
urged FDA to publicize the need for implant patients to inform the 
facility of their situation at the time of making an appointment.
    After reviewing all comments and discussing this issue with NMQAAC, 
FDA has revised Sec. 900.12(g)(1) to require all facilities to have a 
procedure to inquire whether or not the patient has breast implants 
prior to the actual mammographic examination, but not necessarily at 
the time of scheduling. Those facilities that believe it is important 
to identify breast implant patients at the time of scheduling, in order 
for the facility to allot the correct amount of time for the study, are 
free to do so. The comments indicate that many facilities will choose 
to use the patient questionnaire to obtain this information or have the 
technologist question the patient prior to the examination.
    (Comment 567). Several comments stated that facilities should have 
the option of referring breast implant patients to facilities where 
such examinations are done regularly.
    FDA agrees with these comments and notes that there are no 
regulations requiring facilities to perform studies on patients with 
implants. For those facilities electing not to perform mammography on 
patients with breast implants, FDA strongly recommends that they 
develop a mechanism to inform referring physicians and patients of this 
fact. This will decrease the chances of such patients arriving at a 
facility that does not ordinarily perform breast implant studies.
    (Comment 568). Two comments suggested establishing a minimum volume 
for these types of examinations in order to concentrate them at 
facilities that are the best for this purpose.
    FDA recognizes that increased experience with imaging patients with 
breast implants is likely to develop expertise. However, the agency 
believes that it is in the best interest of all concerned to have high 
quality mammography performed in as many facilities as possible. It is 
possible that one technologist at a particular facility may have had 
additional training in techniques for imaging such patients and be able 
to do excellent examinations despite relatively low numbers of such 
patients. It is not the intent of the MQSA to arbitrarily restrict 
access to mammography services.
    b. Maximizing the visualization of breast tissue for patients with 
implants (Sec. 900.12(g)(2))
    This paragraph requires that patients with breast implants 
undergoing mammography have mammographic views to maximize the 
visualization of breast tissue, except where contraindicated or 
modified by a physician's directions.
    (Comment 569). Nine comments stated that it is important to take 
additional and specialized views of the implanted breast in order to 
achieve maximum visualization of tissue. The authors asserted that a 
minimum standard, such as requiring Eklund views, should be set. One 
contradictory comment stated that requiring mandatory views would cause 
unnecessary irradiation because not every implant can be displaced as 
in the Eklund procedure.
    FDA and NMQAAC agree that, currently, the Eklund procedures, 
including appropriate individualized views, provide the best 
mammographic means to visualize breast tissue for most women with 
implants. The agency and the committee also recognize that other 
methods may exist that would be preferable in particular cases. Because 
breast implant imaging is evolving, the agency believes that it would 
be premature to limit, by regulation, this imaging to only one 
technique. FDA does not believe that this regulation, as written, will 
result in unnecessary irradiation of patients because it allows 
facilities to customize the study to the individual patient.
    NMQAAC recommended deleting the phrase ``and optimize breast cancer 
detection'' as being redundant. FDA agrees and has deleted the phrase 
from the final provision.
    c. Onsite supervision of mammograms of patients with breast 
implants (Sec. 900.12(g)(3))
    FDA received almost 300 comments opposing this proposal, which 
would have required that mammograms of patients with breast implants be 
supervised by an onsite interpreting physician. Reasons for the 
opposition included: Severe scheduling and access problems if an 
interpreting physician had to be present, no demonstrated medical need 
for an onsite physician, and the belief that technologists are capable 
of performing implant examinations without the supervision of an 
interpreting physician. Four comments supported the section as 
proposed, stating that it was important to have an interpreting 
physician onsite to check the quality of the images.
    FDA has been persuaded by the comments and subsequent discussions 
with NMQAAC that requiring an onsite interpreting physician would 
result in a decrease in access to high quality mammography services for 
women with breast implants without a significant improvement in the 
quality of care. Therefore, FDA has deleted this provision.
8. Consumer Complaint Mechanism--Facility Standard (Sec. 900.12(h)) and 
Accreditation Body Standard (Sec. 900.4(g))
    These paragraphs, as proposed, establish a process for facilities 
and accreditation bodies to collect and resolve serious consumer 
complaints. It provides patients with a mechanism to report what they 
believe to be seriously deficient mammography services and gives them 
the opportunity to have their complaints heard, investigated, and 
resolved.

[[Page 55956]]

    Section 900.12(h), under facility standards, establishes 
requirements for facilities with respect to collecting and resolving 
serious consumer complaints, while Sec. 900.4(g), under accreditation 
body standards, establishes requirements for actions that accreditation 
bodies must take to resolve consumer complaints referred to them.
    Many of those who commented on the proposed regulations seemed 
unaware that different aspects of the complaint mechanism were 
addressed in these two separate paragraphs, and unaware that both 
sections should be read with reference to the definitions section of 
the regulations at Sec. 900.2. Because the comments on these separate 
provisions tended to be similar, and in order to help illustrate the 
connection between them, FDA concluded that it would be most efficient 
to address public comments on the complaint mechanism sections of the 
proposed regulations as a group.
    As the consumer representatives on NMQAAC noted, of all of the 
comments on the complaint mechanism, only two were from consumers. 
Almost all of the comments were from representatives of mammography 
facilities.
    (Comment 570). Several comments agreed with FDA that facilities 
should have the flexibility to develop their own complaint mechanism 
and institute their own procedures for response and resolution. One 
comment supported the requirement that facilities develop a system for 
collecting and resolving serious complaints about mammography services 
and the proposed definition of serious complaints. Two comments, 
including one from a breast cancer advocacy organization, expressed 
support for the consumer complaint provision that FDA proposed.
    One comment noted concern that there is no rule requiring feedback 
by facilities to FDA about an accreditation body. The comment suggested 
that FDA implement a communication mechanism for facilities to register 
complaints/comments with FDA about the accreditation body. The comment 
recommended that the mechanism guarantee followup, similar to the 
provision establishing a consumer complaint mechanism.
    FDA believes mechanisms for facility feedback to FDA already exist. 
Facilities that wish to comment about accreditation bodies may contact 
FDA's DMQRP (address above) and will receive a response. In addition, 
the statutory requirement for FDA to audit the performance of 
accreditation bodies through inspections of selected facilities 
establishes additional opportunities for review and feedback.
    (Comment 571). Two comments discussed the manner in which 
accreditation bodies might implement the complaint resolution process. 
One suggested that serious consumer complaints should be handled by an 
ACR Peer Review process. Another suggested that accreditation bodies 
could form boards to receive unresolved serious complaints.
    FDA notes that the final regulations prescribe no particular method 
for accreditation bodies to use, believing that flexibility will permit 
each accreditation body to establish a system that works best for the 
facilities it accredits and the patients they serve. Establishing 
specific groups to review unresolved complaints is one acceptable 
method for fulfilling this requirement.
    (Comment 572). One comment recommended that, because accreditation 
bodies have no enforcement authority other than to revoke or deny 
accreditation, FDA or the State certifying entity should retain 
authority to investigate consumer complaints.
    In response, FDA notes that nothing in the MQSA or the regulations 
precludes FDA or a State from investigating complaints. However, the 
agency believes consumer complaints will be addressed most effectively 
and efficiently by a three-tiered approach. First, the complaint should 
be registered at the facility, where there is the greatest chance for 
resolution. Second, serious complaints that have not been resolved at 
the facility should be directed to the accreditation body. And, third, 
the accreditation body can forward serious complaints to FDA. Although 
consumers may choose to complain to the facility, the accreditation 
body, or FDA, the intent of these mechanisms is to resolve difficulties 
quickly at the level closest to the consumer.
    (Comment 573). One comment suggested a name change for the consumer 
complaint mechanism. The author supported the proposed requirement, but 
preferred the use of either ``consumer comment mechanism,'' or 
``consumer feedback mechanism'' to encourage feedback on positive 
mammography experience(s).
    FDA and members of NMQAAC agree that the term ``complaint'' has 
negative connotations and may not encourage well-deserved positive 
comments. The statute, however, requires FDA and NMQAAC to develop a 
mechanism for the investigation of ``consumer complaints.'' 
Consequently, FDA adhered to the terminology in the statute.
    (Comment 574). FDA received seven comments requesting additional 
guidance and detail about consumer complaint procedures. Five comments 
suggested that guidance documents be made available for facilities to 
follow in generating their system for collecting and resolving 
complaints, including directions for consumers who wish to file a 
complaint with the facility's accreditation body. One comment suggested 
that FDA develop a standardized plan, with appropriate forms to review 
and evaluate each facility's consumer complaints. One comment supported 
the proposed definition of a serious complaint, but noted that most 
complaints deal with Medicare and insurance reimbursements, or lack 
thereof.
    FDA agrees that additional information will be helpful and members 
of NMQAAC have also strongly recommended that guidance be developed. 
The agency plans to develop such documents for facilities and 
consumers.
    In reference to discussions in the proposal about cultural 
considerations, one comment noted that facilities cannot reasonably be 
expected to develop complaint procedures for all possible language, 
ethnic, and literacy backgrounds. FDA agrees that to require facilities 
to make such provisions would pose an undue burden. However, the agency 
encourages facilities to design their complaint mechanism procedures to 
be responsive to the particular needs of consumers they serve.
    (Comment 575). Fourteen comments stated that the required consumer 
complaint mechanism increases costs.
    FDA believes that the requirements for the complaint mechanism are 
minimal. Preliminary estimates indicate that the costs for establishing 
and implementing a system are not significant and that many facilities 
already have such systems in place. In addition, costs of establishing 
and implementing such systems are likely to be outweighed by the 
benefits to the facility resulting from better patient relations, 
enhanced reputation, and avoidance of costs related to unresolved 
complaints that may lead to litigation.
    (Comment 576). Several comments expressed concern that some 
consumer complaints could unfairly jeopardize facilities and particular 
employees. These comments hypothesized a variety of situations: A 
facility's certification could be threatened by an examinee bent on 
vengeance (for example, if a false negative mammogram and an error in 
interpretation constitute serious complaints); certain employees could 
be singled out any time a complaint is

[[Page 55957]]

referred to a higher authority (the accreditation body); the 
technologist could be falsely accused of a myriad of issues pertaining 
to patient care. Another comment interpreted the proposed regulation to 
mean that patients with complaints must be contacted for their opinion 
on whether the facility's solutions are acceptable to them.
    FDA foresees some situations in which a facility's certification 
may be threatened as a result of consumer complaints. For example, if 
serious complaints have been continuously ignored or left unresolved by 
the accreditation body or the facility, subsequent FDA investigations 
may demonstrate that the facility is unable or unwilling to comply with 
the MQSA standards. The agency is confident, however, that most 
facilities will make a sincere and effective effort to respond to valid 
complaints and does not expect that it will be necessary to consider 
suspending or revoking certificates for this reason, except in rare 
cases. In reference to concerns about personnel being unjustly accused, 
FDA notes that technologists are not ordinarily designated as the 
individuals responsible for the facility's management and operation. To 
the extent consumer complaints lead to improvement in performance of 
individual personnel, the quality of mammography is improved at that 
facility. With respect to the need to contact consumers about 
resolution of complaints, the agency believes such communication is a 
necessary part of resolving a complaint. If consumers believe the 
facility's solutions are unacceptable, they may contact the 
accreditation body or FDA, who will try to resolve the issue on a case-
by-case basis.
    (Comment 577). Seven comments noted their objection to additional 
policies and procedures for a consumer complaint mechanism. One comment 
noted that a mandatory facility complaint mechanism is superfluous 
because effective resolution of patients' complaints is already a 
component of proper patient care. Another comment noted that each 
facility can develop its own consumer complaint plan without any 
guidelines from the MQSA. Fourteen comments suggested that FDA simply 
accept the policies and procedures for mammography consumer complaints 
that are currently in use at each facility. If no policy and procedures 
are in place, the facility should establish one.
    FDA agrees that, for the majority of facilities, effective 
resolution of patient complaints is already a component of proper 
patient care. In fact, under the interim rules, facilities are required 
to post an address where complaints can be filed with accreditation 
bodies, and maintain records of all complaints registered at the 
facilities. The requirements in the final regulations, therefore, 
should present little additional burden. Those facilities that already 
have procedures in place are unlikely to have to make any significant 
changes. Only facilities that do not have a system in place will be 
required to make any significant investment of resources. As discussed 
above, procedures are likely to benefit both the public health and the 
individual facility.
    (Comment 578). One comment suggested that the facility should have 
the option to ignore a consumer complaint. This comment stated that 
facilities should be encouraged to handle complaints, but not required 
to do so.
    Under the final regulations, a facility must establish a written 
and documented system for collecting and resolving consumer complaints. 
That system may include varying degrees of responsiveness to different 
kinds of complaints. A complaint about the temperature of the waiting 
room may be handled differently than a complaint about failure to 
receive notification of examination results. There may be certain types 
of complaints under its system that a facility decides do not merit 
additional resources beyond a verbal acknowledgment or response. 
However, the system must include a mechanism to provide consumers with 
a way to register serious complaints with the accreditation body. The 
consumer can use that information to take serious complaints to the 
accreditation body and inform the accreditation body that the facility 
made no attempt to resolve the complaint.
    (Comment 579). One comment applauded the consumer complaint 
mechanism in theory, but questioned the wisdom of permitting the 
facility to determine whether the complaint is serious. The comment 
stated that facilities should be required to record all complaints and 
provide all consumers with directions for filing complaints with the 
facility's accrediting and/or licensing body. FDA does not believe that 
the facility independently determines whether the complaint is serious 
because the definitions of ``serious complaint,'' ``serious adverse 
event,'' and ``adverse event'' (see Sec. 900.2) are the basis for such 
decisionmaking. Also, if consumers are not satisfied with the complaint 
resolution, they may complain directly to the accreditation body. A 
facility's system may require that records be kept for all complaints 
and that consumers be provided with directions for filing all 
complaints with the accreditation body if they choose to do so. 
However, tracking and providing the consumer with instructions about 
how to file a complaint with the accreditation body are required under 
the regulations only for serious complaints.
    Nine comments recommended that all complaints should be handled on 
an individual basis at each facility, and that recordkeeping should be 
based on the protocol for that facility. Two comments noted the 
additional amount of paperwork the consumer complaint mechanism would 
generate, and one of these noted the possibility that facilities would 
be open to liability because of this mechanism.
    FDA agrees that all complaints should be handled at the facility if 
possible, and that recordkeeping procedures can vary with each facility 
and each complaint, so long as tracking and accreditation body 
notification are established for serious complaints. If satisfactory 
resolution of the complaint cannot be achieved at the facility level, 
however, the consumer must have the option of taking the complaint to 
another level. In response to the concern about generation of 
paperwork, FDA notes that the requirement to track complaints has been 
in effect under the interim regulations since 1993 without any feedback 
indicating excessive paperwork. As to concerns for additional 
liability, the agency and members of NMQAAC have both noted that 
records that are required to be tracked are more likely to help 
facilities document that they responded to and resolved complaints. In 
addition, effective consumer complaint mechanisms allow facilities to 
identify problems and improve the quality of their services.
    (Comment 580). One comment advocated that some safeguard addressing 
confidentially should be implemented before this and similar 
recordkeeping requirements are retained in the final regulations. FDA 
notes that consumer complaints are part of patient records and will be 
handled by facilities with the same care as other records relative to 
patients. Accreditation bodies are required to protect nonpublic 
information they receive from facilities and will not further disclose 
such information. FDA's public information regulations prohibit 
disclosure of patient records or information that would identify 
individual patients.

[[Page 55958]]

    (Comment 581). FDA did not propose a requirement that facilities 
post a sign that explains how to file consumer complaints, although 
NMQAAC members supported such a requirement. Nevertheless, the agency 
received 28 comments, all on a form letter, opposing any requirement 
for posting of the complaint process, particularly with respect to 
addressing complaints to the accreditation body. These comments argued 
that such a notice will confuse patients and send mixed messages (e.g., 
this is a certified facility, but here's how to complain). One comment 
noted that the consumer complaint mechanism needs to be more clearly 
articulated in order to determine a mechanism for posting. The comment 
expressed concerns about promoting dissatisfaction with the screening 
experience.
    FDA notes that facilities can develop their own posting mechanism 
if they chose to do so. In these cases, the facility could use messages 
such as: ``We care about our patients. If you have comments and/or 
concerns, please direct them to (the name of the person in the facility 
who is responsible for complaints).'' FDA notes that the name of the 
accreditation body is listed on the facility certificate, which the 
facility is required by statute to post prominently within view of 
patients.
9. Clinical Image Quality (Sec. 900.12(i))
    This paragraph establishes that clinical images produced by any 
certified facility must continue to comply with the standards for 
clinical image quality established by the facility's accreditation 
body.
    This requirement did not appear as a separate provision in the 
proposal but was added to the final regulations to emphasize that 
adequate clinical image quality is to be maintained by the facility on 
an ongoing basis and is not something to be achieved only at the time 
of accreditation. FDA recognizes that this requirement may appear 
unnecessary or redundant. The stated purpose of the MQSA, to establish 
national uniform minimum quality standards for mammography facilities, 
presumes that all facilities will produce adequate mammograms on a 
regular basis. Specific statutory provisions, such as those requiring 
random clinical image review by accreditation bodies and the 
establishment of quality assurance programs at each facility to ensure 
clarity of images, reflect the drafters' intent to ensure quality 
mammograms for every patient. In addition, the interim regulations 
issued by FDA and these final regulations establish and support the 
need for maintenance of adequate clinical image quality at all times. 
However, FDA's experience with implementation of the interim 
regulations, and the impression the agency has received from some of 
the public comments, suggests that some facilities may view clinical 
image quality as important only or primarily in connection with the 
accreditation process. The agency has concluded that this critical 
standard for quality mammography should be stated explicitly in order 
to emphasize its critical importance and eliminate any chance of 
misunderstanding.
10. Additional Mammography Review and Patient Notification (Proposed 
Sec. 900.12(i) (Final Sec. 900.12(j)))
    This paragraph requires a facility to cooperate with FDA in the 
investigation of concerns about the quality of the mammography 
performed by that facility and in notification of patients or the 
public, should the investigation justify such notification. As the 
result of the addition of the new Sec. 900.12(i), Clinical image 
quality, this paragraph is now Sec. 900.12(j) in the final regulations. 
The provision has been modified from the original proposal to clarify 
that this type of review is different from those performed either for 
accreditation, reaccreditation, or for random clinical image review. 
Additional mammography review is to be used in those cases where FDA 
has reason to believe that mammography quality has been compromised and 
may present a serious risk to human health. Depending on the individual 
circumstances, this review may be an onsite evaluation or may be 
performed through the mail. Procedures for performing additional 
mammography review will be developed by the accreditation bodies and 
approved by FDA.
    If the agency determines that any activity related to the provision 
of mammography at a facility presents a serious risk to human health, 
Sec. 900.12(j)(2) requires a facility to notify patients, their 
designees, their physicians, or the public of actions that may be 
necessary to minimize the risk. Such notification may be warranted, 
e.g., in cases where diagnoses of possible malignancy may have been 
missed due to grossly inadequate performance on the part of the 
facility. Patients, their designees, health care professionals, or the 
public may have to be notified so that they may take appropriate 
remedial action. For example, affected patients may wish to repeat 
examinations at another facility or a member of the public may be able 
to contact an otherwise unreachable patient.
    (Comment 582). While seven comments supported these requirements as 
originally proposed, the authors of 26 other comments were concerned 
about possible abuse of the provisions. These comments requested more 
information and clear guidelines on how ``serious risk to human 
health'' would be determined and how the regulation would be 
implemented. One comment stated that the entire section was not needed 
and should be deleted. The authors of 25 comments stated that this 
section sounded like a consent decree without an appeals process. The 
comments also stated that the intent of this section was unclear.
    FDA notes that even comments that expressed concern generally 
supported the need to investigate and to take appropriate action at 
facilities where there is a serious risk to human health. In response 
to specific comments, the agency first notes that patient notification 
will not always be an appropriate corrective action, even in cases 
where mammography services have been inadequate. In some cases, patient 
notification could result in unnecessary patient anxiety, without 
providing the patient with any plan of action that the patient could 
take to minimize her risk. The agency recognizes the important 
consequences to the patients, the public, and the facility of pursuing 
patient notification and would not initiate such action without full 
consultation with the accreditation body and the facility and only 
following review of the additional mammography review performed by the 
accreditation body.
    Although NMQAAC agreed that the agency should exercise this 
authority with respect to facilities that are performing poorly, 
members of NMQAAC were unable to reach a consensus on guidelines for 
initiating patient notification. FDA's experience under the interim 
regulations may reassure facilities and the public that patient 
notification is not requested unless FDA has evidence, including review 
of clinical images by the facility's accreditation body, that indicates 
there is a strong likelihood that a significant number of mammograms 
taken by the facility were inadequate. In any given situation, 
notification will only be appropriate where the benefits of providing 
notice to women, who may wish to repeat the exam, outweigh any 
resultant risks, such as patient anxiety or the possible disincentive 
for future mammography screening. Because of the number of variables 
involved in any particular situation, FDA believes that the decision as 
to when a facility has sufficiently

[[Page 55959]]

serious problems to warrant patient notification is best made on a 
case-by-case basis. In the past 2\1/2\ years, two facilities have 
instituted limited patient notification after an investigation by the 
accreditation body and FDA.
    The intent of this section is to assure the public that in those 
cases of suspected compromised mammography quality, an investigation is 
performed, and depending on the results of that investigation, 
appropriate corrective action is taken. If patient notification is the 
corrective action recommended by the accreditation body and required by 
FDA, the facility will have every opportunity to participate in 
designing and implementing that notification. As with any adverse 
accreditation body or FDA action, the facility has the right to have a 
determination about patient notification reviewed and appealed within 
the agency. If the facility does not voluntarily come into compliance 
or take steps the agency has determined are necessary to ensure quality 
mammography at that facility, FDA can initiate suspension or revocation 
of the facility's certificate. In those circumstances, the facility is 
entitled to a hearing under part 16 of the agency's regulations (see 
Sec. 900.14) and hearing decisions are subject to judicial review. 
Contrary to the opinion of many respondents, therefore, FDA's 
determination that patient notification is necessary is subject to 
review and appeal.
    (Comment 583). One comment opposed this section, asserting that FDA 
already performs clinical image reviews by randomly notifying the 
facility that they have so many days to send in certain mammograms.
    FDA notes that the author of this comment mistakenly believed that 
random clinical image review and additional mammography review were the 
same. As previously stated, these two reviews are performed differently 
and address different issues and problems. Random clinical image review 
is performed as an evaluation tool by accreditation bodies in an effort 
to audit their own performance, and the performance of facilities they 
accredit. Additional mammography review is to be performed only in 
those cases where FDA believes there has been a compromise of quality 
sufficient to pose a serious risk to human health.
    (Comment 584). Two comments stated that FDA should ask the 
accreditation body to investigate questionable facilities, but that the 
type of evaluation and the final decision should be left up to the 
accreditation body.
    FDA continues to work closely with the accreditation bodies to 
coordinate all activities, especially those related to image review and 
mammography quality. Accreditation bodies are critical in establishing 
processes and parameters for additional mammography review at any 
particular facility and may be the first entity to discover information 
that indicates such a review is necessary. Nevertheless, decisions 
about whether additional mammography review or patient notification are 
necessary ultimately must rest with the agency.
    (Comment 585). One comment questioned why FDA would not start this 
process as soon as a facility fails accreditation due to clinical image 
review.
    FDA responds that accreditation clinical image review is an 
evaluation of the ``best'' images that a facility can produce and is 
scored against the accreditation body's highest standard. Failure to 
achieve the high quality standard does not necessarily mean that the 
facility's average images are of a quality likely to result in the 
misdiagnosis of significant abnormalities.
    It is FDA's view that failure of accreditation or reaccreditation 
clinical image review does not automatically indicate that the 
facility's overall quality level has been compromised to such an extent 
that there is a serious risk to human health. Unless there is other 
information indicating such a risk, the agency does not intend to apply 
Sec. 900.12(j) to this circumstance. The initiation of additional 
mammography review under this section is primarily intended to protect 
the public in circumstances where there is reason to believe an 
accredited facility is practicing in a way that may cause serious harm.

M. Revocation of Accreditation, and Revocation of Accreditation Body 
Approval (Sec. 900.13)

    This provision describes the procedures that FDA will follow in the 
event a facility's accreditation is revoked by its accreditation body 
(Sec. 900.13(a)). It also outlines the facility's responsibility if FDA 
withdraws approval of its accreditation body (Sec. 900.13(b)). No 
comments were received on Sec. 900.13(b).
    (Comment 586). One comment supported Sec. 900.13(a) as written 
while another comment stated that this section is unclear, and asked 
whether a facility is allowed to conduct mammography without 
accreditation. Another comment suggested that no FDA certification 
should continue in force after an accreditation body has revoked the 
accreditation of a facility.
    FDA issues certificates, and only FDA can determine when a 
certificate is no longer in effect. Loss of accreditation does not 
automatically mean the loss of certification. In certain unique 
circumstances, a facility may remain certified though it lacks 
accreditation. For example, a facility may be certified through a 
provisional certificate to perform mammography before it is accredited 
(42 U.S.C. 263b(c)(2)) or retain its certification for some period of 
time following FDA withdrawal of its accreditation body's approval (42 
U.S.C. 263b(e)(2)). Under the MQSA, if an accreditation body revokes 
the accreditation of a facility, the certificate remains in effect 
until such time as may be determined by FDA (42 U.S.C. 263b(e)(5)). FDA 
interprets the statute to give the agency discretion to find that the 
certificate should no longer be in effect once accreditation has been 
lost or to permit the facility to continue to perform mammography for 
some period of time following loss of accreditation. The language in 
the final regulation has been amended to reflect this discretion.
    After revocation of a facility's accreditation, FDA may conduct an 
investigation into the reasons for the revocation. Following the 
investigation, the agency may take whatever action or combination of 
actions will best protect the public health, including the 
establishment and implementation of a corrective plan that may permit 
the certificate to remain in effect while the facility seeks 
reaccreditation. (In the event that the investigation convinced the 
agency that revocation of accreditation was not justified, FDA would 
have discretion to continue the certificate in effect while the 
original accreditation body reinstated the facility or another entity 
provided accreditation). Anytime FDA determines that the revocation was 
justified and the certificate should not continue in effect, the 
facility that has lost its accreditation may no longer perform 
mammography. The final regulation has been amended to clarify that a 
facility whose certificate is no longer in effect must cease to 
practice mammography.
    (Comment 587). Three comments concerning this provision appear to 
have confused revocation of accreditation with revocation of 
certification. One suggested making the accreditation bodies 
responsible for appeals of revoked certificates, and two described 
facilities that purportedly were unable to operate for 2 years as the 
result of revocation of their certificate due to a single flawed image 
or the recommendation of the facility's accreditation body.

[[Page 55960]]

    FDA does not have enough information about the specific cases 
referenced in the last comments to respond, except to note that an 
accreditation body does not have authority to revoke a certificate. In 
response to the first comment, the agency reiterates that suspension or 
revocation of accreditation is the responsibility of the accreditation 
body, and each accreditation body is required to have internal appeals 
procedures available to all the facilities it serves. Suspension of 
revocation of an MQSA certificate, however, is the responsibility of 
FDA. Such suspensions and revocations are governed by 42 U.S.C. 263b(i) 
and the regulation implementing that section in Sec. 900.14. An 
accredited facility whose certificate FDA is seeking to suspend or 
revoke is generally entitled to a hearing before that action is taken 
in accordance with 42 U.S.C. 263b(i) and Sec. 900.14. The agency wants 
to take this opportunity to clarify, however, that a facility whose 
certificate FDA determines to be no longer in effect because its 
accreditation has been revoked is not governed by 42 U.S.C. 263b(i) or 
Sec. 900.14. In accordance with 42 U.S.C. 263b(e)(5), the certificate 
of a facility whose accreditation has been revoked remains in effect 
only until such time as determined by FDA. Although such a facility 
will be entitled to an opportunity for a timely hearing following a 
determination by FDA that the certificate is no longer in effect, it 
may not continue to practice mammography in the interim.

N. Suspension or Revocation of Certificates (Sec. 900.14)

    This section sets forth the conditions under which FDA may suspend 
or revoke a facility's certificate.
    (Comment 588). One comment supported this section as written, while 
another recommended that this section be revised to include the MQSA 
provision which authorizes States to conduct certification duties.
    As noted earlier in this preamble, the subject of States as 
certifying bodies is beyond the scope of these regulations. 
Preparations are under way to draft regulations that will govern State 
agencies that wish to become certifying bodies.
    (Comment 589). One comment recommended changing the word 
``determines'' to ``believes.''
    Suspension or revocation of a facility's certificate is an action 
against the facility that should be based on more than ``belief.'' FDA 
does not intend to take such action without making a determination that 
it is warranted.
    Because there were so few comments on this section, it has been 
codified basically as proposed. The discussion in the preamble to the 
proposal at 61 FR 14877 through 14878 describes the provisions of this 
section in detail. FDA has added failure to provide information, 
reports, or records ``to the accreditation body'' as an additional 
grounds for suspension or revocation in Sec. 900.14(a)(3). The agency 
has made this change to ensure that accreditation bodies have access to 
records, including clinical images, that are necessary for review. In 
many circumstances, the accreditation body's access to records is 
essential for it to fulfill its obligations under the statute and to 
advise FDA with respect to potential enforcement actons. A facility 
that refuses to supply such records makes it difficult, if not 
impossible, for the accreditation bodies and FDA to efficiently 
investigate or monitor mammography practices at that facility.

O. Appeals of Adverse Accreditation Decisions that Preclude 
Certification or Recertification (Sec. 900.15)

    The title of this provision has been changed to better reflect the 
fact that it describes the procedures for appealing adverse 
accreditation decisions that preclude a facility from becoming 
certified or recertified.
    (Comment 590). One comment supported this section as written, and 
another comment questioned whether a facility can submit additional 
information in its appeal to FDA, noting that ACR does not consider any 
additional information from a facility and bases its appeal findings on 
rereview of the films from the facility that were originally evaluated.
    When appealing an adverse accreditation decision, FDA will consider 
and evaluate any information provided by the appealing facility that 
may bear on the outcome of the appeal, in accordance with the governing 
regulations identified in the next paragraph.
    (Comment 591). One comment suggested adding ``or reaccredited'' in 
addition to, ``has failed to become accredited.''
    FDA agrees that the addition of ``reaccredited'' would add clarity. 
Another comment recommended that there be a timeframe for appeals. The 
MQSA establishes that the procedures in 42 CFR part 498 are to be 
followed by FDA for appeals. These regulations contain the timeframes 
to be followed for appeals under the MQSA.

P. Appeals of Denials of Certification (Sec. 900.16)

    The comments that requested clarification about the relationship 
between revoked accreditation and continued certification encouraged 
the agency to explicity address the issue of facilities that have 
received accreditation but are denied a certificate. FDA has added a 
new provision to clarify that the statute provides the agency with 
discretion to deny certification to a facility that has been 
accredited. As discussed previously in connection with the section on 
reviewing applications for certificates, FDA ordinarily will issue a 
certificate to a facility that has proof of accreditation by an 
approved accreditation body. This has been the agency's practice in the 
past and the agency intends to continue its reliance on the 
professional bodies that are expert in these reviews.
    However, there may be situations when the agency has access to 
information that was not available to the accreditation body or when 
the agency has other reasons to disagree with that body's determination 
that the facility applying for a certificate will practice quality 
mammography. In these unusual circumstances, FDA has authority to deny 
a certificate. The new provision sets forth the grounds that FDA will 
use as the bases for such denials: A finding that the facility is not 
likely to comply with the quality standards; a finding that the 
facility is not likely to permit inspections or provide access to 
records and information in a timely fashion; or a finding that the 
facility was guilty of misrepresentation in obtaining accreditation. 
These grounds are parallel to those that are the statutory bases for 
suspension or revocation of a certificate. FDA believes that it is in 
the interest of public health to ensure that such facilities are not 
permitted to begin practicing mammography rather than automatically 
granting a certificate that the agency must later seek to revoke.
    The new provision also provides appeal rights for facilities that 
are denied a certificate. These procedures are the same as those set 
forth for reconsideration and appeal of an adverse accreditation 
decision in Sec. 900.15. The procedures are mandated by the statute 
under 42 U.S.C. 263b(d)(2) and include the right to request a formal 
hearing from the Departmental Appeals Board of the Department of Health 
and Human Services.

[[Page 55961]]

Q. Alternative Requirements (Sec. 900.18)

    Section 900.18 establishes procedures for approval, extension, and 
withdrawal of alternatives to the quality standards of Sec. 900.12. 
Such alternatives can be approved if, among other things, the 
alternatives provide at least as great an assurance of quality 
mammography as the original standards. The alternative requirement 
procedure allows the agency to permit the practice of mammography to 
benefit rapidly from improvements and advancements without the need to 
first go through the often lengthy process of amending the regulations. 
When added to the interim requirements through the amendments of 
September 30, 1994 (59 FR 49808), no public comments were received. 
This section was incorporated into the final regulations with only 
minor changes. A few comments were received.
1. General Comments on Alternative Requirements
    (Comment 592). Two comments supported this section, one referring 
to it as a ``most sensible approach,'' but urged monitoring of the use 
of the alternatives after approval. A third comment suggested that 
manufacturers be required to provide documentation of approved 
alternatives to potential purchasers and that copies be available at 
the facility for review by the physicist and the inspector. A fourth 
comment urged removal of this section, stating that no variation in 
meeting the requirements should be allowed.
    FDA believes that this process is needed to avoid the danger of 
discouraging advances in mammography and freezing technology at the 
present level. If the standards had to be amended to permit use of an 
advance in methods, training, or technology, the time required for the 
amendment might well discourage members of the public from attempting 
improvements. The agency does not believe that it is necessary to make 
the third comment a regulatory requirement. Manufacturers will find it 
difficult, if not impossible, to sell equipment that does not meet the 
requirements or an approved alternative. Because facilities will demand 
such documentation and will be required to produce it to pass surveys 
or inspections, FDA concludes there will be sufficient incentive to 
provide documentation without issuance of a regulation. The agency also 
notes that copies of applications, amendments, and extensions of 
alternative standards will be available to the public in the Dockets 
Management Branch (HFA-305), Food and Drug Administration, 12420 
Parklawn Dr., rm. 1-23, Rockville, MD 20857. The Dockets Management 
Branch is open to the public between 9 a.m. and 4 p.m., Monday through 
Friday.
2. Approved Requests for Alternative Standard Notification 
(Sec. 900.18(d)(2)(ii))
    (Comment 593). One comment recommended that the justification level 
for an alternative requirement in this paragraph should be changed from 
the benefit being so great that the time required (typically more than 
1 year) for an amendment would be ``an unjustifiable risk to human 
health'' to a standard that established that the alternative 
requirement ``provides a benefit to human health.''
    FDA believes that the criterion suggested by the comment could be 
too low for some ``benefits,'' and has retained the provision as 
proposed.
3. Summaries (Sec. 900.18(d)(3))
    (Comment 594). One comment stated that the requirement for 
providing summaries of alternative standards to NMQAAC should be 
deleted because NMQAAC does not have authority to approve or reject 
actions of FDA in such matters.
    FDA agrees that NMQAAC does not have approval authority in such 
matters, but it does have the responsibility to advise FDA on matters 
related to FDA's development and implementation of standards. Because 
the agency cannot gain the benefit of this advice on alternative 
requirements without informing NMQAAC about the alternatives, FDA does 
not accept this comment.
4. Applicability (Sec. 900.18(f))
    This paragraph describes the applicability of an alternative 
requirement. The proposal limited the use of the alternative to the 
applicant, with the exception of alternative requirements approved for 
manufacturers of equipment, which would apply to all users of the 
equipment. Under the proposal, others desiring to make use of other 
alternative requirements would have to apply separately.
    (Comment 595). Four comments stated that FDA should reserve the 
authority to extend any approval beyond the applicant. A fifth comment 
went further and advocated automatic extension of an approved 
alternative requirement to all interested parties. FDA originally 
placed the limitation on the approval of alternative requirements in 
order to assure itself that the conditions that prompted the approval 
of the original application also applied for other applicants.
    In light of these comments and after further consideration, the 
agency has concluded that the limitation would impose an unnecessary 
resource burden on applicants and FDA. Such a burden is not warranted 
by the low probability that an approved alternative requirement should 
not be extended to other interested and similarly situated parties. 
However, because the program is relatively new and the circumstances 
that may trigger requests for alternatives are so varied, FDA has 
concluded that it should review the appropriateness of each possible 
extension instead of making it automatically approved as suggested in 
the fifth comment. Accordingly, Sec. 900.18(f) has been revised to 
permit expansion of the approval of the alternative requirement to 
other entities, but only after FDA has determined that this would be an 
effective means of promoting the acceptance of measures to improve the 
quality of mammography.
5. Other Changes
    FDA has also made a change in the administrative procedures 
included in Sec. 900.18, realizing that the level of delegation of 
authority to approve alternative requirements may vary with time or 
organizational changes. Thus, the specific references to approval by 
the Director of DMQRP have been replaced by general references to 
approval by FDA.

R. Conforming Amendments

    Conforming amendments were made to 21 CFR 16.1 to add Secs. 900.7 
and 900.14 to the list of provisions under which regulatory hearings 
are available.

IV. Environmental Impact

    The agency had determined under 21 CFR 25.34(c) that this action as 
proposed is of a type that does not individually or cumulatively have a 
significant effect on the human environment. Therefore, neither an 
environmental assessment nor an environmental impact statement is 
required.

V. Analysis of Impacts

    FDA has examined the impacts of the final rule under Executive 
Order 12866, under the Regulatory Flexibility Act (5 U.S.C. 601-612), 
and under the Unfunded Mandates Reform Act (Pub. L. 104-4). Executive 
Order 12866 directs agencies to assess all costs and benefits of 
available regulatory alternatives and, when regulation is necessary, to 
select regulatory approaches that maximize net benefits

[[Page 55962]]

(including potential economic, environmental, public health and safety, 
and other advantages, distributive impacts, and equity). The Regulatory 
Flexibility Act requires agencies to analyze regulatory options that 
would minimize any significant impact of a rule on small entities. The 
Unfunded Mandates Reform Act requires (in Section 202) that agencies 
prepare an assessment of anticipated costs and benefits before enacting 
any rule that may result in an expenditure in any 1 year by State, 
local, and tribal governments, in the aggregate, or by the private 
sector, of $100,000,000 (adjusted annually for inflation).
    The agency has conducted analyses of the final rule, and has 
determined that the rule is consistent with the principles set forth in 
the Executive Order and in these statutes. FDA's analysis, as 
summarized in the remainder of this section, demonstrates that the 
final rule constitutes an economically significant rule, as described 
in Executive Order 12866. The agency has further determined that the 
final rule may have a significant economic impact on a substantial 
number of small entities. This discussion, therefore, along with the 
other relevant sections of this preamble and the agency's final 
Economic Impact Analysis (available at the agency's Dockets Management 
Branch), constitute the agency's final regulatory flexibility analysis 
as required under the Regulatory Flexibility Act. Similarly, because 
this rule is expected to result in expenditures that exceed 
$100,000,000 in at least 1 year, these documents also comprise the 
agency's assessment of anticipated costs and benefits under the 
Unfunded Mandates Reform Act. The final economic impact analysis also 
includes all references.
    FDA presented a summary of its preliminary economic analysis in the 
preamble to the proposed rule (61 FR 14856). That summary discussed the 
potential costs and benefits of the proposed rule and described the 
findings of a more detailed industry analysis conducted by FDA's 
contractor, the Eastern Research Group (ERG). In response, the agency 
received numerous comments that addressed economic issues. FDA has 
examined and evaluated the reasoning and data presented in these 
comments and has incorporated many of them into its revised analysis of 
the final rule. The following discussion provides a summary of these 
impacts and presents the agency's responses to the relevant public 
comments.

A. Incremental Costs

    For its analysis of the incremental costs of the proposed 
regulation (``Cost and Benefit Analysis of Regulations Under the 
Mammography Quality Standards Act of 1992''; preliminary final; March 
14, 1996), FDA relied on agency experts and technical consultants to 
develop a broad profile of mammography facilities and to identify the 
type and cost of the additional equipment and procedures that would be 
needed to bring the affected facilities into compliance. That analysis 
found that the proposed rule would impose annualized industry costs of 
approximately $61.4 million. Upon review of the resulting public 
comments, FDA has maintained the basic methodology for these estimates, 
but updated or otherwise revised a number of the input variables.
    The full details of the cost estimates for these final regulations 
are presented in the agency's final Economic Impact Analysis, which is 
available for review at the Dockets Management Branch and at FDA's home 
page on the World Wide Web (www.fda.gov) the analysis addresses only 
those costs that would not have occurred in the absence of these final 
regulations. The estimates assume that at a minimum mammography 
facilities are already complying with the agency's current interim 
regulations and that a typical facility will comply with each 
requirement of the final regulation by selecting the least costly 
method of compliance. Current facility compliance levels for the 
industry were derived for early provisions of the final regulations 
from published data services or interviews with experts in mammography. 
The cost estimates are based on a facility cost model that analyzes the 
inputs to a mammographic examination (e.g., professional time, 
amortization of fixed equipment costs, variable costs of supplies) and 
derives the contribution of each activity to the average cost of 
conducting a mammographic screen. The required capital costs were 
developed from an industry wide inventory of existing equipment stock, 
which allowed FDA to estimate the percentage of equipment that will 
need to be modified or replaced. The compliance cost attributable to 
equipment requirements was calculated by including the value that this 
equipment will lose (based on years of remaining asset life) and the 
cost of retrofitting, if possible. The aggregate costs were modeled 
over a 10-year analysis period and allocated among the industry sectors 
based on facility screening volumes. This method allowed FDA to analyze 
the effect of compliance costs on small volume and large volume 
facilities.
    The analysis projects that yearly expenditures for compliance by 
mammography facilities will range from a high of $156.2 million during 
the second year of implementation to $9.5 million during the tenth 
year, with the variation reflecting the phased implementation dates for 
the individual requirements. On an annualized basis (over the 10-year 
period at a 7 percent discount rate), the yearly costs will equal about 
$38.2 million. Over the full 10-year period, the combined expenditures 
and lost resources for the largest cost element (replacement of 
mammography units with units meeting technical or quality assurance 
standards) will total more than $241 million and contribute 
approximately $28.5 million in average annual costs (75 percent of the 
total average annual costs). The other major annual cost components 
include medical records and reports, $4.6 million; quality assurance 
systems, $3.4 million; personnel qualifications, $1.6 million; and 
consumer complaint mechanisms, $0.1 million.

B. Incremental Benefits

    The benefits of the final regulations will result from improvements 
in mammography quality and include: (1) Additional life-years (or 
quality adjusted life-years (QALY's)) and reduced costs of cancer 
treatment gained by earlier stage identification of breast cancers, and 
(2) less anxiety and stress and reduced cost of followup diagnostic 
mammographic screens and other diagnostic procedures gained by fewer 
false abnormal screens. While data limitations preclude FDA from 
developing a precise estimate of the magnitude of these benefits, the 
agency has constructed an impact model that projects the expected 
health and cost outcomes under various scenarios of plausible 
mammography quality levels. This model, which forecasts breast cancer 
outcomes based on tumor stages at time of initial identification, is 
summarized below and fully described in the agency's aforementioned 
final Economic Impact Analysis.
1. Baseline Estimates
    The patient population affected by the regulation includes all 79.3 
million women age 30 or older. Applying age-specific cancer incidence 
rates to the number of women in each 10-year age cohort projects 
approximately 180,600 new breast cancer cases annually, of which about 
one-quarter may ultimately prove fatal.

[[Page 55963]]

    About 90 percent of the 25 million mammography procedures performed 
each year are for screening procedures in asymptomatic patients. Thus, 
FDA's impact model assumes a base of 22.5 million annual screens and 
2.5 million annual diagnostic (or subsequent) mammograms in symptomatic 
patients. Of the 22.5 million screens, approximately 5 million (22 
percent) are for women over the age of 65 and 2.7 million (12 percent) 
are for women younger than 40. The remaining 14.8 million annual 
screens are distributed by size of each 10-year age category. The age-
specific cancer incidence rates within each age cohort indicate that 
about 56,900 of the 22,500,000 annual screens are for women with breast 
cancer and 22,443,100 are for women without breast cancer.
    Although the benefits of the rule derive from increases in the 
quality of mammography, the quality dimensions are very difficult to 
measure. Each mammogram is unique because each patient is unique and 
many factors contribute to quality, including those that are not 
affected by these regulations. While other measures have been suggested 
(e.g., cancer yield and PPV), FDA's impact model relies on a 
combination of sensitivity and specificity levels to represent average 
mammography quality. The sensitivity of any diagnostic test is the 
proportion of the tested, diseased population that is correctly 
identified as diseased. Thus, test sensitivity addresses the problem of 
false negatives. The specificity of a test measures the proportion of 
nondiseased patients who are correctly identified as not having the 
disease. Thus, test specificity addresses the problem of false 
positives.
    If both sensitivity and specificity improve toward 100 percent, the 
proportion of ``incorrect'' mammograms decreases. Although improvements 
in one measure may come at the expense of decreases in the other, as 
certain technical changes can tradeoff sensitivity for specificity, FDA 
finds that the input changes required by this regulation will raise the 
national average of both measures. Thus, the agency's impact model 
measures quality improvement as the percent decrease (expressed as a 
percentage over the current level) in the number of incorrect 
diagnoses, both false positives and false negatives.
    Estimates of the current national average levels of mammography 
sensitivity and specificity are approximate representations, because 
they reflect literature examinations based on different patient 
populations, time periods, and definitions. Current sensitivity 
measures in community settings have ranged from 53 percent to as high 
as 90 percent and specificity measures have reached as high as 99 
percent. However, several studies indicate that mammography facilities 
in research/academic settings have sensitivity and specificity measures 
that exceed most ``typical, community facilities'' by 7 to 13 percent. 
Based on these studies, FDA's baseline estimates assume that current 
national levels of sensitivity and specificity average 80 percent and 
90 percent, respectively. The calculations use age-specific rates, 
because breast tissue density varies by age of patient.
    The estimated 80 percent sensitivity rate implies that while 45,400 
of the estimated 56,900 annually screened women with breast cancer 
currently receive a true positive result, 11,500 receive a false 
negative result. Thus, FDA estimates that each year, mammography fails 
to identify breast cancers in an estimated 11,500 screened women. The 
agency's impact model, which relies on a distribution of identified 
cancers by development stage and SEER incidence rates for both screened 
and nonscreened populations, predicts that about 4,300 of these 11,500 
women will die of breast cancer within 20 years. The model implies that 
perfect mammography would prevent about 1,200 of these fatalities. FDA 
recognizes that perfect mammographic screening is not yet 
technologically achievable, but the agency is convinced that 
mammography sensitivity rates can be significantly improved, thereby 
avoiding a substantial number of these premature deaths.
    Economic literature includes many attempts to place a dollar value 
on mortality avoidance for the purpose of conducting cost/benefit 
analysis. A common methodology estimates society's willingness to pay 
to avoid the risk of a statistical death as evidenced by wage premiums 
necessary to attract employees to riskier occupations. These data 
contain considerable variability, but appear to average about $5 
million per death avoided. Thus, for illustrative purposes, FDA's 
analysis assumes a $5 million value to represent the societal benefit 
of preventing a premature death. The value of a life-year was estimated 
at $368,000 and the value of a quality-adjusted life-year at $373,000.
    FDA also believes that the improved mammography quality gained by 
the final regulations will significantly reduce the rate of false 
positive results. The above methodology indicates that 22,443,100 women 
without breast cancer are screened annually. Consequently, a baseline 
specificity measure of 90 percent implies that 20,184,600 will receive 
true negative results, but 2,258,500 others will receive false positive 
results. FDA estimated the cost of the anxiety and increased stress 
associated with these false positive screening results by assessing the 
contribution of psychological well-being to the overall quality of 
life.
    The time between a patient notification of a positive screen result 
and the subsequent identification through a followup diagnostic 
mammogram was assumed to take about 1 month. The cost of enduring this 
anxiety was assumed to detract from the value of a quality-adjusted 
month value of $31,100, i.e., $373,000 ' 12. Research 
indicates that mental focus and psychological well-being affected by a 
major life crisis can contribute approximately 8 percent to the overall 
quality of life. Worries about health, illness, and well-being may 
account for approximately one-sixth of the stress that would constitute 
a major life crisis. To assess the potential effect, FDA's impact model 
assumes that 25 percent of those patients who receive false positive 
results would be willing to pay about $415 ($31,100 x .08 x .167) to 
avoid the stress and anxiety of a false positive mammogram.
    FDA also found that cancer treatment costs vary by stage of 
detection, from annual costs of $18,900 for the earliest stage to 
$50,000 for the latest stage. Other components of FDA's model address 
patient noncompliance with screening results due to fear or denial. 
Diagnostic mammography readings were assumed to follow positive initial 
screens, and additional followup diagnostic procedures were assumed to 
follow positive diagnostic results and to identify lesions that were 
present without screening. Based on limited data, FDA's model assumes 
that a small number of those patients with positive screens do not seek 
further treatment. Figure 1 illustrates the model components and 
baseline estimates.

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[[Page 55964]]

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[[Page 55965]]

2. Regulatory Impacts
    The agency also finds that the impact of these regulations could 
affect the demand for mammography. One study found a price elasticity 
of approximately -0.2 for outpatient well care. As the rules will 
likely raise mammography prices as well as costs, FDA incorporated this 
price elasticity into its impact model. On the other hand, improved 
mammography quality will have a positive effect on mammography demand. 
Assuming that the demand for mammography for a subset of potential 
patients exhibits a unitary elasticity with respect to quality, FDA's 
impact model finds that a 5 percent increase in mammography quality 
would roughly offset the above price-induced decline in demand, with 
the net change less than .03 percent.
    Because of the difficulty in assessing the impact of the 
regulations on mammography quality, no public comments attempted to 
quantify the likely health outcomes. Similarly, FDA cannot predict the 
precise magnitude of the quality improvement that will be generated by 
these final regulations. FDA believes, however, that the mammography 
quality improvements will be substantial and that gains as small as 5 
percent (i.e., reducing the proportion of incorrect procedures by 5 
percent by increasing average sensitivity levels from 80 percent to 81 
percent, and specificity levels from 90 to 90.5 percent) would produce 
substantial net benefits. The results of this analysis are shown in 
figure 2. For example, when compared to the baseline data (figure 1), 
the number of earlier cancers detected due to a 5 percent improvement 
in mammography sensitivity would prevent about 75 women per year from 
dying of breast cancer within a 20-year period. At $5 million per life 
saved, the discounted value of this outcome is about $234 million per 
year. Alternatively, the model shows that a 5 percent quality 
improvement would bring an annual increase of about 410 discounted 
QALY's valued at $153 million. Thus, FDA estimates the benefit of 
avoiding these premature mortalities as ranging from $153 to $233 
million per year.

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[[Page 55966]]

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BILLING CODE 4160-01-C

[[Page 55967]]

    A 5 percent quality improvement would also decrease cancer 
treatment costs by about $1.9 million. In addition, the reduction in 
false positives would produce less anxiety and stress valued at $12.7 
million, and reduced diagnostic costs of $14.5 million. In total, 
quality improvements of 5 percent would generate annual benefits of 
from $182 to $263 million, far exceeding the expected annual compliance 
costs of $38.2 million. From a cost-effectiveness perspective, the cost 
per QALY would amount to about $20,000. Even if the overall quality 
improvement were only 2 percent, the estimated annual benefits of the 
final regulation exceed the estimated annual compliance costs.

C. Small Business Impact

    According to the Small Business Administration, any doctor's 
office, clinic, or hospital with $5 million or less in revenue is 
considered small. In addition, any not-for-profit enterprise that is 
independently owned and operated and not dominant in its field is 
considered small. On this basis, mammography is offered in about 4,800 
small doctor's offices or clinics and 5,000 small hospitals, comprising 
up to 98 percent of all mammography facilities.
    FDA recognizes that the nature of these regulations may have a 
disproportionate effect on very small volume mammography facilities, as 
fixed costs of compliance for equipment improvements are likely to 
increase the cost per mammogram for low volume facilities relatively 
more than for high volume facilities. The cost of a mammogram is 
expected to increase by 3.4 percent in an average facility and by 4.2 
percent in the smallest 10 percent of facilities. However, total 
revenues are also likely to increase. Overall, the annual net revenues 
attributable to mammography (gross revenues minus gross costs) are 
estimated to decline by approximately $1,000 in the smallest 10 percent 
of facilities, whereas the larger facilities may experience net revenue 
gains. ERG judged that these smallest facilities would have an 
increased vulnerability for closure. These results are fully described 
in the agency's final Economic Impact Analysis.
    FDA also examined the effect on small businesses of alternative 
implementation schedules for this proposal. For example, one 
alternative would have required an even more elaborate equipment 
upgrade, effective immediately upon issuance of the regulations. The 
agency rejected this alternative becauseit would have placed an 
unnecessary burden on the industry, costing more than $120 million 
annually. By eliminating some specifications that were marginal to 
ensuring mammography quality, and phasing in certain requirements to 
allow for normal replacement of current equipment, the agency 
substantially reduced the cost of compliance. FDA also considered 
postponing the implementation of the final equipment requirements by an 
additional year. This alternative would have reduced the annual 
compliance costs by $7.1 million, but delay the impact on quality 
improvements. The final implementation schedule was selected as a 
reasonable balance between compliance costs and quality improvements. 
FDA also considered providing an exemption for small facilities in 
shortage areas, but concluded that the importance of mammography 
quality made this tradeoff unacceptable, and that a primary objective 
of MQSA was to ensure quality for all patients. The agency's final 
Economic Impact Analysis includes a discussion of several additional 
alternatives.

D. Total Impact of the MQSA

    The total compliance costs for all of the regulations implementing 
the MQSA are the sum of the costs for the interim rules already in 
place, as well as for the final regulations as estimated above. Thus, 
to assess the total costs of the MQSA, FDA also estimated the costs of 
complying with the interim regulations.
    Interim regulations implementing the MQSA required facilities to be 
accredited by an FDA-approved body as a first step towards receiving a 
certificate. FDA approved the ACR and the States of Iowa, Arkansas, and 
California to accredit facilities. The standards used by these bodies 
to accredit facilities were developed by FDA, but are largely based on 
the standards previously used by the ACR in their voluntary 
accreditation program. Because the ACR was the only national 
accreditation body and had already accredited approximately half of the 
mammography facilities in the country in its voluntary program, the 
majority of unaccredited facilities applied to the ACR for 
accreditation in order to continue to provide mammography services. On 
being notified by the ACR or one of the State bodies that a facility 
was accredited, FDA issued a certificate to the facility.
    Approximately 5,500 facilities had not fully completed the 
accreditation and certification process by October 1, 1994 and 
approximately 1,000 accredited facilities were assumed to incur low 
levels of compliance cost. FDA estimated the costs of compliance with 
the interim rule by dividing these 6,500 facilities (5,500 unaccredited 
and 1,000 accredited) into groups with low, moderate, and high levels 
of noncompliance. Approximately 4,500 of these facilities had completed 
the accreditation and certification process by the end of the 6-month 
period of the provisional certificates or required minor improvements 
to achieve accreditation. These facilities were assumed to have low 
levels on noncompliance. Approximately 1,500 were able to complete the 
accreditation and certification process by the end of a 90-day 
extension of their 6-month provisional certificate. These facilities 
were assumed to have a moderate level of noncompliance. The remaining 
approximately 500 facilities were assumed to have a high level of 
noncompliance.
    Discussions with expert consultants and operators of mammography 
facilities indicated that a low level of noncompliance would typically 
include minor recordkeeping and personnel training deficiencies. A 
moderate noncompliance level would typically include (beyond the low 
level) some quality assurance deficiencies and equipment requiring 
retrofit. Finally, facilities with high levels of noncompliance would 
incur costs for replacement of a mammography unit (in addition to 
``moderate'' costs less retrofit). Based on this methodology, FDA 
estimates the annual costs of the interim rule at about $23.4 million. 
Adding the additional $38.2 million cost attributable to the final 
rules indicates that the total annual compliance costs of the MQSA are 
about $61.6 million.
    The benefits of the interim rules result from their impact on 
mammography quality. A poll of industry experts indicated that the 
interim rules may have improved mammography quality by between 2 and 10 
percent. Other reports have estimated that based on 1992 levels of 
quality, typical community quality levels may have been as much as 13 
percent below the quality levels found in academic or research centers. 
FDA agrees that post-interim levels of quality may be approximately 10 
percent lower than those found in typical academic settings, which 
implies a relative quality gain of 3 percent due to the interim 
regulations. FDA also found that, given average annual compliance costs 
of $23.4 million for the interim regulations, a 3.1 percent quality 
improvement would account for the current level of mammography use (all 
else being equal). Thus, FDA estimates that the interim regulations 
have

[[Page 55968]]

resulted in an approximate 3 percent increase in mammography quality. 
With this assumption, FDA's impact model calculates that the overall 
annual benefits of the interim rule range from $108 to $155 million, 
including the annual gain of about 44 lives and 242 discounted QALY's.

E. Conclusions

    In summary, the final regulations will generate mammography quality 
increases above those already achieved by the interim regulations. As 
shown in the summary table, the annual costs of compliance with these 
final regulations are estimated at $38.2 million. Expected benefits 
will accrue as a result of fewer breast cancer fatalities due to the 
earlier detection of lesions and the avoidance of unnecessary surgery. 
While the magnitude of the expected quality increases are uncertain, an 
improvement of 5 percent in mammography sensitivity and specificity 
would result in annual benefits valued at from $178 to $257 million. 
With respect to all of the MQSA requirements, the annual compliance 
costs of the combined interim and final regulations equal about $61.5 
million, and the annual benefits (assuming total quality increases of 8 
percent) range from $284 to $408 million.

                                                    Table 1.--Summary of Economic Impacts (million $)                                                   
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                   Interim Rule\1\           Final Rule\2\               Total\3\       
--------------------------------------------------------------------------------------------------------------------------------------------------------
Compliance Costs                                                                                  23.4                     38.2                     61.6
Benefits                                                                                   108.2-153.8              181.7-262.7              289.9-416.5
Diagnostic Cost Decreases                                                                          9.0                     14.5                     23.5
Treatment Cost Decreases                                                                           1.1                      1.9                      3.0
Anxiety Cost Decreases                                                                             7.8                     12.7                     20.5
Value of Lives Extended                                                                     90.3-135.9              152.6-233.6              242.9-369.5
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\Assumes 3 percent increase in mammography quality                                                                                                    
\2\Assumes 5 percent increase in mammography quality                                                                                                    
\3\Assumes 8 percent increase in mammography quality                                                                                                    

F. Responses to Comments on the Impact Analysis of the Proposed 
Regulation

1. Cost Analysis
    FDA published a preliminary impact analysis in association with the 
final regulations on April 3, 1996. Public comments were invited on the 
methodology and projections included in that analysis.
    One comment disagreed with the cost-benefit analysis and stated 
that the imposition of additional costs would adversely affect public 
health because fewer women will be able to receive the benefits of 
mammography.
    FDA agrees that additional costs with no concurrent quality 
improvement may adversely affect mammography access. FDA also 
recognizes that access without quality is of no public benefit. FDA 
believes, however, that the assurance of quality resulting from these 
regulations will overcome any possible negative impacts. This belief is 
supported by a CDC study on mammography utilization that showed a 
continued increase in screening mammography examinations under the MQSA 
interim rules (Ref. 4).
    One comment stated that most CEU classes for technologists cost 
between $75.00 and $100.00 for 6 to 8 credits, and require additional 
travel expenses. FDA agrees with the estimate provided by this comment. 
FDA estimated that the cost per hour of technologist's CEU would cost 
approximately $16.00 per credit hour and used this estimate in its 
impact analysis. This estimate was based on input from consultants and 
is within the range presented by this comment.
    Numerous comments stated that the Federal Register notice for the 
proposed rule lacked sufficient methodological detail and should have 
included the cost of each requirement and the per facility or per 
procedure cost.
    FDA agrees that the summary of impacts included in the Federal 
Register did not include detailed methodologies, discussions of 
assumptions, and sources of data. Nevertheless, as is required, FDA had 
provided a clear explanation of the calculations used for the cost/
benefit analysis in the Full Regulatory Impact Analysis which was 
available for review at the Dockets Management Branch. Similarly, the 
agency's final Economic Impact Analysis, which provides substantial 
detail on the cost estimates is available at the same location that 
document can also be retrieved from FDA's home page on the World Wide 
Web (www.fda.gov).
    A number of comments asserted that the equipment requirements would 
mandate the replacement of most mammography units and would increase 
the cost of these replacement units and that these costs were 
underestimated by FDA. One comment calculated the cost of replacing 
15,000 mammography units, priced at $70,000, at more than $1 billion. 
The comment also calculated the cost of replacing 5,000 processors (\1/
2\ of total), priced at $15,000, at $75 million.
    FDA disagrees with the assumption that all mammography units in the 
country (which actually number about 12,000 instead of 15,000) or even 
most units will have to be replaced in order to meet the final rules. 
The Economic Impact Analysis that accompanies this final rule includes 
a detailed discussion on the estimation of the replacement costs. FDA 
has estimated the costs of the equipment requirements of the proposed 
rule by estimating replacement and retrofit costs through contacts with 
mammography equipment manufacturers. For replacements, the analysis 
considers the lost useful life of the machine. FDA also solicited input 
on compliance costs from mammography unit manufacturers and project 
consultants. These manufacturers indicated that not all mammography 
units would require replacement or retrofit and that prices for the new 
units would be identical to current prices. Based upon these sources of 
information, FDA estimated the total costs related to the equipment 
requirements of the proposed regulations to be approximately $270 
million or $35 million in average annual costs (over the 10-year 
analysis period at a 7 percent discount rate). The agency notes that, 
after consideration of the public comments and other information, a 
number of equipment requirements, including those related to 
processors, were deleted before these regulations were issued. The 
impact of those deletions was to reduce the total estimated expenditure 
of meeting the equipment requirements in lost resources to $241 million 
and the average annual costs over the 10-year analysis period to $28.5 
million.

[[Page 55969]]

    One comment stated that phasing in equipment requirements 5 and 10 
years after the effective date of the regulations would significantly 
increase costs if facilities are required to replace the unit in 5 
years and then again in 10 years.
    FDA believes that this comment stems from a misinterpretation of 
the proposal. FDA did not expect facilities to replace units every 5 
years. Input on the equipment requirements from manufacturers indicated 
units would be available almost immediately after the regulations were 
published that would be able to meet the 5- and 10-year requirements. 
Thus, if a unit had to be replaced to meet an immediate requirement, a 
new unit could be selected that would meet the 5- and 10-year 
requirements as well. The facility would not need to purchase 
additional replacement units ``every 5 years.'' FDA's purpose in 
phasing in some requirements 5 and 10 years in the future was to 
provide time for facilities whose units met the immediate requirements 
but not the 5- or 10-year requirements to replace those units on their 
regular replacement schedule. This would decrease the burden by 
allowing machines to be replaced as they reach the end of their useful 
life. However, for reasons discussed in the responses to the comments 
on the equipment requirements, most of the 5-year requirements and all 
of the 10-year requirements were removed before these final regulations 
were issued.
    Two comments expressed concern that the cost requirements for 
training every technologist to perform weekly or daily phantom checks 
were not considered in the impact analysis of the proposed regulations. 
Another comment estimated that the cost of performing the daily phantom 
tests for 240 days per year at $0.80 per sheet of film would be an 
additional $192.00 per unit. Using the estimated 10,800 certified units 
this would mean an additional cost of $2,073,600 per year.
    FDA notes that the weekly phantom tests are identical to those 
currently being performed monthly under the interim regulations. No 
additional training costs will be incurred beyond those already 
included in the cost estimates of the interim regulations. FDA did not 
include any cost requirements for training to perform the daily phantom 
checks or for performance of the test because the agency did not 
propose such a test but merely requested public comment on its possible 
value. As previously discussed, FDA concluded from the public comments 
that further studies would be needed to confirm the value of such a 
test before it was made a regulatory requirement. Because it was not 
made a regulatory requirement, no costs either for training in its 
performance or performing the test needed to be included in these cost 
estimates.
    A number of comments stated that FDA underestimated costs by not 
considering all of the factors that will contribute to increased 
provider and consumer cost.
    FDA's Economic Impact Analysis has attempted to consider all of the 
factors that will contribute to increased costs from compliance with 
the final rule. This analysis is available through the Dockets 
Management Office, as well as the World Wide Web. As these comments did 
not identify the factors believed to have been overlooked, the agency 
is unable to give a more specific response.
    Numerous comments asserted that the cost of lay notification would 
significantly increase the costs of mammography. These comments 
estimated that the cost ranged from $0.78 to $15.00 per notification.
    For the proposed rule, FDA used a methodology to estimate the cost 
of patient notification that is similar to that described in the 
comments. The Economic Impact Analysis presented an estimate of $0.94 
per written notification including 2.5 minutes of an office staff 
worker's time and cost of postage. However, this proposed requirement 
was removed from the final rule before it was codified, so these 
estimated costs will not occur.
    A number of comments stated that the increased costs to comply with 
the final rule will result in facility closings (especially for small-
volume facilities and rural facilities) and loss of access. One comment 
also stated that FDA has not adequately justified the cost of the 
regulation in the face of reducing access to low income populations.
    FDA agrees that it is possible that increased costs of conducting 
mammography due to these regulations may cause some facilities to close 
if those facilities are currently not offering high quality 
mammography. However, FDA disagrees that such an impact has not been 
adequately explored. FDA has attempted to identify areas of potential 
access problems and believes that very few patients would be adversely 
affected if, as is anticipated, few, if any, facilities close as a 
result of the burdens of the final regulations. When facilities do 
close, alternate facilities are usually expected to be available within 
a reasonable distance. The agency also notes that the GAO study cited 
earlier found that the interim regulations, which had a similar cost 
impact, had little impact on access. FDA agrees that access for low 
income women is a potential problem, but does not believe that these 
regulations will greatly increase this problem. Nevertheless, FDA will 
monitor this potential outcome to ensure that any adverse impact on 
underserved populations is minimized.
    One comment stated that costs were underestimated because only the 
incremental costs of nonvoluntary compliance were identified.
    FDA disagrees with this comment. The quality standards contained in 
these regulations reflect standards of good practice, so it would not 
be surprising to find that many facilities were already complying with 
them before the regulations went into effect. Where voluntary 
compliance with regulatory requirements existed prior to implementation 
of the rule, costs were not included in the agency's Economic Impact 
Analysis because they are due to the facility's own desire to achieve 
quality mammography and not to the regulations. FDA agrees that if 
compliance costs occur only as a result of or in anticipation of a 
regulation and would be discontinued in its absence, such costs should 
be considered. However, FDA believes that most mammography facilities 
did not anticipate the specific regulatory requirements of this rule, 
and so any past actions to improve quality at their facilities were 
independent actions on their part.
    Several comments noted that the proposal included only costs 
associated with the proposed regulations and not the interim rule. They 
stated that the costs and benefits of the entire MQSA should be 
estimated.
    FDA agrees with these comments and has included estimates of the 
interim impacts for these final regulations.
    One comment noted that costs may be understated because FDA assumed 
the lowest compliance cost. This comment stated that because some 
facilities would incur higher costs, the overall costs were 
underestimated.
    FDA disagrees with this comment. The agency assumed that each 
facility would adopt a least-cost compliance strategy, which is 
standard economic methodology for analysis of regulations as required 
by Executive Order 12866. While some facilities would have higher 
costs, other facilities would have lower (or no) costs. Thus, the 
least-cost method of compliance for the average facility is a 
reasonable method of estimating industry wide costs. It is possible 
that this comment misunderstood the methodology used to estimate costs.

[[Page 55970]]

    One comment stated that FDA has not adequately accounted for 
decreases in mammography usage due to expected cost increases.
    FDA has attempted to address this issue for the final regulations. 
FDA agrees that cost increases are likely to decrease mammography use, 
all else being equal, but that perceived increases in mammography 
quality are likely to offset any negative impact. This issue is 
discussed above in B.2 and in the Economic Impact Analysis that 
accompanies the final rule.
    One comment asserted that FDA's costs were ``unrealistic,'' rely 
only on consultant opinion and are, therefore, unreliable.
    FDA disagrees with this comment. Cost estimates were derived from 
an extensive process of site-visits and expert input and no alternative 
data were included with this comment. The agency's cost methodology is 
fully detailed in the Economic Impact Analysis.
    Several comments noted that specific activities were 
underestimated. FDA cannot respond to these comments because no 
supporting data were supplied.
2. Benefits Analysis
    A number of comments maintained that FDA overstated the expected 
improvement in avoiding cancer deaths from the final regulation and 
that the benefit estimates should be based on scientific literature.
    FDA believes that quality improvements in mammography will result 
in health gains, of which reductions in breast cancer mortality are a 
major contributor. FDA has attempted to assess the potential quality 
gains from the requirement of the final rule by reviewing relevant 
literature and through contact with experts in mammography quality. The 
Economic Impact Analysis that accompanied the proposed regulations 
included a detailed and referenced description of the benefits 
estimate. Similarly, the analysis of impacts for the final regulations 
include, a comprehensive description of the methodology.
    One comment maintained that the final rule was a waste of money 
because the ACR program has already accomplished a goal of ``reasonably 
achievable mammographic quality.''
    FDA disagrees with this comment. While voluntary accreditation by 
ACR did much to improve quality in participating facilities, the agency 
notes that, at the time of passage of the MQSA, less than half of the 
mammography facilities in the country had sought voluntary 
accreditation. The MQSA and its implementing regulations have led to 
the establishment of a uniform minimum set of quality standards to be 
met by all mammography facilities, including standards in areas not 
previously covered by the ACR program, and have provided increased 
assurance that these standards continue to be met between the times of 
accreditation. As shown in the above impact analysis, the agency 
believes that the benefits achieved more than compensate for the 
additional costs.
    One comment stated that there has been a significant improvement in 
the quality of mammography performed under the interim regulations and 
further maintained that this quality improvement will continue under 
the final regulations.
    FDA agrees with this comment. Quality improvements attributable to 
the interim regulations are estimated in conjunction with those 
attributable to the final regulations.
    Several comments stated that because sensitivity is defined as the 
number of true positives divided by the number of true positives plus 
false negatives, a gain in sensitivity rate would have no effect on the 
false positive rate.
    FDA agrees with these comments. FDA believes that both false 
negatives and false positives would be reduced by the quality 
improvements expected from these regulations. Thus, FDA believes that 
expected quality improvements would be likely to improve both 
sensitivity and specificity of screening mammography examinations. FDA 
notes that a typographical error in the analysis of impacts 
accompanying the proposed regulations may have contributed to these 
comments.
    One comment stated that the discussion on sensitivity confuses the 
notion that there are inherent tradeoffs between sensitivity and 
specificity with the mathematical reality that this is not necessarily 
the case. The respondent believed also that this error may be due to 
confusing sensitivity with PPV.
    FDA recognizes that the sensitivity and the PPV of a diagnostic 
test are not identical. Nonetheless, FDA believes that sensitivity and 
specificity provide reasonable quality measures for evaluating these 
final regulations.
    Several comments stated that there is an error in the benefits 
analysis where it states, ``a five percent gain in sensitivity 
measurements of 80 percent would indicate a revised sensitivity level 
of 81 percent (a reduction of the rate of false positives from 20 to 19 
percent).'' The comments stated that 5 percent gain to 80 is 84 not 81.
    FDA agrees that the description of the impact was not well stated. 
A 5 percent quality improvement is defined in FDA's analysis as a 5 
percent reduction in inaccurate testing results. Thus, if 20 percent of 
the diseased, screened population are currently not identified, a 5 
percent quality improvement would see 19 percent not identified. The 5 
percent is actually a 5 percent reduction in the complement of 
sensitivity.
    Numerous comments asserted that the estimated willingness to pay to 
avoid a statistical loss of life of $5 million was too high and was 
unsupported.
    FDA disagrees with these comments. For illustrative purposes, FDA 
has quantified the decreased breast cancer mortality potentially 
resulting from the rule using an average value of $5.0 million per each 
avoided death. This value is the implied value of society's willingness 
to pay to avoid the likelihood of an additional death as derived from 
economic literature, as referenced in the full Economic Impact 
Analysis. The methodology used to estimate this value is based on wage-
premiums necessary to induce workers to accept riskier occupations and 
is a commonly used approach for estimating the value that society 
appears to be willing to pay to avoid a statistical death.
    Several comments questioned the probability of expected benefits 
accruing from improvements in specificity. The comments identified this 
as the area where the greatest cost savings could be realized, and 
underlined this area as one which should be a target for improvement by 
the MQSA. Relatively small improvements in specificity could markedly 
reduce the numbers of false positive results nationwide, resulting in 
less diagnostic testing.
    FDA agrees with these comments. These cost savings were addressed 
for the proposed regulations and are addressed for these final 
regulations.
    One comment stated that raising the sensitivity of a test results 
in an increase in the false positives rather than a decrease.
    FDA disagrees. The agency finds that quality improvements made to 
comply with the final rule are likely to improve sensitivity and/or 
specificity by raising the typical community receiver operating 
characteristic curve toward the optimum level. That is, quality 
improvements due to these regulations would change the entire 
relationship between sensitivity and specificity by improving the 
production function of mammography. As a result, both measures would be 
improved by these regulations.

[[Page 55971]]

    One comment questioned the use of identified cancer stages used in 
the benefit analysis and noted that there is controversy associated 
with the impact of ductal carcinoma in situ on health outcomes.
    FDA agrees with this comment and adjusted the benefit analysis for 
the final regulations.
    One comment asserted that benefits were overstated because the 
general trend in mammography was toward higher quality even in the 
absence of the regulations.
    FDA disagrees that the beneficial impact of these regulations has 
been overstated. Current trends in mammography quality are accounted 
for in baseline conditions.
    Several comments noted areas of potential benefit that were not 
accounted for in the analysis that accompanied the proposal. These 
areas include the benefit of increased assurance to patients, the 
benefits of increased diagnostic quality, and reductions in treatment 
costs for identified cancers.
    FDA agrees with these comments and has included these categories in 
this final analysis.
    One comment stated that references for the benefit analysis were 
not available. FDA notes that references were included with the 
Economic Impact Analysis that accompanied the proposed regulations.
    One comment noted that the affected population would change over 
time and that FDA has assumed a static population.
    FDA agrees with this comment. FDA notes, however, that forecasting 
changes in future populations would likely increase the expected 
benefits because of the age distribution changes expected as the baby 
boom generation moves into ages of greater risk from breast cancer.
    Several comments questioned the assumptions used in FDA's benefit 
estimation model.
    FDA agrees that several of the key assumptions are uncertain. 
Nevertheless, the agency believes that the absence of scientific 
certainty does not preclude the development of preamble projections 
based on reasonably supported amplifying assumptions. The Economic 
Impact Analysis for these final rules provides sensitivity analyses 
that demonstrate the effects of modifying a number of these variables.

VI. Paperwork Reduction Act of 1995

A. Information Collection Provisions in the Final Rule

    This final rule contains information collection provisions that are 
subject to review by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
following title, description, and respondent description of the 
information collection provisions are shown with an estimate of the 
annual reporting and recordkeeping burden. Included in the estimate is 
the time for reviewing instructions, searching existing data sources, 
gathering and maintaining the data needed, and completing and reviewing 
each collection of information.
    Title: Reporting and Recordkeeping Requirements for Mammography 
Facilities.
    Description: The final rule collects information from accrediting 
bodies and mammography facilities. Under the final rule, each 
accreditation body is required to submit applications and establish a 
quality assurance program. Each mammography facility is required to 
establish and maintain a medical reporting and recordkeeping system, a 
medical outcomes audit program, a consumer complaint mechanism, and 
records documenting personnel qualifications.
    These information collection requirements apply to accreditation 
bodies and to mammography facilities. In order to be an approved 
accreditation body, private nonprofit organizations or State agencies 
must submit an application to FDA and establish procedures and a 
quality assurance program. Mammography facilities must obtain and 
prominently display an FDA-issued certificate or provisional 
certificate; have a medical reporting and recordkeeping program, a 
medical outcomes audit program, and a consumer complaint mechanism; and 
maintain records documenting personnel qualifications. These actions 
are being taken to ensure safe, accurate, and reliable mammography on a 
nationwide basis.
    Respondent Description: Businesses and other for-profit 
organizations, nonprofit organizations, Federal, State, and local 
governments.
    FDA estimates the burden of this collection of information as 
follows:

Requirements for Accreditation Bodies of Mammography Facilities and 
Quality Standards and Certification Requirements for Mammography 
Facilities; General Facility Requirements

                                                       Table 2.--Estimated Annual Reporting Burden                                                      
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                               Total    
                                              No. of          Annual       Total Annual      Hours per                     Total Capital    Operating & 
             21 CFR Section                 Respondents    Frequency per     Responses       Response       Total Hours        Costs        Maintenance 
                                                             Response                                                                          Costs    
--------------------------------------------------------------------------------------------------------------------------------------------------------
900.3                                           6               1               6              60             360                                       
900.3(b)(3)                                    10               1              10              60             600             $50                       
900.3(c)                                        4               0.14            0.56           15               8.4                                     
900.3(e)                                        1               0.2             0.2             1               0.2                                     
900.3(f)(2)                                     1               0.2             0.2           200              40                                       
900.4(c) and (d)\1\                           834               1             834               1             834                                       
900.4(e)\2\                                10,000               1          10,000               8          80,000                                       
900.4(f)\3\                                 1,000               1           1,000              14.5        14,500                                       
900.4(h)\4\                                     6               1             750               6           4,500                                       
900.4(i)(2)                                     1               1               1               1               1                                       
900.6(c)(1)                                     1               1               1               1               1                                       
900.11(b)(2)                                   25               1              25               2              50                                       
900.11(b)(3)                                    5               1               5                .5             2.5                                     
900.11(c)                                  10,000               0.0050         50              20           1,000                          $1,000       
900.12(c)(2)                                  100               1             100               5             500                                       
900.12(j)(1)                                   10               1              10               1              10                                       
900.12(j)(2)                                    1               1               1              50              50                                       
900.15(d)(3)(ii)                           10,000               0.0020         20               2              40                            $100       
900.18(c)                                  10,000               0.0005          6               2              12                             $60       

[[Page 55972]]

                                                                                                                                                        
900.18(e)                                      10               0.1000          1               1               1                             $10       
TOTAL                                                                                                     102,510             $50          $1,170       
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\Formerly Sec.  900.4(b) under the interim rule.                                                                                                      
\2\Formerly Sec.  900.4(d) under the interim rule.                                                                                                      
\3\Formerly Sec.  900.4(e) under the interim rule.                                                                                                      
\4\Formerly Sec.  900.4(g) under the interim rule.                                                                                                      

Requirements for Accreditation Bodies of Mammography Facilities and 
Quality Standards and Certification Requirements for Mammography 
Facility Requirements; General Facility Requirements and Personnel 
Requirements

                                 Table 3.--Estimated Annual Recordkeeping Burden                                
----------------------------------------------------------------------------------------------------------------
                                                                                                       Total    
                      No. of          Annual       Total Annual      Hours per                      Operating & 
 21 CFR Section    Recordkeepers   Frequency per      Records      Recordkeeper     Total Hours     Maintenance 
                                   Recordkeeping                                                       Costs    
----------------------------------------------------------------------------------------------------------------
900.3(f)(1)            10             130           1,300             200           2,000                       
900.4(g)\1\        10,000               1          10,000               1          10,000                       
900.11(b)(1)\2\     1,000               1           1,000               1           1,000                       
900.12(c)(4)\3\    10,000               1          10,000               1          10,000                       
900.12(e)(13)       6,000              52         312,000               0.125      39,000                       
900.12(f)          10,000               1          10,000               1          10,000                       
900.12(h)          10,000               2          20,000               0.5        10,000         $20,000       
TOTAL                                                                              82,000         $20,000       
----------------------------------------------------------------------------------------------------------------
\1\Formerly Sec.  900.4(f) under the interim rule.                                                              
\2\Formerly Sec.  900.11(c)(1) under the interim rule.                                                          
\3\Formerly Sec.  900.12(e)(1) under the interim rule.                                                          

    Most of this burden is not new, but rather results from 
requirements continued from the interim rule. FDA estimated the annual 
burden for reporting and recordkeeping requirements under the interim 
rule to be 120,944 hours (58 FR 67562 and 67569). The additional 
requirements contained in these final rules will add 63,566 burden 
hours to this estimate, resulting in an estimated total annual burden 
of 184,510 hours.
    The burden estimate for this final rule differs from the proposed 
rule in several respects (see 61 FR 14865 to 14868). First, FDA revised 
Sec. 900.12(c)(2), which proposed written notification of examination 
results to all mammography patients. The final rule requires that each 
facility maintain a system to ensure that the results of each 
mammographic examination are communicated to the patient in a timely 
manner. This revision resulted in the removal of proposed 
Sec. 900.12(c)(2)(i) from the paperwork burden estimates. Second, FDA 
revised Sec. 900.12(d)(2), which proposed the specific documentation to 
be maintained by each facility as part of its quality assurance 
program. This revision included removing Secs. 900.12(d)(2)(i), 
900.12(d)(2)(ii) and 900.12(d)(2)(iii) from the final rule and 
combining Secs. 900.12(d)(2) and 900.12(d)(2)(iv) from the proposed 
rule into Sec. 900.12(d)(2) for the final rule. This revision is 
reflected in these estimates of the recordkeeping burden. Third, FDA 
added several reporting and recordkeeping burden estimates that are not 
new to the final rule, but whose impact was overlooked in the burden 
estimate for the proposed rule. Also, FDA renumbered some of the 
provisions for the final rule, due to removal or additions of other 
provisions; these revisions had no effect on the paperwork burden 
estimates. The following sections concerning paperwork burden were 
renumbered: Sec. 900.4(a)(7) in the proposed rule is Sec. 900.4(a)(6) 
in the final rule, and Secs. 900.12(f)(2) and 900.12(f)(4) in the 
proposed rule are Secs. 900.12(f)(1) and 900.12(f)(3) in the final 
rule, respectively.

B. Comments on the Paperwork Reduction Act Statement

    As required by section 3506(c)(2)(B) of the Paperwork Reduction 
Act, FDA provided an opportunity for public comment on the information 
collection provisions of the proposed rule (April 3, 1996). A small 
number of comments addressed FDA's Paperwork Reduction Act statement. 
In general, these comments asserted that FDA had underestimated burden 
or had not considered all of the reporting and recordkeeping 
requirements.
    One comment stated that FDA's Paperwork Reduction Act statement 
underestimated the time burden on mammography facilities for 
recordkeeping and reporting. The comment further stated that FDA's 
estimate of 23,553 hours, which translated into less than 2.5 hours per 
facility (based on an estimated 10,000 mammography facilities in the 
United States), was low. The comment asserted that FDA underestimated 
or ignored the incremental burden on facilities from the interim rule 
to the final rule. The comment further stated that at least one person 
at each mammography facility

[[Page 55973]]

must understand the final rule. The author of the comment estimated 
this task at 10 hours per person at each of the estimated 10,000 
mammography facilities.
    FDA disagrees with this statement in general, but upon review of 
the burden estimates under the proposed rule FDA has revised some of 
the time estimates. For example, FDA has added hours to cover 
Sec. 900.12(e)(3)(13), infection control, because its burden was 
overlooked under the paperwork burden analysis of the proposed rule.
    FDA also agrees that someone in the mammography facility will have 
to understand the final rule and that it will take some time to develop 
this understanding. The agency believes, however, that the time 
estimate suggested by the comment is far too high. This belief is based 
upon three considerations. First, the basic framework of the 
requirements has not significantly changed from the interim rule. Many 
of the additional details in the final rule are taken from policies 
developed under the interim rule, with which the facilities are already 
familiar. Because of this overlap, the time required to understand the 
final rule is less than it would be if they were entirely new. Second, 
the recordkeeping and reporting burdens are estimated on an annual 
basis; therefore, each estimate is stated as an average time per year. 
Whatever burden there would be in understanding the new regulations 
would be primarily a one-time burden. If an individual spends x hours 
the first year developing an understanding of the regulations, the time 
required in the second and subsequent years will be much less than x 
because the person will already be familiar with them. The average time 
per year for understanding the regulations thus would be only a small 
fraction of x. Third, in compliance with the Paperwork Reduction Act, 
it is the time burden for reporting and recordkeeping that is being 
estimated. Thus, only the time required to understand the new reporting 
and recordkeeping requirements, not to understand the total 
requirements, would properly be included in these estimates. The 
combined effect of these three factors, the agency believes, reduces 
the time burden for understanding the requirements that should be 
included in these estimates significantly. The burden for understanding 
each requirement has been included in the individual burden estimates 
for that requirement.
    One comment stated that FDA had not estimated any burden for 
compliance with proposed Sec. 900.12(f), which requires each facility 
to implement a medical outcomes audit. The author of the comment 
estimated that the burden of such a requirement would require at least 
10 hours of an interpreting physician's time at each of the estimated 
10,000 mammography facilities. Several other comments also stated that 
proposed Sec. 900.12(f) was an undue burden on freestanding facilities. 
The comments discussed the difficulty in tracking down and obtaining 
all biopsy and consultation outcomes. One comment noted the lack of 
evidence that outcome measurement contributes to improved care.
    FDA understands the difficulty with tracking outcomes data but such 
data are critical in assessing the quality of mammography at 
facilities. FDA also notes that most of the requirements in 
Sec. 900.12(f) do not require any additional reporting or recordkeeping 
burden beyond what was required under the interim rule.
    One comment also asserted that FDA had failed to include the time 
burden for proposed Sec. 900.12(g), which adds requirements for 
mammography of patients with breast implants. The comment stated that 
FDA should have estimated the time burden related to scheduling 
patients with implants, documenting patients with implants, and 
requiring the presence of an appropriately trained interpreting 
physician onsite during mammography of women with implants. The author 
of the comment estimated that the above would require an additional 10 
to 20 hours of reporting and recordkeeping at each mammography 
facility.
    As discussed previously, FDA has changed the proposed requirement 
that each facility should inquire whether a patient has an implant at 
the time of scheduling to a requirement in the final rule that each 
facility shall inquire as to whether the woman has an implant prior to 
the examination. The final rule also eliminated the requirement that an 
interpreting physician be present. Even under the proposal, the 
additional recordkeeping time would have been minimal and the revision 
in the final rule gives the facility flexibility in determining when 
and how the information is collected for the patient's record. All 
facilities maintain patient records with information such as address, 
telephone number, insurance information, and medical history. The 
additional time to ask a yes or no question on implants and record the 
answer is negligible.
    Another comment stated that FDA had failed to estimate the 
additional requirements and documentation associated with personnel 
requirements in proposed Sec. 900.12(a). The comment estimated that 
additional documentation requirements would necessitate at least 5 
hours of additional time for approximately 1,000 medical physicists, 
and approximately \1/4\ hour for each mammography facility.
    FDA acknowledges that Sec. 900.12(a) contains some increases in the 
required level of personnel training and experience from the interim 
rule. However, FDA did not include any recordkeeping burden estimates 
for the personnel requirements under either the interim or final rules 
because the agency believes that it is usual and customary practice for 
mammography facilities to keep records of the qualifications of their 
employees.
    Although this position makes moot the question of the amount of 
time required for recordkeeping related to these requirements, FDA 
would like to note that there are factors that the author of the 
comment may not have been aware of that make the estimates in the 
comment excessive. Most changes in the personnel qualifications are 
only increases in the amounts of the interim requirements. In such 
cases there is no additional recordkeeping burden. It requires no more 
effort, for example, under the final rule, to keep a letter in a 
doctor's records indicating that he or she had 3 months of training in 
mammography during residency that it did, under the interim rule, to 
keep a letter indicating he or she had 2 months of such training.
    For most of the new personnel requirements in the final rule, such 
as the continuing experience requirements for technologists and 
physicists, the information that bears on whether these requirements 
are met often already exists in the form of various work records. All 
that is needed is to place a copy or summary in each person's file.
    The remaining new standard establishes an initial requirement of a 
minimum level of education and training for medical physicists. FDA 
believes that the majority of physicists providing services to 
mammography facilities will have exceeded this level in meeting the 
requirement that the medical physicist be board-certified, State 
licensed, or State approved, which was retained from the interim rule. 
In such cases, the agency intends to minimize the burden by accepting 
the documentation of board approval, State licensure, or State approval 
(in States whose standards for approval exceed the minimum level) as 
adequate evidence that the second requirement is also met.
    Physicists approved by States that require a level of qualification 
for approval lower than that in the second

[[Page 55974]]

requirement will have to provide additional documentation but the time 
required is likely to be significantly less than the 5 hours estimated 
in the comment. More importantly, as this is an initial requirement, it 
will be a one time burden. To be compared with the other burden 
estimates, it must be averaged over the physicists's entire career, 
which could be 30 years or longer.
    Again, because keeping records of personnel qualifications is usual 
and customary practice, FDA has not included this in the burden 
estimates. The agency notes, however, for the reasons discussed above, 
that the comment greatly overestimates the time required for the new 
recordkeeping.
    One comment stated that virtually all of the requirements in the 
proposed rule duplicate requirements of accreditation bodies and noted 
that FDA inspectors require much of the same personnel documentation 
required by the ACR.
    FDA notes that the author of the comment has misunderstood the 
nature of the accreditation system required under the MQSA. The 
requirements of the FDA-approved accreditation bodies are not 
established by those bodies but rather are FDA-established quality 
standards that the accreditation bodies, as a condition of their 
approval, must ensure are met by the facilities they accredit. Thus, 
there is only one set of requirements, not two or more duplicate sets, 
and the actions identified in the comment are mandated by the 
legislation in order to increase the likelihood that quality 
mammography will be consistently achieved.
    Several comments asserted that the proposed rule would create an 
unnecessary amount of paperwork that would ultimately take away from 
time with patients. One comment asserted that the reporting 
requirements would necessitate a computer system and additional 
clerical support.
    FDA has attempted to limit the paperwork burden to only those 
recordkeeping and reporting requirements necessary to ensure that 
facilities meet minimum quality standards. As discussed above, FDA has 
also reduced the paperwork burden of the final rule by removing several 
reporting and recordkeeping requirements from the final rule. The 
agency believes that the paperwork impact, as estimated in Tables 1 and 
2, is not unreasonable in view of the benefits to be gained from the 
quality standards that made the recordkeeping and reporting necessary.
    A number of comments asserted that proposed Sec. 900.12(c)(2), 
which would have required written notification of mammographic 
examination results to all mammography patients, would cost time and 
postage expenses and would generate much paperwork. Some comments 
asserted that this practice would be redundant for patients with 
referring physicians who could explain the results.
    FDA has revised Sec. 900.12(c)(2) to require that each facility 
shall maintain a system to ensure that the results of each mammographic 
examination are communicated to the patient in a timely manner. FDA has 
allowed for increased flexibility in the notification of patients by 
allowing written or other notification by either the mammography 
facility or the referring physician. FDA believes that some form of 
patient notification is a standard of good practice that is currently 
followed voluntarily by virtually all mammography facilities, so the 
burden of this requirement will fall only on those few facilities who 
are not currently meeting such a standard. The flexibility of 
notification method allowed under the revision of Sec. 900.12(c)(2) 
will make the burden minimal even for these facilities.
    Several comments asserted that proposed Sec. 900.12(h), which 
requires the development of a consumer complaint mechanism, was 
unnecessary. The comments stated that all complaints should be handled 
on an individual basis at each facility according to the protocol of 
that facility. One comment asserted that the proposed rule would be 
very costly in terms of staff time and materials.
    This comment has misinterpreted the requirements of Sec. 900.12(h), 
which gives facilities the flexibility to develop their own consumer 
complaint mechanism in the manner they feel most appropriate. The 
requirement that each facility must maintain records of each serious 
complaint over the last 3 years should be of minimal burden to 
facilities and would only necessitate a file including the appropriate 
correspondence by the complainant, facility, and accrediting body. Many 
facilities already have some form of consumer complaint mechanism and 
would not incur significant additional burden by meeting the 
requirements of the final rule.
    One comment agreed with proposed Sec. 900.12(c)(4)(ii), which 
states that facilities must transfer mammographic films and records to 
other facilities or the patient at the patient's request, but stated 
that it was not economical or practical to copy films for the sake of 
keeping them in the patient's medical record.
    FDA notes that Sec. 900.12(c)(4)(ii) does not require that a 
facility maintain copies of a patient's medical records if the patient 
has asked to have them transferred elsewhere. The facility is free to 
determine for itself whether it is desirable to copy films for its own 
records.
    Several comments stated that proposed Sec. 900.4(c), which requires 
clinical image review as part of the accreditation and reaccreditation 
process, would be extremely costly and time-consuming. This burden 
includes the time and expense of choosing the images and having them 
copied and mailed. Another comment supported clinical image review as 
the best approach for a performance-based standard, but also stated 
that it would be costly and time-consuming.
    FDA notes that Congress specifically required clinical image review 
as part of the accreditation and reaccreditation process (42 U.S.C. 
263b((e)(1)(B)(i)), because clinical image review is necessary to 
ensure high quality mammography. While it may appear that the 
complexity of the process, and thus of the burden, has increased due to 
the increased detail in the final rule, these details are presently 
being followed as policy by the accreditation bodies so, in fact, there 
is no additional burden. The agency further notes that facilities are 
not required to copy the films before sending them for review. Only 
original films are reviewed and these are returned to the facility 
after the review is complete.
    Several comments stated that Sec. 900.12(e)(13), requiring 
facilities to establish an infection control procedure including 
documentation after each cleaning, would create needless paperwork and 
would not affect quality assurance.
    FDA has included an additional paperwork burden estimate for this 
requirement in the final rule. Under Sec. 900.12(e)(13), facilities are 
required to establish and comply with a system for cleaning and 
disinfecting equipment as needed. Although there is no evidence that 
blood-borne pathogens have been transmitted from patient to patient 
during mammography, there is a theoretical possibility of such a 
transmission. That agency believes the time required is justified to 
ease concerns about such a possibility, concerns that in some cases may 
cause patients to refuse to undergo mammography examinations and thus 
possibly lose the life-saving benefit of early detection of breast 
cancer.
    The information collection provisions of this final rule have been 
submitted to OMB for review. Prior to the effective date of this rule, 
FDA will publish a notice in the Federal Register announcing OMB's 
decision to approve,

[[Page 55975]]

modify, or disapprove the information collection provisions in this 
final rule. An agency may not conduct or sponsor, and a person is not 
required to respond to, a collection of information unless it displays 
a currently valid OMB control number.

Appendix

Excerpts from Chapter 4 of AHCPR's ``Quality Determinants of 
Mammography;'' Guidelines for Communicating Test Results

    As noted previously, FDA recommends that mammography facilities 
utilize the AHCPR'S guidelines in ``Quality Determinants of 
Mammography'' with respect to written notification of results to 
patients. The pertinent information from Chapter 4 of those guidelines 
is reprinted here for ease of reference. The symbol [R] indicates that 
the AHCPR document provides an additional reference or references at 
that point.

COMMUNICATING RESULTS

    RECOMMENDATION: The referring health care provider and the 
interpreting physician should be sensitive, supportive, and 
appropriate in communicating results, as well as prompt and 
accurate. (B)
    STRONG RECOMMENDATION: An appropriate professional at the 
mammography facility, usually an interpreting physician, should send 
the woman's health care provider a written report documenting the 
specific findings, follow up recommendations, and the name of the 
interpreting physician. The facility should directly telephone the 
referring provider if the result is suspicious for cancer. (B)
    STRONG RECOMMENDATION: The mammography facility personnel should 
give the woman written notification of the results of her 
mammography and other breast imaging, either on site or by mail. The 
results should be in simple language, document the name of the 
interpreting physician, be given in a timely fashion, and include 
further steps to be taken. (B)
    RECOMMENDATION: If a facility accepts women who have no health 
care provider, facility personnel should give the woman a list of 
qualified providers who are willing to provide care. The name, 
address, and phone number of the provider chosen should be recorded, 
if possible (C).
    STRONG RECOMMENDATION: The facility personnel should directly 
telephone the woman who has no health care provider if the result is 
suspicious for cancer (B).
    Many women believe that mammography results are normal if they 
are not contacted after their examination. This impression that ``no 
news is good news'' can have serious adverse consequences for women 
with an abnormal examination. The interpreting physician, the 
referring health care provider, and the woman are all responsible 
for ensuring that mammography results are communicated in an 
effective and timely manner and that recommendations are carried 
out. Timely communication is necessary whether results are normal or 
abnormal (Table 3).
    An increasing number of mammography facilities have begun to 
report both normal and abnormal results directly to the woman. This 
can be accomplished without disrupting the woman's relationship with 
her referring provider. Studies have shown that direct communication 
of results to the woman by the mammography facility produces a 
dramatic improvement in compliance with follow recommendations [R]. 
Traditional communication procedures, where the facility 
communicates only with the referring provider, result in inadequate 
compliance with follow up recommendations [R].
    Problems in communicating abnormal results have included 
confusion concerning the appropriate steps to be taken; 
inappropriate or insensitive communication, resulting in avoidable 
anxiety and confusion; delay in receipt of results; and failure to 
communicate results to the woman at all--for example, when reports 
are misfiled or filed unread. These problems have caused delays in 
diagnosis and treatment, with consequences that include limited 
treatment options and death [R]. Providing results directly to the 
woman is a sound risk-management procedure, reducing the prospect of 
medicolegal complications for both the interpreting physician and 
the referring health care provider [R].

                                                 Table 3.--Reporting of Results by Mammography Facility                                                 
--------------------------------------------------------------------------------------------------------------------------------------------------------
    Outcome of Mammography                                                                   Phone Communication to Health    Always Necessary Written  
       Examination and          Communication to Women--Oral  Communication to Women--Write   Care Provider in Addition to      Report to Health Care   
 Recommendation for Followup      (Onsite or by Telephone)       (Onsite or Sent by Mail)           Standard Report                   Provider          
--------------------------------------------------------------------------------------------------------------------------------------------------------
Normal                         Optional                       Strongly Recommended           None                           Strongly Recommended        
--------------------------------------------------------------------------------------------------------------------------------------------------------
Abnormal: schedule additional                                                                                                                           
 imaging and/or                Recommended\2\                 Strongly recommended\2\        Recommended\3\                 Strongly recommended        
 ultrasonography               Optional\2\                    Strongly recommended\2\        Recommended\3\                 Strongly recommended        
a) On line\1\                                                                                                                                           
b) Off line\1\                                                                                                                                          
Abnormal: short-interval       Optional                       Strongly recommended           Optional                       Strongly recommended        
 followup                                                                                                                                               
Abnormal: Biopsy               Optional strongly recommended  Strongly recommended\4\        Strongly recommended           Strongly recommended        
                                for self-referred women                                                                                                 
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ For an online study, the interpreting physician is present and reads the mammogram while the patient is there. For an offline study, the mammogram  
  may be read after the woman leaves so the interpreting physician does not have to be present.                                                         
\2\ For any patient for whom additional views or ultrasonography are recommended, a telephone call or discussion onsite with the patient may precede the
  written letter when the studies are to be performed immediately or within 2 days at that mammography facility. However, the results of the original   
  and additional studies must be provided to the woman in writing.                                                                                      
\3\ A telephone call from the mammography facility to the woman's designated physician or other health care provider is recommended. For self-referred  
  patients, the telephone call should be made to the woman herself.                                                                                     
\4\ For any patient without a direct referral, the mammography facility may wish to send the letter via registered or certified mail.                   
Note: Strong recommendations deal with elements of mammography that the panel considers essential to good practice. Recommendations deal with elements  
  of mammography that the panel considers attainable in most but not all cases. Options are statements of a less compelling nature that cannot be       
  justified as recommendations.                                                                                                                         

    Communicating normal results directly to the woman as soon as 
possible eliminates anxiety, reinforces the woman's role as a 
responsible participant in the process, reminds the woman of the 
importance of regular screening, and is a quality assurance 
safeguard. Effective communication is most crucial when results are 
abnormal and additional imaging or other follow up is required. If 
findings are abnormal, the written results should detail steps the 
woman should take next.
    Any written communication must have language that is carefully 
constructed to impart results without causing undue anxiety, to 
promote a relationship between the woman and a health care provider, 
and to encourage the woman to take the next step. [Note--the AHCPR 
publication provides several examples of letters for communicating 
results directly to women.]

[[Page 55976]]

    Mammography facilities may accept self-requesting and self-
referred women for mammography. Interpreting physicians have 
additional responsibilities for ensuring the effective communication 
of results for these women.
      Self-requesting woman. This woman comes for 
mammography on her own initiative but is able to name a personal 
physician or health care provider. Whether the woman is having 
screening or diagnostic mammography, the interpreting physician 
should document that the designated provider accepts responsibility 
for the woman's breast care before sending out the mammography 
report. In cases where the provider declines to accept the 
mammography report from the mammography facility, the facility 
should treat the woman as if she were self-referred.
      Self-referred woman. This is a woman who comes for 
mammography but has no personal health care provider or for whom the 
provider declines responsibility. Whether the woman is having 
screening or diagnostic mammography, the interpreting physician 
assumes responsibility for the woman's breast care, including 
education, physical examination, and communication of mammography 
results directly to the patient in understandable language. 
Mammography facility personnel should give the woman a list of 
qualified providers. If the woman chooses a provider from a list 
provided by the mammography facility, the interpreting physician 
should ensure that the chosen clinician will assume responsibility 
for the woman's breast care. Although self-referral has improved 
access to mammography, it has increased the responsibilities of the 
interpreting physician and created more possibilities for failure to 
communicate abnormal results.
    STRONG RECOMMENDATION: At the time of the examination, 
mammography facility personnel should inform all women of the time 
period in which they will receive their results and of the 
possibility that prior films may need to be obtained. The woman 
should also be instructed to call the mammography facility or her 
health care provider if she does not receive her results within the 
stated time period. The facility should report results to the 
woman's provider and to the woman within the shortest practical time 
period. (B)
    RECOMMENDATION: The facility should use its best efforts to send 
a report to the referring health care provider and to send results 
to the woman as soon as possible, usually within 10 business days. 
The reporting period should not exceed 30 days. (B)
    STRONG RECOMMENDATION: The interpreting physician or designee 
should telephone the results of an abnormal examination that 
requires needle or open biopsy to the referring (or designated) 
health care provider's office in a timely manner. (B)
    RECOMMENDATION: The interpreting physician or designee should 
telephone the results of an abnormal examination that requires 
additional views and/or ultrasonography in a timely manner to the 
referring (or designated) health care provider's office. (B)
    OPTIONAL: The interpreting physician or the referring (or 
designated) health care provider may telephone the woman directly to 
explain abnormal findings, their significance, and recommended next 
steps. (B)
    Mammography facility personnel should telephone the referring or 
designated health care provider because the written report may not 
reach the provider or may not arrive in time for the provider to 
respond to questions from the patient. A telephone call also enables 
the provider to ask questions about the report and to discuss follow 
up options with the interpreting physician [R].
    When mammography results are abnormal, a telephone call to the 
woman's designated health care provider before a report is sent may 
identify and resolve any vagueness in the provider-patient status. 
For a self-requesting woman with an abnormal finding, this call will 
significantly reduce the chance that she will slip through the 
cracks.
    If the woman does not have a provider or if the provider 
declines to accept the report, the interpreting physician or 
designee should call the woman directly to explain the result and 
the recommended next steps. This telephone communication is in 
addition to the written report and should offer the option to have 
the results explained in person. Information should not be left on 
an answering machine or given to another individual without the 
woman's express prior permission. Particularly for the woman without 
a referring provider, the mammography facility may choose to send 
written notification of abnormal results by certified mail or with 
return receipt requested. Mammography facility personnel should 
document the communication to the referring provider or the woman in 
the woman's medical record. Recommended reporting is outlined on 
Table 3.``
    Chapter 6 of the AHCPR document also provides more information 
on the communication responsibilities of the interpreting physician.

VII. References

    The following references have been placed on display in the Dockets 
Management Branch (address above) and may be seen by interested persons 
between 9 a.m. and 4 p.m., Monday through Friday.
    1. Ries, L. A. G., B. A. Miller, and B. F. Hankey, et al. 
(Eds.), ``SEER Cancer Statistics Review, 1973-1991,'' National 
Cancer Institute, NIH Pub. No. 94-2789, Bethesda, MD, 1994.
    2. AHCPR, ``Quality Determinants of Mammography,'' AHCPR Pub. 
No. 95-0632, October, 1994.
    3. U.S. GAO, ``Mammography Services Initial Impact of New 
Federal Law Has Been Positive,'' GAO/HEHS-96-17, October, 1995.
    4. Linver, M. N., J. R. Osuch, R. J. Brenner, and R. A. Smith, 
``The Mammography Audit: A Primer for the Mammography Quality 
Standards Act (MQSA),'' American Journal of Radiology, 1995; 165:19-
25.
    5. CDC, ``Use of Mammography Services by Women Aged  
65 Years Enrolled in Medicare--United States, 1995-1993,'' 1995; 
44:777-781.

List of Subjects

21 CFR Part 16

    Administrative practice and procedure.

21 CFR Part 900

    Electronic products, Health facilities, Mammography, Medical 
devices, Radiation protection, Reporting and recordkeeping 
requirements, X-rays.
    Therefore, under the Federal Food, Drug, and Cosmetic Act, and 
under authority delegated to the Commissioner of Food and Drugs, 21 CFR 
parts 16 and 900 are amended as follows:

PART 16--REGULATORY HEARINGS BEFORE THE FOOD AND DRUG 
ADMINISTRATION

    1. The authority citation for 21 CFR part 16 is revised to read as 
follows:

    Authority: 21 U.S.C. 41-40, 141-149, 321-394, 467f, 679, 821, 
1034; 42 U.S.C. 201-262, 263b, 364; 15 U.S.C. 1451-1461, 28 U.S.C. 
2112.

    2. Section 16.1 is amended in paragraph (b)(2) by numerically 
adding entries for Secs. 900.7 and 900.14 to read as follows:

Sec. 716.1  Scope.

* * * * *
    (b) * * *
    (2) Regulatory provisions:
* * * * *
    Sec. 900.7, relating to approval, reapproval, or withdrawal of 
approval of mammography accreditation bodies or rejection of a 
proposed fee for accreditation.
    Sec. 900.14, relating to suspension or revocation of a 
mammography certificate.
* * * * *
    3. 21 CFR Part 900 is revised to read as follows:

PART 900--MAMMOGRAPHY

Subpart A--Accreditation

Sec.
900.1  Scope.
900.2  Definitions.
900.3  Application for approval as an accreditation body.
900.4  Standards for accreditation bodies.
900.5  Evaluation.
900.6  Withdrawal of approval.
900.7  Hearings.
900.8-900.9  [Reserved]

Subpart B--Quality Standards and Certification

900.10  Applicability.
900.11  Requirements for certification.
900.12  Quality standards.
900.13  Revocation of accreditation and revocation of accreditation 
body approval.
900.14  Suspension or revocation of certificates.

[[Page 55977]]

900.15  Appeals of adverse accreditation or reaccreditation 
decisions that preclude certification or recertification.
900.16  Appeals of denials of certification.
900.17  [Reserved]
900.18  Alternative requirements for Sec. 900.12 quality standards.

    Authority: 21 U.S.C. 360i, 360nn, 374(e); 42 U.S.C. 263b.

Subpart A--Accreditation


Sec. 900.1  Scope.

    The regulations set forth in this part implement the Mammography 
Quality Standards Act (MQSA) (42 U.S.C. 263b). Subpart A of this part 
establishes procedures whereby an entity can apply to become a Food and 
Drug Administration (FDA)-approved accreditation body to accredit 
facilities to be eligible to perform screening or diagnostic 
mammography services. Subpart A further establishes requirements and 
standards for accreditation bodies to ensure that all mammography 
facilities under the jurisdiction of the United States are adequately 
and consistently evaluated for compliance with national quality 
standards for mammography. Subpart B of this part establishes minimum 
national quality standards for mammography facilities to ensure safe, 
reliable, and accurate mammography. The regulations set forth in this 
part do not apply to facilities of the Department of Veterans Affairs.


Sec. 900.2  Definitions.

    The following definitions apply to subparts A and B of this part:
    (a) Accreditation body or body means an entity that has been 
approved by FDA under Sec. 900.3(d) to accredit mammography facilities.
    (b) Action limits or action levels means the minimum and maximum 
values of a quality assurance measurement that can be interpreted as 
representing acceptable performance with respect to the parameter being 
tested. Values less than the minimum or greater than the maximum action 
limit or level indicate that corrective action must be taken by the 
facility. Action limits or levels are also sometimes called control 
limits or levels.
    (c) Adverse event means an undesirable experience associated with 
mammography activities within the scope of 42 U.S.C. 263b. Adverse 
events include but are not limited to:
    (1) Poor image quality;
    (2) Failure to send mammography reports within 30 days to the 
referring physician or in a timely manner to the self-referred patient; 
and
    (3) Use of personnel that do not meet the applicable requirements 
of Sec. 900.12(a).
    (d) Air kerma means kerma in a given mass of air. The unit used to 
measure the quantity of air kerma is the Gray (Gy). For X-rays with 
energies less than 300 kiloelectronvolts (keV), 1 Gy = 100 radian (rad) 
= 114 roentgens (R) of exposure.
    (e) Breast implant means a prosthetic device implanted in the 
breast.
    (f) Calendar quarter means any one of the following time periods 
during a given year: January 1 through March 31, April 1 through June 
30, July 1 through September 30, or October 1 through December 31.
    (g) Category I means medical educational activities that have been 
designated as Category I by the Accreditation Council for Continuing 
Medical Education (ACCME), the American Osteopathic Association (AOA), 
a state medical society, or an equivalent organization.
    (h) Certificate means the certificate described in Sec. 900.11(a).
    (i) Certification means the process of approval of a facility by 
FDA to provide mammography services.
    (j) Clinical image means a mammogram.
    (k) Consumer means an individual who chooses to comment or complain 
in reference to a mammography examination, including the patient or 
representative of the patient (e.g., family member or referring 
physician).
    (l) Continuing education unit or continuing education credit means 
one contact hour of training.
    (m) Contact hour means an hour of training received through direct 
instruction.
    (n) Direct instruction means:
    (1) Face-to-face interaction between instructor(s) and student(s), 
as when the instructor provides a lecture, conducts demonstrations, or 
reviews student performance; or
    (2) The administration and correction of student examinations by an 
instructor(s) with subsequent feedback to the student(s).
    (o) Direct supervision means that:
    (1) During joint interpretation of mammograms, the supervising 
interpreting physician reviews, discusses, and confirms the diagnosis 
of the physician being supervised and signs the resulting report before 
it is entered into the patient's records; or
    (2) During the performance of a mammography examination or survey 
of the facility's equipment and quality assurance program, the 
supervisor is present to observe and correct, as needed, the 
performance of the individual being supervised who is performing the 
examination or conducting the survey.
    (p) Established operating level means the value of a particular 
quality assurance parameter that has been established as an acceptable 
normal level by the facility's quality assurance program.
    (q) Facility means a hospital, outpatient department, clinic, 
radiology practice, mobile unit, office of a physician, or other 
facility that conducts mammography activities, including the following: 
Operation of equipment to produce a mammogram, processing of the 
mammogram, initial interpretation of the mammogram, and maintaining 
viewing conditions for that interpretation. This term does not include 
a facility of the Department of Veterans Affairs.
    (r) First allowable time means the earliest time a resident 
physician is eligible to take the diagnostic radiology boards from an 
FDA-designated certifying body. The ``first allowable time'' may vary 
with the certifying body.
    (s) FDA means the Food and Drug Administration.
    (t) Interim regulations means the regulations entitled 
``Requirements for Accrediting Bodies of Mammography Facilities'' (58 
FR 67558-67565) and ``Quality Standards and Certification Requirements 
for Mammography Facilities'' (58 FR 67565-67572), published by FDA on 
December 21, 1993, and amended on September 30, 1994 (59 FR 49808-
49813). These regulations established the standards that had to be met 
by mammography facilities in order to lawfully operate between October 
1, 1994, and April 28, 1999.
    (u) Interpreting physician means a licensed physician who 
interprets mammograms and who meets the requirements set forth in 
Sec. 900.12(a)(1).
    (v) Kerma means the sum of the initial energies of all the charged 
particles liberated by uncharged ionizing particles in a material of 
given mass.
    (w) Laterality means the designation of either the right or left 
breast.
    (x) Lead interpreting physician means the interpreting physician 
assigned the general responsibility for ensuring that a facility's 
quality assurance program meets all of the requirements of 
Sec. 900.12(d) through (f). The administrative title and other 
supervisory responsibilities of the individual, if any, are left to the 
discretion of the facility.
    (y) Mammogram means a radiographic image produced through 
mammography.

[[Page 55978]]

    (z) Mammographic Modality means a technology, within the scope of 
42 U.S.C. 263b, for radiography of the breast. Examples are screen-film 
mammography and xeromammography.
    (aa) Mammography means radiography of the breast, but, for the 
purposes of this part, does not include:
    (1) Radiography of the breast performed during invasive 
interventions for localization or biopsy procedures; or
    (2) Radiography of the breast performed with an investigational 
mammography device as part of a scientific study conducted in 
accordance with FDA's investigational device exemption regulations in 
part 812 of this chapter.
    (bb) Mammography equipment evaluation means an onsite assessment of 
mammography unit or image processor performance by a medical physicist 
for the purpose of making a preliminary determination as to whether the 
equipment meets all of the applicable standards in Sec. 900.12(b) and 
(e).
    (cc) Mammography medical outcomes audit means a systematic 
collection of mammography results and the comparison of those results 
with outcomes data.
    (dd) Mammography unit or units means an assemblage of components 
for the production of X-rays for use during mammography, including, at 
a minimum: An X-ray generator, an X-ray control, a tube housing 
assembly, a beam limiting device, and the supporting structures for 
these components.
    (ee) Mean optical density means the average of the optical 
densities measured using phantom thicknesses of 2, 4, and 6 centimeters 
with values of kilovolt peak (kVp) clinically appropriate for those 
thicknesses.
    (ff) Medical physicist means a person trained in evaluating the 
performance of mammography equipment and facility quality assurance 
programs and who meets the qualifications for a medical physicist set 
forth in Sec. 900.12(a)(3).
    (gg) MQSA means the Mammography Quality Standards Act.
    (hh) Multi-reading means two or more physicians, at least one of 
whom is an interpreting physician, interpreting the same mammogram.
    (ii) Patient means any individual who undergoes a mammography 
evaluation in a facility, regardless of whether the person is referred 
by a physician or is self-referred.
    (jj) Phantom means a test object used to simulate radiographic 
characteristics of compressed breast tissue and containing components 
that radiographically model aspects of breast disease and cancer.
    (kk) Phantom image means a radiographic image of a phantom.
    (ll) Physical science means physics, chemistry, radiation science 
(including medical physics and health physics), and engineering.
    (mm) Positive mammogram means a mammogram that has an overall 
assessment of findings that are either ``suspicious'' or ``highly 
suggestive of malignancy.''
    (nn) Provisional certificate means the provisional certificate 
described in Sec. 900.11(b)(2).
    (oo) Qualified instructor means an individual whose training and 
experience adequately prepares him or her to carry out specified 
training assignments. Interpreting physicians, radiologic 
technologists, or medical physicists who meet the requirements of 
Sec. 900.12(a) would be considered qualified instructors in their 
respective areas of mammography. Other examples of individuals who may 
be qualified instructors for the purpose of providing training to meet 
the regulations of this part include, but are not limited to, 
instructors in a post-high school training institution and 
manufacturer's representatives.
    (pp) Quality control technologist means an individual meeting the 
requirements of Sec. 900.12(a)(2) who is responsible for those quality 
assurance responsibilities not assigned to the lead interpreting 
physician or to the medical physicist.
    (qq) Radiographic equipment means X-ray equipment used for the 
production of static X-ray images.
    (rr) Radiologic technologist means an individual specifically 
trained in the use of radiographic equipment and the positioning of 
patients for radiographic examinations and who meets the requirements 
set forth in Sec. 900.12(a)(2).
    (ss) Serious adverse event means an adverse advent that may 
significantly compromise clinical outcomes, or an adverse event for 
which a facility fails to take appropriate corrective action in a 
timely manner.
    (tt) Serious complaint means a report of a serious adverse event.
    (uu) Standard breast means a 4.2 centimeter (cm) thick compressed 
breast consisting of 50 percent glandular and 50 percent adipose 
tissue.
    (vv) Survey means an onsite physics consultation and evaluation of 
a facility quality assurance program performed by a medical physicist.
    (ww) Time cycle means the film development time.
    (xx) Traceable to a national standard means an instrument is 
calibrated at either the National Institute of Standards and Technology 
(NIST) or at a calibration laboratory that participates in a 
proficiency program with NIST at least once every 2 years and the 
results of the proficiency test conducted within 24 months of 
calibration show agreement within  3 percent of the 
national standard in the mammography energy range.


Sec. 900.3  Application for approval as an accreditation body.

    (a) Eligibility. Private nonprofit organizations or State agencies 
capable of meeting the requirements of this subpart A may apply for 
approval as accreditation bodies.
    (b) Application for initial approval. (1) An applicant seeking 
initial FDA approval as an accreditation body shall inform the Division 
of Mammography Quality and Radiation Programs (DMQRP), Center for 
Devices and Radiology Health (HFZ-240), Food and Drug Administration, 
1350 Piccard Dr., Rockville, MD 20850, marked Attn: Mammography 
Standards Branch, of its desire to be approved as an accreditation body 
and of its requested scope of authority.
    (2) Following receipt of the request, FDA will provide the 
applicant with additional information to aid in submission of an 
application for approval as an accreditation body.
    (3) The applicant shall furnish to FDA, at the address in 
Sec. 900.3(b)(1), three copies of an application containing the 
following information, materials, and supporting documentation:
    (i) Name, address, and phone number of the applicant and, if the 
applicant is not a State agency, evidence of nonprofit status (i.e., of 
fulfilling Internal Revenue Service requirements as a nonprofit 
organization);
    (ii) Detailed description of the accreditation standards the 
applicant will require facilities to meet and a discussion 
substantiating their equivalence to FDA standards required under 
Sec. 900.12;
    (iii) Detailed description of the applicant's accreditation review 
and decisionmaking process, including:
    (A) Procedures for performing accreditation and reaccreditation 
clinical image review in accordance with Sec. 900.4(c), random clinical 
image reviews in accordance with Sec. 900.4(f), and additional 
mammography review in accordance with Sec. 900.12(j);
    (B) Procedures for performing phantom image review;
    (C) Procedures for assessing mammography equipment evaluations and 
surveys;

[[Page 55979]]

    (D) Procedures for initiating and performing onsite visits to 
facilities;
    (E) Procedures for assessing facility personnel qualifications;
    (F) Copies of the accreditation application forms, guidelines, 
instructions, and other materials the applicant will send to facilities 
during the accreditation process, including an accreditation history 
form that requires each facility to provide a complete history of prior 
accreditation activities and a statement that all information and data 
submitted in the application is true and accurate, and that no material 
fact has been omitted;
    (G) Policies and procedures for notifying facilities of 
deficiencies;
    (H) Procedures for monitoring corrections of deficiencies by 
facilities;
    (I) Policies and procedures for suspending or revoking a facility's 
accreditation;
    (J) Policies and procedures that will ensure processing of 
accreditation applications and renewals within a timeframe approved by 
FDA and assurances that the body will adhere to such policies and 
procedures; and
    (K) A description of the applicant's appeals process for facilities 
contesting adverse accreditation status decisions.
    (iv) Education, experience, and training requirements for the 
applicant's professional staff, including reviewers of clinical or 
phantom images;
    (v) Description of the applicant's electronic data management and 
analysis system with respect to accreditation review and decision 
processes and the applicant's ability to provide electronic data in a 
format compatible with FDA data systems;
    (vi) Resource analysis that demonstrates that the applicant's 
staffing, funding, and other resources are adequate to perform the 
required accreditation activities;
    (vii) Fee schedules with supporting cost data;
    (viii) Statement of policies and procedures established to avoid 
conflicts of interest or the appearance of conflicts of interest by the 
applicant's board members, commissioners, professional personnel 
(including reviewers of clinical and phantom images), consultants, 
administrative personnel, and other representatives of the applicant;
    (ix) Statement of policies and procedures established to protect 
confidential information the applicant will collect or receive in its 
role as an accreditation body;
    (x) Disclosure of any specific brand of imaging system or 
component, measuring device, software package, or other commercial 
product used in mammography that the applicant develops, sells, or 
distributes;
    (xi) Description of the applicant's consumer complaint mechanism;
    (xii) Satisfactory assurances that the applicant shall comply with 
the requirements of Sec. 900.4; and
    (xiii) Any other information as may be required by FDA.
    (c) Application for renewal of approval. An approved accreditation 
body that intends to continue to serve as an accreditation body beyond 
its current term shall apply to FDA for renewal or notify FDA of its 
plans not to apply for renewal in accordance with the following 
procedures and schedule:
    (1) At least 9 months before the date of expiration of a body's 
approval, the body shall inform FDA, at the address given in 
Sec. 900.3(b)(1), of its intent to seek renewal.
    (2) FDA will notify the applicant of the relevant information, 
materials, and supporting documentation required under Sec. 900.3(b)(3) 
that the applicant shall submit as part of the renewal procedure.
    (3) At least 6 months before the date of expiration of a body's 
approval, the applicant shall furnish to FDA, at the address in 
Sec. 900.3(b)(1), three copies of a renewal application containing the 
information, materials, and supporting documentation requested by FDA 
in accordance with Sec. 900.3(c)(2).
    (4) No later than July 28, 1998 any accreditation body approved 
under the interim regulations published in the Federal Register of 
December 21, 1993 (58 FR 67558), that desires to continue to serve as 
an accreditation body under the final regulations shall apply for 
renewal of approval in accordance with the procedures set forth in 
paragraphs (c)(1) through (c)(3) of this section.
    (5) Any accreditation body that does not plan to renew its approval 
shall so notify FDA at the address given in paragraph (b)(1) of this 
section at least 9 months before the expiration of the body's term of 
approval.
    (d) Rulings on applications for initial and renewed approval. (1) 
FDA will conduct a review and evaluation to determine whether the 
applicant substantially meets the applicable requirements of this 
subpart and whether the accreditation standards the applicant will 
require facilities to meet are substantially the same as the quality 
standards published under subpart B of this part.
    (2) FDA will notify the applicant of any deficiencies in the 
application and request that those deficiencies be rectified within a 
specified time period. If the deficiencies are not rectified to FDA's 
satisfaction within the specified time period, the application for 
approval as an accreditation body may be rejected.
    (3) FDA shall notify the applicant whether the application has been 
approved or denied. That notification shall list any conditions 
associated with approval or state the bases for any denial.
    (4) The review of any application may include a meeting between FDA 
and representatives of the applicant at a time and location mutually 
acceptable to FDA and the applicant.
    (5) FDA will advise the applicant of the circumstances under which 
a denied application may be resubmitted.
    (6) If FDA does not reach a final decision on a renewal application 
in accordance with this paragraph before the expiration of an 
accreditation body's current term of approval, the approval will be 
deemed extended until the agency reaches a final decision on the 
application, unless an accreditation body does not rectify deficiencies 
in the application within the specified time period, as required in 
paragraph (d)(2) of this section.
    (e) Relinquishment of authority. An accreditation body that decides 
to relinquish its accreditation authority before expiration of the 
body's term of approval shall submit a letter of such intent to FDA, at 
the address in Sec. 900.3(b)(1), at least 9 months before relinquishing 
such authority.
    (f) Transfer of records. An accreditation body that does not apply 
for renewal of accreditation body approval, is denied such approval by 
FDA, or relinquishes its accreditation authority and duties before 
expiration of its term of approval, shall:
    (1) Transfer facility records and other related information as 
required by FDA to a location and according to a schedule approved by 
FDA.
    (2) Notify, in a manner and time period approved by FDA, all 
facilities accredited or seeking accreditation by the body that the 
body will no longer have accreditation authority.
    (g) Scope of authority. An accreditation body's term of approval is 
for a period not to exceed 7 years. FDA may limit the scope of 
accreditation authority.


Sec. 900.4  Standards for accreditation bodies.

    (a) Code of conduct and general responsibilities. The accreditation 
body shall accept the following responsibilities in order to ensure 
safe and accurate mammography at the facilities it accredits and shall 
perform these responsibilities in a manner that ensures the integrity 
and impartiality of accreditation body actions.

[[Page 55980]]

    (1)(i) When an accreditation body receives or discovers information 
that suggests inadequate image quality, or upon request by FDA, the 
accreditation body shall review a facility's clinical images or other 
aspects of a facility's practice to assist FDA in determining whether 
or not the facility's practice poses a serious risk to human health. 
Such reviews are in addition to the evaluation an accreditation body 
performs as part of the initial accreditation or renewal process for 
facilities.
    (ii) If review by the accreditation body demonstrates that a 
problem does exist with respect to image quality or other aspects of a 
facility's compliance with quality standards, or upon request by FDA, 
the accreditation body shall require or monitor corrective actions, or 
suspend or revoke accreditation of the facility.
    (2) The accreditation body shall inform FDA as soon as possible but 
in no case longer than 2 business days after becoming aware of 
equipment or practices that pose a serious risk to human health.
    (3) The accreditation body shall establish and administer a quality 
assurance (QA) program that has been approved by FDA in accordance with 
Sec. 900.3(d) or paragraph (a)(8) of this section. Such quality 
assurance program shall:
    (i) Include requirements for clinical image review and phantom 
image review;
    (ii) Ensure that clinical and phantom images are evaluated 
consistently and accurately; and
    (iii) Specify the methods and frequency of training and evaluation 
for clinical and phantom image reviewers, and the bases and procedures 
for removal of such reviewers.
    (4) The accreditation body shall establish measures that FDA has 
approved in accordance with Sec. 900.3(d) or paragraph (a)(8) of this 
section to reduce the possibility of conflict of interest or facility 
bias on the part of individuals acting on the body's behalf. Such 
individuals who review clinical or phantom images under the provisions 
of paragraphs (c) and (d) of this section or who visit facilities under 
the provisions of paragraph (f) of this section shall not review 
clinical or phantom images from or visit a facility with which such 
individuals maintain a financial relationship, or when it would 
otherwise be a conflict of interest for them to do so, or when they 
have a bias in favor of or against the facility.
    (5) The accreditation body may require specific equipment 
performance or design characteristics that FDA has approved. However, 
no accreditation body shall require, either explicitly or implicitly, 
the use of any specific brand of imaging system or component, measuring 
device, software package, or other commercial product as a condition 
for accreditation by the body, unless FDA determines that it is in the 
best interest of public health to do so.
    (i) Any representation, actual or implied, either orally, in sales 
literature, or in any other form of representation, that the purchase 
or use of a particular product brand is required in order for any 
facility to be accredited or certified under Sec. 900.11(b), is 
prohibited, unless FDA approves such representation.
    (ii) Unless FDA has approved the exclusive use and promotion of a 
particular commercial product in accordance with this section, all 
products produced, distributed, or sold by an accreditation body or an 
organization that has a financial or other relationship with the 
accreditation body that may be a conflict of interest or have the 
appearance of a conflict of interest with the body's accreditation 
functions, shall bear a disclaimer stating that the purchase or use of 
such products is not required for accreditation or certification of any 
facility under Sec. 900.11(b). Any representations about such products 
shall include a similar disclaimer.
    (6) When an accreditation body denies accreditation to a facility, 
the accreditation body shall notify the facility in writing and explain 
the bases for its decision. The notification shall also describe the 
appeals process available from the accreditation body for the facility 
to contest the decision.
    (7) No accreditation body may establish requirements that preclude 
facilities from being accredited under Sec. 900.11(b) by any other 
accreditation body, or require accreditation by itself under MQSA if 
another accreditation body is available to a facility.
    (8) The accreditation body shall obtain FDA authorization for any 
changes it proposes to make in any standards that FDA has previously 
accepted under Sec. 900.3(d).
    (9) An accreditation body shall establish procedures to protect 
confidential information it collects or receives in its role as an 
accreditation body.
    (i) Nonpublic information collected from facilities for the purpose 
of carrying out accreditation body responsibilities shall not be used 
for any other purpose or disclosed, other than to FDA or its duly 
designated representatives, including State agencies, without the 
consent of the facility;
    (ii) Nonpublic information that FDA or its duly designated 
representatives, including State agencies, share with the accreditation 
body concerning a facility that is accredited or undergoing 
accreditation by that body shall not be further disclosed except with 
the written permission of FDA.
    (b) Monitoring facility compliance with quality standards. (1) The 
accreditation body shall require that each facility it accredits meet 
standards for the performance of quality mammography that are 
substantially the same as those in this subpart and in subpart B of 
this part.
    (2) The accreditation body shall notify a facility regarding 
equipment, personnel, and other aspects of the facility's practice that 
do not meet such standards and advise the facility that such equipment, 
personnel, or other aspects of the practice should not be used by the 
facility for activities within the scope of part 900.
    (3) The accreditation body shall specify the actions that 
facilities shall take to correct deficiencies in equipment, personnel, 
and other aspects of the practice to ensure facility compliance with 
applicable standards.
    (4) If deficiencies cannot be corrected to ensure compliance with 
standards or if a facility is unwilling to take corrective actions, the 
accreditation body shall immediately so notify FDA, and shall suspend 
or revoke the facility's accreditation in accordance with the policies 
and procedures described under Sec. 900.3(b)(3)(iii)(I).
    (c) Clinical image review for accreditation and reaccreditation.  
(1) Frequency of review. The accreditation body shall review clinical 
images from each facility accredited by the body at least once every 3 
years.
    (2) Requirements for clinical image attributes. The accreditation 
body shall use the following attributes for all clinical image reviews, 
unless FDA has approved other attributes:
    (i) Positioning. Sufficient breast tissue shall be imaged to ensure 
that cancers are not likely to be missed because of inadequate 
positioning.
    (ii) Compression. Compression shall be applied in a manner that 
minimizes the potential obscuring effect of overlying breast tissue and 
motion artifact.
    (iii) Exposure level. Exposure level shall be adequate to visualize 
breast structures. Images shall be neither underexposed nor 
overexposed.
    (iv) Contrast. Image contrast shall permit differentiation of 
subtle tissue density differences.

[[Page 55981]]

    (v) Sharpness. Margins of normal breast structures shall be 
distinct and not blurred.
    (vi) Noise. Noise in the image shall not obscure breast structures 
or suggest the appearance of structures not actually present.
    (vii) Artifacts. Artifacts due to lint, processing, scratches, and 
other factors external to the breast shall not obscure breast 
structures or suggest the appearance of structures not actually 
present.
    (viii) Examination identification. Each image shall have the 
following information indicated on it in a permanent, legible, and 
unambiguous manner and placed so as not to obscure anatomic structures:
    (A) Name of the patient and an additional patient identifier.
    (B) Date of examination.
    (C) View and laterality. This information shall be placed on the 
image in a position near the axilla. Standardized codes specified by 
the accreditation body and approved by FDA in accordance with 
Sec. 900.3(d) or paragraph (a)(8) of this section shall be used to 
identify view and laterality.
    (D) Facility name and location. At a minimum, the location shall 
include the city, State, and zip code of the facility.
    (E) Technologist identification.
    (F) Cassette/screen identification.
    (G) Mammography unit identification, if there is more than one unit 
in the facility.
    (3) Scoring of clinical images. Accreditation bodies shall 
establish and administer a system for scoring clinical images using all 
attributes specified in paragraphs (c)(2)(i) through (c)(2)(viii) of 
this section or an alternative system that FDA has approved in 
accordance with Sec. 900.3(d) or paragraph (a)(8) of this section. The 
scoring system shall include an evaluation for each attribute.
    (i) The accreditation body shall establish and employ criteria for 
acceptable and nonacceptable results for each of the 8 attributes as 
well as an overall pass-fail system for clinical image review that has 
been approved by FDA in accordance with Sec. 900.3(d) or paragraph 
(a)(8) of this section.
    (ii) All clinical images submitted by a facility to the 
accreditation body shall be reviewed independently by two or more 
clinical image reviewers.
    (4) Selection of clinical images for review. Unless otherwise 
specified by FDA, the accreditation body shall require that for each 
mammography unit in the facility:
    (i) The facility shall submit craniocaudal (CC) and mediolateral 
oblique (MLO) views from two mammographic examinations that the 
facility produced during a time period specified by the accreditation 
body;
    (ii) Clinical images submitted from one such mammographic 
examination for each unit shall be of dense breasts (predominance of 
glandular tissue) and the other shall be of fat-replaced breasts 
(predominance of adipose tissue);
    (iii) All clinical images submitted shall be images that the 
facility's interpreting physician(s) interpreted as negative or benign.
    (iv) If the facility has no clinical images meeting the 
requirements in paragraphs (c)(4)(i) through (c)(4)(iii) of this 
section, it shall so notify the accreditation body, which shall specify 
alternative clinical image selection methods that do not compromise 
care of the patient.
    (5) Clinical image reviewers. Accreditation bodies shall ensure 
that all of their clinical image reviewers:
    (i) Meet the interpreting physician requirements specified in 
Sec. 900.12(a)(1);
    (ii) Are trained and evaluated in the clinical image review 
process, for the types of clinical images to be evaluated by a clinical 
image reviewer, by the accreditation body before designation as 
clinical image reviewers and periodically thereafter; and
    (iii) Clearly document their findings and reasons for assigning a 
particular score to any clinical image and provide information to the 
facility for use in improving the attributes for which significant 
deficiencies were identified.
    (6) Image management. The accreditation body's QA program shall 
include a tracking system to ensure the security and return to the 
facility of all clinical images received and to ensure completion of 
all clinical image reviews by the body in a timely manner. The 
accreditation body shall return all clinical images to the facility 
within 60 days of their receipt by the body, with the following 
exceptions:
    (i) If the clinical images are needed earlier by the facility for 
clinical purposes, the accreditation body shall cooperate with the 
facility to accommodate such needs.
    (ii) If a clinical image reviewer identifies a suspicious 
abnormality on an image submitted for clinical image review, the 
accreditation body shall ensure that this information is provided to 
the facility and that the clinical images are returned to the facility. 
Both shall occur no later than 10 business days after identification of 
the suspected abnormality.
    (7) Notification of unsatisfactory image quality. If the 
accreditation body determines that the clinical images received from a 
facility are of unsatisfactory quality, the body shall notify the 
facility of the nature of the problem and its possible causes.
    (d) Phantom image review for accreditation and reaccreditation.  
(1) Frequency of review. The accreditation body shall review phantom 
images from each facility accredited by the body at least once every 3 
years.
    (2) Requirements for the phantom used. The accreditation body shall 
require that each facility submit for review phantom images that the 
facility produced using a phantom and methods of use specified by the 
body and approved by FDA in accordance with Sec. 900.3(d) or paragraph 
(a)(8) of this section.
    (3) Scoring phantom images. The accreditation body shall use a 
system for scoring phantom images that has been approved by FDA in 
accordance with Sec. 900.3(b) and (d) or paragraph (a)(8) of this 
section.
    (4) Phantom images selected for review. For each mammography unit 
in the facility, the accreditation body shall require the facility to 
submit phantom images that the facility produced during a time period 
specified by the body.
    (5) Phantom image reviewers. Accreditation bodies shall ensure that 
all of their phantom image reviewers:
    (i) Meet the requirements specified in Sec. 900.12(a)(3) or 
alternative requirements established by the accreditation body and 
approved by FDA in accordance with Sec. 900.3 or paragraph (a)(8) of 
this section;
    (ii) Are trained and evaluated in the phantom image review process, 
for the types of phantom images to be evaluated by a phantom image 
reviewer, by the accreditation body before designation as phantom image 
reviewers and periodically thereafter; and
    (iii) Clearly document their findings and reasons for assigning a 
particular score to any phantom image and provide information to the 
facility for use in improving its phantom image quality with regard to 
the significant deficiencies identified.
    (6) Image management. The accreditation body's QA program shall 
include a tracking system to ensure the security of all phantom images 
received and to ensure completion of all phantom image reviews by the 
body in a timely manner. All phantom images that result in a failure of 
accreditation shall be returned to the facility.
    (7) Notification measures for unsatisfactory image quality. If the 
accreditation body determines that the phantom images received from a 
facility are of unsatisfactory quality, the body shall notify the 
facility of the nature of the problem and its possible causes.

[[Page 55982]]

    (e) Reports of mammography equipment evaluation, surveys, and 
quality control. The following requirements apply to all facility 
equipment covered by the provisions of subparts A and B:
    (1) The accreditation body shall require every facility applying 
for accreditation to submit:
    (i) With its initial accreditation application, a mammography 
equipment evaluation that was performed by a medical physicist no 
earlier than 6 months before the date of application for accreditation 
by the facility. Such evaluation shall demonstrate compliance of the 
facility's equipment with the requirements in Sec. 900.12(e).
    (ii) Prior to accreditation, a survey that was performed no earlier 
than 6 months before the date of application for accreditation by the 
facility. Such survey shall assess the facility's compliance with the 
facility standards referenced in paragraph (b) of this section.
    (2) The accreditation body shall require that all facilities 
undergo an annual survey to ensure continued compliance with the 
standards referenced in paragraph (b) of this section and to provide 
continued oversight of facilities' quality control programs as they 
relate to such standards. The accreditation body shall require for all 
facilities that:
    (i) Such surveys be conducted annually;
    (ii) Facilities take reasonable steps to ensure that they receive 
reports of such surveys within 30 days of survey completion; and
    (iii) Facilities submit the results of such surveys and any other 
information that the body may require to the body at least annually.
    (3) The accreditation body shall review and analyze the information 
required in this section and use it to identify necessary corrective 
measures for facilities and to determine whether facilities should 
remain accredited by the body.
    (f) Accreditation Body Onsite Visits and Random Clinical Image 
Reviews. The accreditation body shall conduct onsite visits and random 
clinical image reviews of a sample of facilities to monitor and assess 
their compliance with standards established by the body for 
accreditation. The accreditation body shall submit annually to FDA, at 
the address given in Sec. 900.3(b)(1), 3 copies of a summary report 
describing all facility assessments the body conducted under the 
provisions of this section for the year being reported.
    (1) Onsite visits. (i) Sample size. Annually, each accreditation 
body shall visit at least 5 percent of the facilities it accredits. 
However, a minimum of 5 facilities shall be visited, and visits to no 
more than 50 facilities are required, unless problems identified in 
paragraph (f)(1)(i)(B) of this section indicate a need to visit more 
than 50 facilities.
    (A) At least 50 percent of the facilities visited shall be selected 
randomly.
    (B) Other facilities visited shall be selected based on problems 
identified through State or FDA inspections, serious complaints 
received from consumers or others, a previous history of noncompliance, 
or any other information in the possession of the accreditation body, 
inspectors, or FDA.
    (C) Before, during, or after any facility visit, the accreditation 
body may require that the facility submit to the body for review 
clinical images, phantom images, or any other information relevant to 
applicable standards in this subpart and in subpart B of this part.
    (ii) Visit plan. The accreditation body shall conduct facility 
onsite visits according to a visit plan that has been approved by FDA 
in accordance with Sec. 900.3(d) or paragraph (a)(8) of this section, 
unless otherwise directed by FDA in particular circumstances. At a 
minimum, such a plan shall provide for:
    (A) Assessment of overall clinical image QA activities of the 
facility;
    (B) Review of facility documentation to determine if appropriate 
mammography reports are sent to patients and physicians as required;
    (C) Selection of a sample of clinical images for clinical image 
review by the accreditation body. Clinical images shall be selected in 
a manner specified by the accreditation body and approved by FDA that 
does not compromise care of the patient as a result of the absence of 
the selected images from the facility;
    (D) Verification that the facility has a medical audit system in 
place and is correlating films and pathology reports for positive 
cases;
    (E) Verification that personnel specified by the facility are the 
ones actually performing designated personnel functions;
    (F) Verification that equipment specified by the facility is the 
equipment that is actually being used to perform designated equipment 
functions;
    (G) Verification that a consumer complaint mechanism is in place 
and that the facility is following its procedures; and
    (H) Review of all factors related to previously identified concerns 
or concerns identified during that visit.
    (2) Clinical image review for random sample of facilities. (i) 
Sample size. In addition to conducting clinical image reviews for 
accreditation and reaccreditation for all facilities, the accreditation 
body shall conduct clinical image reviews annually for a randomly 
selected sample as specified by FDA, but to include at least 3 percent 
of the facilities the body accredits. Accreditation bodies may count 
toward this random sample requirement all facilities selected randomly 
for the onsite visits described in paragraph (f)(1)(i)(A) of this 
section. Accreditation bodies shall not count toward the random sample 
requirement any facilities described in paragraph (f)(1)(i)(B) of this 
section that were selected for a visit because of previously identified 
concerns.
    (ii) Random clinical image review. In performing clinical image 
reviews of the random sample of facilities, accreditation bodies shall 
evaluate the same attributes as those in paragraph (c) of this section 
for review of clinical images for accreditation and reaccreditation.
    (iii) Accreditation bodies should not schedule random clinical 
image reviews at facilities that have received notification of the need 
to begin the accreditation renewal process or that have completed the 
accreditation renewal process within the previous 6 months.
    (iv) Selection of the random sample of clinical images for clinical 
image review by the accreditation body. Clinical images shall be 
selected in a manner, specified by the accreditation body and approved 
by FDA under Sec. 900.3(d) or paragraph (a)(8) of this section, that 
does not compromise care of the patient as a result of the absence of 
the selected images from the facility.
    (g) Consumer complaint mechanism. The accreditation body shall 
develop and administer a written and documented system, including 
timeframes, for collecting and resolving serious consumer complaints 
that could not be resolved at a facility. Such system shall have been 
approved by FDA in accordance withSec. 900.3(d) or paragraph (a)(8) of 
this section. Accordingly, all accreditation bodies shall:
    (1) Provide a mechanism for all facilities it accredits to file 
serious unresolved complaints with the accreditation body;
    (2) Maintain a record of every serious unresolved complaint 
received by the body on all facilities it accredits for a period of at 
least 3 years from the date of receipt of each such complaint;
    (h) Reporting and recordkeeping. All reports to FDA specified in 
paragraphs (h)(1) through (h)(4) of this section shall be prepared and 
submitted in a format

[[Page 55983]]

and medium prescribed by FDA and shall be submitted to a location and 
according to a schedule specified by FDA. The accreditation body shall:
    (1) Collect and submit to FDA the information required by 42 U.S.C. 
263b(d) for each facility when the facility is initially accredited and 
at least annually when updated, in a manner and at a time specified by 
FDA.
    (2) Accept applications containing the information required in 42 
U.S.C. 263b(c)(2) for provisional certificates and in Sec. 900.11(b)(3) 
for extension of provisional certificates, on behalf of FDA, and notify 
FDA of the receipt of such information;
    (3) Submit to FDA the name, identifying information, and other 
information relevant to 42 U.S.C. 263b and specified by FDA for any 
facility for which the accreditation body denies, suspends, or revokes 
accreditation, and the reason(s) for such action;
    (4) Submit to FDA an annual report summarizing all serious 
complaints received during the previous calendar year, their resolution 
status, and any actions taken in response to them;
    (5) Provide to FDA other information relevant to 42 U.S.C. 263b and 
required by FDA about any facility accredited or undergoing 
accreditation by the body.
    (i) Fees. Fees charged to facilities for accreditation shall be 
reasonable. Costs of accreditation body activities that are not related 
to accreditation functions under 42 U.S.C. 263b are not recoverable 
through fees established for accreditation.
    (1) The accreditation body shall make public its fee structure, 
including those factors, if any, contributing to variations in fees for 
different facilities.
    (2) At FDA's request, accreditation bodies shall provide financial 
records or other material to assist FDA in assessing the reasonableness 
of accreditation body fees. Such material shall be provided to FDA in a 
manner and time period specified by the agency.


Sec. 900.5  Evaluation.

    FDA shall evaluate annually the performance of each accreditation 
body. Such evaluation shall include an assessment of the reports of FDA 
or State inspections of facilities accredited by the body as well as 
any additional information deemed relevant by FDA that has been 
provided by the accreditation body or other sources or has been 
required by FDA as part of its oversight initiatives. The evaluation 
shall include a determination of whether there are major deficiencies 
in the accreditation body's performance that, if not corrected, would 
warrant withdrawal of the approval of the accreditation body under the 
provisions of Sec. 900.6.


Sec. 900.6  Withdrawal of approval.

    If FDA determines, through the evaluation activities of Sec. 900.5, 
or through other means, that an accreditation body is not in 
substantial compliance with this subpart, FDA may initiate the 
following actions:
    (a) Major deficiencies. If FDA determines that an accreditation 
body has failed to perform a major accreditation function 
satisfactorily, has demonstrated willful disregard for public health, 
has violated the code of conduct, has committed fraud, or has submitted 
material false statements to the agency, FDA may withdraw its approval 
of that accreditation body.
    (1) FDA shall notify the accreditation body of the agency's action 
and the grounds on which the approval was withdrawn.
    (2) An accreditation body that has lost its approval shall notify 
facilities accredited or seeking accreditation by it that its approval 
has been withdrawn. Such notification shall be made within a time 
period and in a manner approved by FDA.
    (b) Minor deficiencies. If FDA determines that an accreditation 
body has demonstrated deficiencies in performing accreditation 
functions and responsibilities that are less serious or more limited 
than the deficiencies in paragraph (a) of this section, FDA shall 
notify the body that it has a specified period of time to take 
particular corrective measures directed by FDA or to submit to FDA for 
approval the body's own plan of corrective action addressing the minor 
deficiencies. FDA may place the body on probationary status for a 
period of time determined by FDA, or may withdraw approval of the body 
as an accreditation body if corrective action is not taken.
    (1) If FDA places an accreditation body on probationary status, the 
body shall notify all facilities accredited or seeking accreditation by 
it of its probationary status within a time period and in a manner 
approved by FDA.
    (2) Probationary status shall remain in effect until such time as 
the body can demonstrate to the satisfaction of FDA that it has 
successfully implemented or is implementing the corrective action plan 
within the established schedule, and that the corrective actions have 
substantially eliminated all identified problems.
    (3) If FDA determines that an accreditation body that has been 
placed on probationary status is not implementing corrective actions 
satisfactorily or within the established schedule, FDA may withdraw 
approval of the accreditation body. The accreditation body shall notify 
all facilities accredited or seeking accreditation by it of its loss of 
FDA approval, within a time period and in a manner approved by FDA.
    (c) Reapplication by accreditation bodies that have had their 
approval withdrawn. (1) A former accreditation body that has had its 
approval withdrawn may submit a new application for approval if the 
body can provide information to FDA to establish that the problems that 
were grounds for withdrawal of approval have been resolved.
    (2) If FDA determines that the new application demonstrates that 
the body satisfactorily has addressed the causes of its previous 
unacceptable performance, FDA may reinstate approval of the 
accreditation body.
    (3) FDA may request additional information or establish additional 
conditions that must be met by a former accreditation body before FDA 
approves the reapplication.
    (4) FDA may refuse to accept an application from a former 
accreditation body whose approval was withdrawn because of fraud or 
willful disregard of public health.


Sec. 900.7  Hearings.

    (a) Opportunities to challenge final adverse actions taken by FDA 
regarding approval or reapproval of accreditation bodies, withdrawal of 
approval of accreditation bodies, or rejection of a proposed fee for 
accreditation shall be communicated through notices of opportunity for 
informal hearings in accordance with part 16 of this chapter.
    (b) A facility that has been denied accreditation is entitled to an 
appeals process from the accreditation body. The appeals process shall 
be specified in writing by the accreditation body and shall have been 
approved by FDA in accordance with Sec. 900.3(d) or Sec. 900.4(a)(8).
    (c) A facility that cannot achieve satisfactory resolution of an 
adverse accreditation decision through the accreditation body's appeals 
process may appeal to FDA for reconsideration in accordance with 
Sec. 900.15.
Secs. 900.8-900.9 [Reserved]

Subpart B--Quality Standards and Certification


Sec. 900.10  Applicability.

    The provisions of subpart B are applicable to all facilities under 
the regulatory jurisdiction of the United States that provide 
mammography

[[Page 55984]]

services, with the exception of the Department of Veterans Affairs.


Sec. 900.11  Requirements for certification.

    (a) General. After October 1, 1994, a certificate issued by FDA is 
required for lawful operation of all mammography facilities subject to 
the provisions of this subpart. To obtain a certificate from FDA, 
facilities are required to meet the quality standards in Sec. 900.12 
and to be accredited by an approved accreditation body or other entity 
as designated by FDA.
    (b) Application. (1) Certificates. (i) In order to qualify for a 
certificate, a facility must apply to an FDA-approved accreditation 
body, or to another entity designated by FDA. The facility shall submit 
to such body or entity the information required in 42 U.S.C. 
263b(d)(1).
    (ii) Following the agency's receipt of the accreditation body's 
decision to accredit a facility, or an equivalent decision by another 
entity designated by FDA, the agency may issue a certificate to the 
facility, or renew an existing certificate, if the agency determines 
that the facility has satisfied the requirements for certification or 
recertification.
    (2) Provisional certificates.  (i) A new facility beginning 
operation after October 1, 1994, is eligible to apply for a provisional 
certificate. The provisional certificate will enable the facility to 
perform mammography and to obtain the clinical images needed to 
complete the accreditation process. To apply for and receive a 
provisional certificate, a facility must meet the requirements of 42 
U.S.C. 263b(c)(2) and submit the necessary information to an approved 
accreditation body or other entity designated by FDA.
    (ii) Following the agency's receipt of the accreditation body's 
decision that a facility has submitted the required information, FDA 
may issue a provisional certificate to a facility upon determination 
that the facility has satisfied the requirements of 
Sec. 900.11(b)(2)(i). A provisional certificate shall be effective for 
up to 6 months from the date of issuance. A provisional certificate 
cannot be renewed, but a facility may apply for a 90-day extension of 
the provisional certificate.
    (3) Extension of provisional certificate.  (i) To apply for a 90-
day extension to a provisional certificate, a facility shall submit to 
its accreditation body, or other entity designated by FDA, a statement 
of what the facility is doing to obtain certification and evidence that 
there would be a significant adverse impact on access to mammography in 
the geographic area served if such facility did not obtain an 
extension.
    (ii) The accreditation body shall forward the request, with its 
recommendation, to FDA within 2 business days after receipt.
    (iii) FDA may issue a 90-day extension for a provisional 
certificate upon determination that the extension meets the criteria 
set forth in 42 U.S.C. 263b(c)(2).
    (iv) There can be no renewal of a provisional certificate beyond 
the 90-day extension.
    (c) Reinstatement policy. A previously certified facility that has 
allowed its certificate to expire, that has been refused a renewal of 
its certificate by FDA, or that has had its certificate suspended or 
revoked by FDA, may apply to have the certificate reinstated so that 
the facility may be considered to be a new facility and thereby be 
eligible for a provisional certificate.
    (1) Unless prohibited from reinstatement under Sec. 900.11(c)(4), a 
facility applying for reinstatement shall:
    (i) Contact an FDA-approved accreditation body or other entity 
designated by FDA to determine the requirements for reapplication for 
accreditation;
    (ii) Fully document its history as a previously provisionally 
certified or certified mammography facility, including the following 
information:
    (A) Name and address of the facility under which it was previously 
provisionally certified or certified;
    (B) Name of previous owner/lessor;
    (C) FDA facility identification number assigned to the facility 
under its previous certification; and
    (D) Expiration date of the most recent FDA provisional certificate 
or certificate; and
    (iii) Justify application for reinstatement of accreditation by 
submitting to the accreditation body or other entity designated by FDA, 
a corrective action plan that details how the facility has corrected 
deficiencies that contributed to the lapse of, denial of renewal, or 
revocation of its certificate.
    (2) FDA may issue a provisional certificate to the facility if:
    (i) The accreditation body or other entity designated by FDA 
notifies the agency that the facility has adequately corrected, or is 
in the process of correcting, pertinent deficiencies; and
    (ii) FDA determines that the facility has taken sufficient 
corrective action since the lapse of, denial of renewal, or revocation 
of its previous certificate.
    (3) After receiving the provisional certificate, the facility may 
lawfully resume performing mammography services while completing the 
requirements for certification.
    (4) If a facility's certificate was revoked on the basis of an act 
described in 41 U.S.C. 263b(i)(1), no person who owned or operated that 
facility at the time the act occurred may own or operate a mammography 
facility within 2 years of the date of revocation.


Sec. 900.12  Quality standards.

    (a) Personnel. The following requirements apply to all personnel 
involved in any aspect of mammography, including the production, 
processing, and interpretation of mammograms and related quality 
assurance activities:
    (1) Interpreting physicians. All physicians interpreting mammograms 
shall meet the following qualifications:
    (i) Initial qualifications. Unless the exemption in paragraph 
(a)(1)(iii)(A) of this section applies, before beginning to interpret 
mammograms independently, the interpreting physician shall:
    (A) Be licensed to practice medicine in a State;
    (B)(1) Be certified in an appropriate specialty area by a body 
determined by FDA to have procedures and requirements adequate to 
ensure that physicians certified by the body are competent to interpret 
radiological procedures, including mammography; or
    (2) Have had at least 3 months of documented formal training in the 
interpretation of mammograms and in topics related to mammography. The 
training shall include instruction in radiation physics, including 
radiation physics specific to mammography, radiation effects, and 
radiation protection. The mammographic interpretation component shall 
be under the direct supervision of a physician who meets the 
requirements of paragraph (a)(1) of this section;
    (C) Have a minimum of 60 hours of documented medical education in 
mammography, which shall include: Instruction in the interpretation of 
mammograms and education in basic breast anatomy, pathology, 
physiology, technical aspects of mammography, and quality assurance and 
quality control in mammography. All 60 of these hours shall be category 
I and at least 15 of the category I hours shall have been acquired 
within the 3 years immediately prior to the date that the physician 
qualifies as an interpreting physician. Hours spent in residency 
specifically devoted to mammography will be considered as equivalent to 
Category I continuing medical education credits and will be accepted if 
documented in writing by the appropriate

[[Page 55985]]

representative of the training institution; and
    (D) Unless the exemption in paragraph (a)(1)(iii)(B) of this 
section applies, have interpreted or multi-read at least 240 
mammographic examinations within the 6-month period immediately prior 
to the date that the physician qualifies as an interpreting physician. 
This interpretation or multi-reading shall be under the direct 
supervision of an interpreting physician.
    (ii) Continuing experience and education. All interpreting 
physicians shall maintain their qualifications by meeting the following 
requirements:
    (A) Following the second anniversary date of the end of the 
calendar quarter in which the requirements of paragraph (a)(1)(i) of 
this section were completed, the interpreting physician shall have 
interpreted or multi-read at least 960 mammographic examinations during 
the 24 months immediately preceding the date of the facility's annual 
MQSA inspection or the last day of the calendar quarter preceding the 
inspection or any date in-between the two. The facility will choose one 
of these dates to determine the 24-month period.
    (B) Following the third anniversary date of the end of the calendar 
quarter in which the requirements of paragraph (a)(1)(i) of this 
section were completed, the interpreting physician shall have taught or 
completed at least 15 category I continuing medical education units in 
mammography during the 36 months immediately preceding the date of the 
facility's annual MQSA inspection or the last day of the calendar 
quarter preceding the inspection or any date in between the two. The 
facility will choose one of these dates to determine the 36-month 
period. This training shall include at least six category I continuing 
medical education credits in each mammographic modality used by the 
interpreting physician in his or her practice; and
    (C) Before an interpreting physician may begin independently 
interpreting mammograms produced by a new mammographic modality, that 
is, a mammographic modality in which the physician has not previously 
been trained, the interpreting physician shall have at least 8 hours of 
training in the new mammographic modality.
    (D) Units earned through teaching a specific course can be counted 
only once towards the 15 required by paragraph (a)(1)(ii)(B) of this 
section, even if the course is taught multiple times during the 
previous 36 months.
    (iii) Exemptions. (A) Those physicians who qualified as 
interpreting physicians under paragraph (a)(1) of this section of FDA's 
interim regulations prior to April 28, 1999 are considered to have met 
the initial requirements of paragraph (a)(1)(i) of this section. They 
may continue to interpret mammograms provided they continue to meet the 
licensure requirement of paragraph (a)(1)(i)(A) of this section and the 
continuing experience and education requirements of paragraph 
(a)(1)(ii) of this section.
    (B) Physicians who have interpreted or multi-read at least 240 
mammographic examinations under the direct supervision of an 
interpreting physician in any 6-month period during the last 2 years of 
a diagnostic radiology residency and who become appropriately board 
certified at the first allowable time, as defined by an eligible 
certifying body, are otherwise exempt from paragraph (a)(1)(i)(D) of 
this section.
    (iv) Reestablishing qualifications. Interpreting physicians who 
fail to maintain the required continuing experience or continuing 
education requirements shall reestablish their qualifications before 
resuming the independent interpretation of mammograms, as follows:
    (A) Interpreting physicians who fail to meet the continuing 
experience requirements of paragraph (a)(1)(ii)(A) of this section 
shall:
    (1) Interpret or multi-read at least 240 mammographic examinations 
under the direct supervision of an interpreting physician, or
    (2) Interpret or multi-read a sufficient number of mammographic 
examinations, under the direct supervision of an interpreting 
physician, to bring the physician's total up to 960 examinations for 
the prior 24 months, whichever is less.
    (3) The interpretations required under paragraph (a)(1)(iv)(A)(1) 
or (a)(1)(iv)(A)(2) of this section shall be done within the 6 months 
immediately prior to resuming independent interpretation.
    (B) Interpreting physicians who fail to meet the continuing 
education requirements of paragraph (a)(1)(ii)(B) of this section shall 
obtain a sufficient number of additional category I continuing medical 
education credits in mammography to bring their total up to the 
required 15 credits in the previous 36 months before resuming 
independent interpretation.
    (2) Radiologic technologists. All mammographic examinations shall 
be performed by radiologic technologists who meet the following general 
requirements, mammography requirements, and continuing education and 
experience requirements:
    (i) General requirements. (A) Be licensed to perform general 
radiographic procedures in a State; or
    (B) Have general certification from one of the bodies determined by 
FDA to have procedures and requirements adequate to ensure that 
radiologic technologists certified by the body are competent to perform 
radiologic examinations; and
    (ii) Mammography requirements. Have, prior to April 28, 1999 
qualified as a radiologic technologist under paragraph (a)(2) of this 
section or completed at least 40 contact hours of documented training 
specific to mammography under the supervision of a qualified 
instructor. The hours of documented training shall include, but not 
necessarily be limited to:
    (A) Training in breast anatomy and physiology, positioning and 
compression, quality assurance/quality control techniques, imaging of 
patients with breast implants;
    (B) The performance of a minimum of 25 examinations under the 
direct supervision of an individual qualified under paragraph (a)(2) of 
this section; and
    (C) At least 8 hours of training in each mammography modality to be 
used by the technologist in performing mammography exams; and
    (iii) Continuing education requirements. (A) Following the third 
anniversary date of the end of the calendar quarter in which the 
requirements of paragraphs (a)(2)(i) and (a)(2)(ii) of this section 
were completed, the radiologic technologist shall have taught or 
completed at least 15 continuing education units in mammography during 
the 36 months immediately preceding the date of the facility's annual 
MQSA inspection or the last day of the calendar quarter preceding the 
inspection or any date in between the two. The facility will choose one 
of these dates to determine the 36-month period.
    (B) Units earned through teaching a specific course can be counted 
only once towards the 15 required in paragraph (a)(2)(iii)(A) of this 
section, even if the course is taught multiple times during the 
previous 36 months.
    (C) At least six of the continuing education units required in 
paragraph (a)(2)(iii)(A) of this section shall be related to each 
mammographic modality used by the technologist.
    (D) Requalification. Radiologic technologists who fail to meet the 
continuing education requirements of paragraph (a)(2)(iii)(A) of this 
section shall obtain a sufficient number of

[[Page 55986]]

continuing education units in mammography to bring their total up to at 
least 15 in the previous 3 years, at least 6 of which shall be related 
to each modality used by the technologist in mammography. The 
technologist may not resume performing unsupervised mammography 
examinations until the continuing education requirements are completed.
    (E) Before a radiologic technologist may begin independently 
performing mammographic examinations using a mammographic modality 
other than one of those for which the technologist received training 
under paragraph (a)(2)(ii)(C) of this section, the technologist shall 
have at least 8 hours of continuing education units in the new 
modality.
    (iv) Continuing experience requirements. (A) Following the second 
anniversary date of the end of the calendar quarter in which the 
requirements of paragraphs (a)(2)(i) and (a)(2)(ii) of this section 
were completed or of October 28, 1997 whichever is later, the 
radiologic technologist shall have performed a minimum of 200 
mammography examinations during the 24 months immediately preceding the 
date of the facility's annual MQSA inspection or the last day of the 
calendar quarter or any date in between the two. The facility will 
choose one of these dates to determine the 24-month period.
    (B) Requalification. Radiologic technologists who fail to meet the 
continuing experience requirements of paragraph (a)(2)(iv)(A) of this 
section shall perform a minimum of 25 mammography examinations under 
the direct supervision of a qualified radiologic technologist, before 
resuming the performance of unsupervised mammography examinations.
    (3) Medical physicists. All medical physicists conducting surveys 
of mammography facilities and providing oversight of the facility 
quality assurance program under paragraph (e) of this section shall 
meet the following:
    (i) Initial qualifications. (A) Be State licensed or approved or 
have certification in an appropriate specialty area by one of the 
bodies determined by FDA to have procedures and requirements to ensure 
that medical physicists certified by the body are competent to perform 
physics survey; and
    (B)(1) Have a masters degree or higher in a physical science from 
an accredited institution, with no less than 20 semester hours or 
equivalent (e.g., 30 quarter hours) of college undergraduate or 
graduate level physics;
    (2) Have 20 contact hours of documented specialized training in 
conducting surveys of mammography facilities; and
    (3) Have the experience of conducting surveys of at least 1 
mammography facility and a total of at least 10 mammography units. No 
more than one survey of a specific unit within a period of 60 days can 
be counted towards the total mammography unit survey requirement. After 
April 28, 1999 experience conducting surveys must be acquired under the 
direct supervision of a medical physicist who meets all the 
requirements of paragraphs (a)(3)(i) and (a)(3)(iii) of this section; 
or
    (ii) Alternative initial qualifications. (A) Have qualified as a 
medical physicist under paragraph (a)(3) of this section of FDA's 
interim regulations and retained that qualification by maintenance of 
the active status of any licensure, approval, or certification required 
under the interim regulations; and
    (B) Prior to the April 28, 1999 have:
    (1) A bachelor's degree or higher in a physical science from an 
accredited institution with no less than 10 semester hours or 
equivalent of college undergraduate or graduate level physics,
    (2) Forty contact hours of documented specialized training in 
conducting surveys of mammography facilities and,
    (3) Have the experience of conducting surveys of at least 1 
mammography facility and a total of at least 20 mammography units. No 
more than one survey of a specific unit within a period of 60 days can 
be counted towards the total mammography unit survey requirement. The 
training and experience requirements must be met after fulfilling the 
degree requirement.
    (iii) Continuing qualifications. (A) Continuing education. 
Following the third anniversary date of the end of the calendar quarter 
in which the requirements of paragraph (a)(3)(i) or (a)(3)(ii) of this 
section were completed, the medical physicist shall have taught or 
completed at least 15 continuing education units in mammography during 
the 36 months immediately preceding the date of the facility's annual 
inspection or the last day of the calendar quarter preceding the 
inspection or any date in between the two. The facility shall choose 
one of these dates to determine the 36-month period. This continuing 
education shall include hours of training appropriate to each 
mammographic modality evaluated by the medical physicist during his or 
her surveys or oversight of quality assurance programs. Units earned 
through teaching a specific course can be counted only once towards the 
required 15 units in a 36-month period, even if the course is taught 
multiple times during the 36 months.
    (B) Continuing experience. Following the second anniversary date of 
the end of the calendar quarter in which the requirements of paragraph 
(a)(3)(i) or (a)(3)(ii) of this section were completed or of October 
28, 1997 whichever is later, the medical physicist shall have surveyed 
at least two mammography facilities and a total of at least six 
mammography units during the 24 months immediately preceding the date 
of the facility's annual MQSA inspection or the last day of the 
calendar quarter or any date in-between the two. The facility shall 
choose one of these dates to determine the 24-month period. No more 
than one survey of a specific facility within a 10-month period on a 
specific unit within a period of 60 days can be counted towards the 
total mammography unit survey requirement.
    (C) Before a medical physicist may begin independently performing 
mammographic surveys of a new mammographic modality, that is, a 
mammographic modality other than one for which the physicist received 
training to qualify under paragraph (a)(3)(i) or (a)(3)(ii) of this 
section, the physicist must receive at least 8 hours of training in 
surveying units of the new mammographic modality.
    (iv) Reestablishing qualifications. Medical physicists who fail to 
maintain the required continuing qualifications of paragraph 
(a)(3)(iii) of this section may not perform the MQSA surveys without 
the supervision of a qualified medical physicist. Before independently 
surveying another facility, medical physicists must reestablish their 
qualifications, as follows:
    (A) Medical physicists who fail to meet the continuing educational 
requirements of paragraph (a)(3)(iii)(A) of this section shall obtain a 
sufficient number of continuing education units to bring their total 
units up to the required 15 in the previous 3 years.
    (B) Medical physicists who fail to meet the continuing experience 
requirement of paragraph (a)(3)(iii)(B) of this section shall complete 
a sufficient number of surveys under the direct supervision of a 
medical physicist who meets the qualifications of paragraphs (a)(3)(i) 
and (a)(3)(iii) of this section to bring their total surveys up to the 
required two facilities and six units in the previous 24 months. No 
more than one survey of a specific unit within a period of 60 days can 
be counted towards the total mammography unit survey requirement.

[[Page 55987]]

    (4) Retention of personnel records. Facilities shall maintain 
records to document the qualifications of all personnel who worked at 
the facility as interpreting physicians, radiologic technologists, or 
medical physicists. These records must be available for review by the 
MQSA inspectors. Records of personnel no longer employed by the 
facility should not be discarded until the next annual inspection has 
been completed and FDA has determined that the facility is in 
compliance with the MQSA personnel requirements.
    (b) Equipment. Regulations published under Secs. 1020.30, 1020.31, 
and 900.12(e) of this chapter that are relevant to equipment 
performance should also be consulted for a more complete understanding 
of the equipment performance requirements.
    (1) Prohibited equipment. Radiographic equipment designed for 
general purpose or special nonmammography procedures shall not be used 
for mammography. This prohibition includes systems that have been 
modified or equipped with special attachments for mammography. This 
requirement supersedes the implied acceptance of such systems in 
Sec. 1020.31(f)(3) of this chapter.
    (2) General. All radiographic equipment used for mammography shall 
be specifically designed for mammography and shall be certified 
pursuant to Sec. 1010.2 of this chapter as meeting the applicable 
requirements of Secs. 1020.30 and 1020.31 of this chapter in effect at 
the date of manufacture.
    (3) Motion of tube-image receptor assembly.  (i) The assembly shall 
be capable of being fixed in any position where it is designed to 
operate. Once fixed in any such position, it shall not undergo 
unintended motion.
    (ii) The mechanism ensuring compliance with paragraph (b)(3)(i) of 
this section shall not fail in the event of power interruption.
    (4) Image receptor sizes.  (i) Systems using screen-film image 
receptors shall provide, at a minimum, for operation with image 
receptors of 18 x 24 centimeters (cm) and 24 x 30 cm.
    (ii) Systems using screen-film image receptors shall be equipped 
with moving grids matched to all image receptor sizes provided.
    (iii) Systems used for magnification procedures shall be capable of 
operation with the grid removed from between the source and image 
receptor.
    (5) Beam limitation and light fields. (i) All systems shall have 
beam-limiting devices that allow the useful beam to extend to or beyond 
the chest wall edge of the image receptor.
    (ii) For any mammography system with a light beam that passes 
through the X-ray beam-limiting device, the light shall provide an 
average illumination of not less than 160 lux (15 foot candles) at 100 
cm or the maximum source-image receptor distance (SID), whichever is 
less.
    (6) Magnification. (i) Systems used to perform noninterventional 
problem solving procedures shall have radiographic magnification 
capability available for use by the operator.
    (ii) Systems used for magnification procedures shall provide, at a 
minimum, at least one magnification valve within the range of 1.4 to 
2.0.
    (7) Focal spot selection. (i) When more than one focal spot is 
provided, the system shall indicate, prior to exposure, which focal 
spot is selected.
    (ii) When more than one target material is provided, the system 
shall indicate, prior to exposure, the preselected target material.
    (iii) When the target material and/or focal spot is selected by a 
system algorithm that is based on the exposure or on a test exposure, 
the system shall display, after the exposure, the target material and/
or focal spot actually used during the exposure.
    (8) Compression. All mammography systems shall incorporate a 
compression device.
    (i) Application of compression. Effective October 28, 1999 each 
system shall provide:
    (A) An initial power-driven compression activated by hands-free 
controls operable from both sides of the patient; and
    (B) Fine adjustment compression controls operable from both sides 
of the patient.
    (ii) Compression paddle. (A) Systems shall be equipped with 
different sized compression paddles that match the sizes of all full-
field image receptors provided for the system. Compression paddles for 
special purposes, including those smaller than the full size of the 
image receptor (for ``spot compression'') may be provided. Such 
compression paddles for special purposes are not subject to the 
requirements of paragraphs (b)(8)(ii)(D) and (b)(8)(ii)(E) of this 
section.
    (B) Except as provided in paragraph (b)(8)(ii)(C) of this section, 
the compression paddle shall be flat and parallel to the breast support 
table and shall not deflect from parallel by more than 1.0 cm at any 
point on the surface of the compression paddle when compression is 
applied.
    (C) Equipment intended by the manufacturer's design to not be flat 
and parallel to the breast support table during compression shall meet 
the manufacturer's design specifications and maintenance requirements.
    (D) The chest wall edge of the compression paddle shall be straight 
and parallel to the edge of the image receptor.
    (E) The chest wall edge may be bent upward to allow for patient 
comfort but shall not appear on the image.
    (9) Technique factor selection and display. (i) Manual selection of 
milliampere seconds (mAs) or at least one of its component parts 
(milliapere (mA) and/or time) shall be available.
    (ii) The technique factors (peak tube potential in kilovolt (kV) 
and either tube current in mA and exposure time in seconds or the 
product of tube current and exposure time in mAs) to be used during an 
exposure shall be indicated before the exposure begins, except when 
automatic exposure controls (AEC) are used, in which case the technique 
factors that are set prior to the exposure shall be indicated.
    (iii) Following AEC mode use, the system shall indicate the actual 
kilovoltage peak (kVp) and mAs used during the exposure. The mAs may be 
displayed as mA and time.
    (10) Automatic exposure control.  (i) Each screen-film system shall 
provide an AEC mode that is operable in all combinations of equipment 
configuration provided, e.g., grid, nongrid; magnification, 
nonmagnification; and various target-filter combinations.
    (ii) The positioning or selection of the detector shall permit 
flexibility in the placement of the detector under the target tissue.
    (A) The size and available positions of the detector shall be 
clearly indicated at the X-ray input surface of the breast compression 
paddle.
    (B) The selected position of the detector shall be clearly 
indicated.
    (iii) The system shall provide means for the operator to vary the 
selected optical density from the normal (zero) setting.
    (11) X-ray film. The facility shall use X-ray film for mammography 
that has been designated by the film manufacturer as appropriate for 
mammography.
    (12) Intensifying screens. The facility shall use intensifying 
screens for mammography that have been designated by the screen 
manufacturer as appropriate for mammography and shall use film that is 
matched to the screen's spectral output as specified by the 
manufacturer.
    (13) Film processing solutions. For processing mammography films, 
the facility shall use chemical solutions that

[[Page 55988]]

are capable of developing the films used by the facility in a manner 
equivalent to the minimum requirements specified by the film 
manufacturer.
    (14) Lighting. The facility shall make special lights for film 
illumination, i.e., hot-lights, capable of producing light levels 
greater than that provided by the view box, available to the 
interpreting physicians.
    (15) Film masking devices. Facilities shall ensure that film 
masking devices that can limit the illuminated area to a region equal 
to or smaller than the exposed portion of the film are available to all 
interpreting physicians interpreting for the facility.
    (c) Medical records and mammography reports--(1) Contents and 
terminology. Each facility shall prepare a written report of the 
results of each mammography examination performed under its 
certificate. The mammography report shall include the following 
information:
    (i) The name of the patient and an additional patient identifier;
    (ii) Date of examination;
    (iii) The name of the interpreting physician who interpreted the 
mammogram;
    (iv) Overall final assessment of findings, classified in one of the 
following categories:
    (A) ``Negative:'' Nothing to comment upon (if the interpreting 
physician is aware of clinical findings or symptoms, despite the 
negative assessment, these shall be explained);
    (B) ``Benign:'' Also a negative assessment;
    (C) ``Probably Benign:'' Finding(s) has a high probability of being 
benign;
    (D) ``Suspicious:'' Finding(s) without all the characteristic 
morphology of breast cancer but indicating a definite probability of 
being malignant;
    (E) ``Highly suggestive of malignancy:'' Finding(s) has a high 
probability of being malignant;
    (v) In cases where no final assessment category can be assigned due 
to incomplete work-up, ``Incomplete: Need additional imaging 
evaluation'' shall be assigned as an assessment and reasons why no 
assessment can be made shall be stated by the interpreting physician; 
and
    (vi) Recommendations made to the health care provider about what 
additional actions, if any, should be taken. All clinical questions 
raised by the referring health care provider shall be addressed in the 
report to the extent possible, even if the assessment is negative or 
benign.
    (2) Communication of mammography results to the patient. Each 
facility shall maintain a system to ensure that the results of each 
mammographic examination are communicated to the patient in a timely 
manner. If assessments are ``Suspicious'' or ``Highly suggestive of 
malignancy'' and the patient has not named a health care provider, the 
facility shall make reasonable attempts to ensure that the results are 
communicated to the patient as soon as possible.
    (i) As soon as possible, but no later than 30 days from the date of 
the mammography examination, patients who do not name a health care 
provider to receive the mammography report shall be sent the report 
described in paragraph (c)(1) of this section, in addition to a written 
notification of results in lay terms.
    (ii) Each facility that accepts patients who do not have a primary 
care provider shall maintain a system for referring such patients to a 
health care provider when clinically indicated.
    (3) Communication of mammography results to health care providers. 
When the patient has a referring health care provider or the patient 
has named a health care provider, the facility shall:
    (i) Provide a written report of the mammography examination, 
including the items listed in paragraph (c)(1) of this section, to that 
health care provider as soon as possible, but no later than 30 days 
from the date of the mammography examination; and
    (ii) If the assessment is ``Suspicious'' or ``Highly suggestive of 
malignancy,'' make reasonable attempts to communicate with the health 
care provider as soon as possible, or if the health care provider is 
unavailable, to a responsible designee of the health care provider.
    (4) Recordkeeping. Each facility that performs mammograms:
    (i) Shall (except as provided in paragraph (c)(3)(ii) of this 
section) maintain mammography films and reports in a permanent medical 
record of the patient for a period of not less than 5 years, or not 
less than 10 years if no additional mammograms of the patient are 
performed at the facility, or a longer period if mandated by State or 
local law; and
    (ii) Shall upon request or on behalf of, by the patient, 
permanently or temporarily transfer the original mammograms and copies 
of the patient's reports to a medical institution, or to a physician or 
health care provider of the patient, or to the patient directly;
    (iii) Any fee charged to the patients for providing the services in 
paragraph (c)(4)(ii) of this section shall not exceed the documented 
costs associated with this service.
    (5) Mammographic image identification. Each mammographic image 
shall have the following information indicated on it in a permanent, 
legible, and unambiguous manner and placed so as not to obscure 
anatomic structures:
    (i) Name of patient and an additional patient identifier.
    (ii) Date of examination.
    (iii) View and laterality. This information shall be placed on the 
image in a position near the axilla. Standardized codes specified by 
the accreditation body and approved by FDA in accordance with 
Sec. 900.3(b) or Sec. 900.4(a)(8) shall be used to identify view and 
laterality.
    (iv) Facility name and location. At a minimum, the location shall 
include the city, State, and zip code of the facility.
    (v) Technologist identification.
    (vi) Cassette/screen identification.
    (vii) Mammography unit identification, if there is more than one 
unit in the facility.
    (d) Quality assurance--general. Each facility shall establish and 
maintain a quality assurance program to ensure the safety, reliability, 
clarity, and accuracy of mammography services performed at the 
facility.
    (1) Responsible individuals. Responsibility for the quality 
assurance program and for each of its elements shall be assigned to 
individuals who are qualified for their assignments and who shall be 
allowed adequate time to perform these duties.
    (i) Lead interpreting physician. The facility shall identify a lead 
interpreting physician who shall have the general responsibility of 
ensuring that the quality assurance program meets all requirements of 
paragraphs (d) through (f) of this section. No other individual shall 
be assigned or shall retain responsibility for quality assurance tasks 
unless the lead interpreting physician has determined that the 
individual's qualifications for, and performance of, the assignment are 
adequate.
    (ii) Interpreting physicians. All interpreting physicians 
interpreting mammograms for the facility shall:
    (A) Follow the facility procedures for corrective action when the 
images they are asked to interpret are of poor quality, and
    (B) Participate in the facility's medical outcomes audit program.
    (iii) Medical physicist. Each facility shall have the services of a 
medical physicist available to survey mammography equipment and oversee 
the equipment-related quality assurance practices of the facility. At a 
minimum, the medical physicist(s) shall be responsible for performing 
the surveys and mammography equipment

[[Page 55989]]

evaluations and providing the facility with the reports described in 
paragraphs (e)(9) and (e)(10) of this section.
    (iv) Quality control technologist. Responsibility for all 
individual tasks within the quality assurance program not assigned to 
the lead interpreting physician or the medical physicist shall be 
assigned to a quality control technologist(s). The tasks are to be 
performed by the quality control technologist or by other personnel 
qualified to perform the tasks. When other personnel are utilized for 
these tasks, the quality control technologist shall ensure that the 
tasks are completed in such a way as to meet the requirements of 
paragraph (e) of this section.
    (2) Quality assurance records. The lead interpreting physician, 
quality control technologist, and medical physicist shall ensure that 
records concerning employee qualifications to meet assigned quality 
assurance tasks, mammography technique and procedures, quality control 
(including monitoring data, problems detected by analysis of that data, 
corrective actions, and the effectiveness of the corrective actions), 
safety, and protection are properly maintained and updated. These 
quality control records shall be kept for each test specified in 
paragraphs (e) and (f) of this section until the next annual inspection 
has been completed and FDA has determined that the facility is in 
compliance with the quality assurance requirements or until the test 
has been performed two additional times at the required frequency, 
whichever is longer.
    (e) Quality assurance--equipment--(1) Daily quality control tests. 
Film processors used to develop mammograms shall be adjusted and 
maintained to meet the technical development specifications for the 
mammography film in use. A processor performance test shall be 
performed on each day that examinations are performed before any 
clinical films are processed that day. The test shall include an 
assessment of base plus fog density, mid-density, and density 
difference, using the mammography film used clinically at the facility.
    (i) The base plus fog density shall be within + 0.03 of the 
established operating level.
    (ii) The mid-density shall be within + 0.15 of the established 
operating level.
    (iii) The density difference shall be within + 0.15 of the 
established operating level.
    (2) Weekly quality control tests. Facilities with screen-film 
systems shall perform an image quality evaluation test, using an FDA-
approved phantom, at least weekly.
    (i) The optical density of the film at the center of an image of a 
standard FDA-accepted phantom shall be at least 1.20 when exposed under 
a typical clinical condition.
    (ii) The optical density of the film at the center of the phantom 
image shall not change by more than + 0.20 from the established 
operating level.
    (iii) The phantom image shall achieve at least the minimum score 
established by the accreditation body and accepted by FDA in accordance 
with Sec. 900.3(d) or Sec. 900.4(a)(8).
    (iv) The density difference between the background of the phantom 
and an added test object, used to assess image contrast, shall be 
measured and shall not vary by more than  0.05 from the 
established operating level.
    (3) Quarterly quality control tests. Facilities with screen-film 
systems shall perform the following quality control tests at least 
quarterly:
    (i) Fixer retention in film. The residual fixer shall be no more 
than 5 micrograms per square cm.
    (ii) Repeat analysis. If the total repeat or reject rate changes 
from the previously determined rate by more than 2.0 percent of the 
total films included in the analysis, the reason(s) for the change 
shall be determined. Any corrective actions shall be recorded and the 
results of these corrective actions shall be assessed.
    (4) Semiannual quality control tests. Facilities with screen-film 
systems shall perform the following quality control tests at least 
semiannually:
    (i) Darkroom fog. The optical density attributable to darkroom fog 
shall not exceed 0.05 when a mammography film of the type used in the 
facility, which has a mid-density of no less than 1.2 OD, is exposed to 
typical darkroom conditions for 2 minutes while such film is placed on 
the counter top emulsion side up. If the darkroom has a safelight used 
for mammography film, it shall be on during this test.
    (ii) Screen-film contact. Testing for screen-film contact shall be 
conducted using 40 mesh copper screen. All cassettes used in the 
facility for mammography shall be tested.
    (iii) Compression device performance. (A) A compression force of at 
least 111 newtons (25 pounds) shall be provided.
    (B) Effective October 28, 1999 the maximum compression force for 
the initial power drive shall be between 111 newtons (25 pounds) and 
209 newtons (47 pounds).
    (5) Annual quality control tests. Facilities with screen-film 
systems shall perform the following quality control tests at least 
annually:
    (i) Automatic exposure control performance. (A) The AEC shall be 
capable of maintaining film optical density within  0.30 of 
the mean optical density when thickness of a homogeneous material is 
varied over a range of 2 to 6 cm and the kVp is varied appropriately 
for such thicknesses over the kVp range used clinically in the 
facility. If this requirement cannot be met, a technique chart shall be 
developed showing appropriate techniques (kVp and density control 
settings) for different breast thicknesses and compositions that must 
be used so that optical densities within  0.30 of the 
average under phototimed conditions can be produced.
    (B) After October 28, 1999 the AEC shall be capable of maintaining 
film optical density (OD) within  0.15 of the mean optical 
density when thickness of a homogeneous material is varied over a range 
of 2 to 6 cm and the kVp is varied appropriately for such thicknesses 
over the kVp range used clinically in the facility.
    (C) The optical density of the film in the center of the phantom 
image shall not be less than 1.20.
    (ii) Kilovoltage peak (kVp) accuracy and reproducibility. (A) The 
kVp shall be accurate within + 5 percent of the indicated or selected 
kVp at:
    (1) The lowest clinical kVp that can be measured by a kVp test 
device;
    (2) The most commonly used clinical kVp;
    (3) The highest available clinical kVp, and
    (B) At the most commonly used clinical settings of kVp, the 
coefficient of variation of reproducibility of the kVp shall be equal 
to or less than 0.02.
    (iii) Focal spot condition. Until October 28, 1999 focal spot 
condition shall be evaluated either by determining system resolution or 
by measuring focal spot dimensions. After October 28, 1999 facilities 
shall evaluate focal spot condition only by determining the system 
resolution.
    (A) System Resolution. (1) Each X-ray system used for mammography, 
in combination with the mammography screen-film combination used in the 
facility, shall provide a minimum resolution of 11 Cycles/millimeters 
(mm) (line-pairs/mm) when a high contrast resolution bar test pattern 
is oriented with the bars perpendicular to the anode-cathode axis, and 
a minimum resolution of 13 line-pairs/mm when the bars are parallel to 
that axis.
    (2) The bar pattern shall be placed 4.5 cm above the breast support 
surface, centered with respect to the chest wall

[[Page 55990]]

edge of the image receptor, and with the edge of the pattern within 1 
cm of the chest wall edge of the image receptor.
    (3) When more than one target material is provided, the measurement 
in paragraph (e)(5)(iii)(A) of this section shall be made using the 
appropriate focal spot for each target material.
    (4) When more than one SID is provided, the test shall be performed 
at SID most commonly used clinically.
    (5) Test kVp shall be set at the value used clinically by the 
facility for a standard breast and shall be performed in the AEC mode, 
if available. If necessary, a suitable absorber may be placed in the 
beam to increase exposure times. The screen-film cassette combination 
used by the facility shall be used to test for this requirement and 
shall be placed in the normal location used for clinical procedures.
    (B) Focal spot dimensions. Measured values of the focal spot length 
(dimension parallel to the anode cathode axis) and width (dimension 
perpendicular to the anode cathode axis) shall be within the tolerance 
limits specified in Table 1.

                                                     Table 1                                                    
----------------------------------------------------------------------------------------------------------------
                                           Focal Spot Tolerance Limit                                           
-----------------------------------------------------------------------------------------------------------------
                                                              Maximum Measured Dimensions                       
    Nominal Focal Spot Size (mm)     ---------------------------------------------------------------------------
                                                    Width(mm)                            Length(mm)             
----------------------------------------------------------------------------------------------------------------
0.10................................                            0.15                                  0.15      
0.15................................                            0.23                                  0.23      
0.20................................                            0.30                                  0.30      
0.30................................                            0.45                                  0.65      
0.40................................                            0.60                                  0.85      
0.60................................                            0.90                                  1.30      
----------------------------------------------------------------------------------------------------------------

    (iv) Beam quality and half-value layer (HVL). The HVL shall meet 
the specifications of Sec. 1020.30(m)(1) of this chapter for the 
minimum HVL. These values, extrapolated to the mammographic range, are 
shown in Table 2. Values not shown in Table 2 may be determined by 
linear interpolation or extrapolation.

                                 Table 2                                
------------------------------------------------------------------------
           X-ray Tube Voltage (kilovolt peak) and Minimum HVL           
-------------------------------------------------------------------------
                                                          Minimum HVL   
  Designed Operating Range (kV)   Measured Operating    (millimeters of 
                                     Voltage (kV)          aluminum)    
------------------------------------------------------------------------
Below 50                                   20                   0.20    
                                           25                   0.25    
                                           30                   0.30    
------------------------------------------------------------------------

    (v) Breast entrance air kerma and AEC reproducibility. The 
coefficient of variation for both air kerma and mAs shall not exceed 
0.05.
    (vi) Dosimetry. The average glandular dose delivered during a 
single cranio-caudal view of an FDA-accepted phantom simulating a 
standard breast shall not exceed 3.0 milligray (mGy) (0.3 rad) per 
exposure. The dose shall be determined with technique factors and 
conditions used clinically for a standard breast.
    (vii) X-ray field/light field/image receptor/compression paddle 
alignment. (A) All systems shall have beam-limiting devices that allow 
the useful X-ray beam to extend to or beyond the edges of the image 
receptor but by no more than 2 percent of the SID at the chest wall 
side.
    (B) If a light field that passes through the X-ray beam limitation 
device is provided, it shall be aligned with the X-ray field so that 
the total of any misalignment of the edges of the light field and the 
X-ray field along either the length or the width of the visually 
defined field at the plane of the breast support surface shall not 
exceed 2 percent of the SID.
    (C) The chest wall edge of the compression paddle shall not extend 
beyond the chest wall edge of the image receptor by more than one 
percent of the SID when tested with the compression paddle placed above 
the breast support surface at a distance equivalent to standard breast 
thickness. The shadow of the vertical edge of the compression paddle 
shall not be visible on the image.
    (viii) Uniformity of screen speed. Uniformity of screen speed of 
all the cassettes in the facility shall be tested and the difference 
between the maximum and minimum optical densities shall not exceed 
0.30. Screen artifacts shall also be evaluated during this test.
    (ix) System artifacts. System artifacts shall be evaluated with a 
high-grade, defect-free sheet of homogeneous material large enough to 
cover the mammography cassette and shall be performed for all cassette 
sizes used in the facility using a grid appropriate for the cassette 
size being tested. System artifacts shall also be evaluated for all 
available focal spot sizes and target filter combinations used 
clinically.
    (x) Radiation output. (A) The system shall be capable of producing 
a minimum output of 4.5 mGy air kerma per second (513 milli Roentgen 
(mR) per second) when operating at 28 kVp in the standard mammography 
(moly/moly) mode at any SID where the system is designed to operate and 
when measured by a detector with its center located 4.5 cm above the 
breast support surface with the compression paddle in place between the 
source and the detector. After October 28, 1999 the system, under the 
same measuring conditions shall be capable of producing a minimum 
output of 7.0 mGy air kerma per second (800 mR per second) when 
operating at 28 kVp in the standard (moly/moly) mammography mode at any 
SID where the system is designed to operate.

[[Page 55991]]

    (B) The system shall be capable of maintaining the required minimum 
radiation output averaged over a 3.0 second period.
    (xi) Decompression. If the system is equipped with a provision for 
automatic decompression after completion of an exposure or interruption 
of power to the system, the system shall be tested to confirm that it 
provides:
    (A) An override capability to allow maintenance of compression;
    (B) A continuous display of the override status; and
    (C) A manual emergency compression release that can be activated in 
the event of power or automatic release failure.
    (6) Quality control tests--other modalities. For systems with image 
receptor modalities other than screen-film, the quality assurance 
program shall be substantially the same as the quality assurance 
program recommended by the image receptor manufacturer, except that the 
maximum allowable dose shall not exceed the maximum allowable dose for 
screen-film systems in paragraph (e)(5)(vi) of this section.
    (7) Mobile Units. The facility shall verify that mammography units 
used to produce mammograms at more than one location meet the 
requirements in paragraphs (e)(1) through (e)(6) of this section. In 
addition, at each examination location, before any examinations are 
conducted, the facility shall verify satisfactory performance of such 
units using a test method that establishes the adequacy of the image 
quality produced by the unit.
    (8) Use of test results. (i) After completion of the tests 
specified in paragraphs (e)(1) through (e)(7) of this section, the 
facility shall compare the test results to the corresponding specified 
action limits; or, for nonscreen-film modalities, to the manufacturer's 
recommended action limits; or, for post-move, preexamination testing of 
mobile units, to the limits established in the test method used by the 
facility.
    (ii) If the test results fall outside of the action limits, the 
source of the problem shall be identified and corrective actions shall 
be taken:
    (A) Before any further examinations are performed or any films are 
processed using the component of the mammography system that failed the 
test, if the failed test was that described in paragraphs (e)(1), 
(e)(2), (e)(4)(ii), (e)(4)(iii), (e)(5)(i), (e)(5)(iii), (e)(5)(v), 
(e)(5)(vi), (e)(6), or (e)(7) of this section;
    (B) Within 30 days of the test date for all other tests described 
in paragraph (e) of this section.
    (9) Surveys.  (i) At least once a year, each facility shall undergo 
a survey by a medical physicist or by an individual under the direct 
supervision of a medical physicist. At a minimum, this survey shall 
include the performance of tests to ensure that the facility meets the 
quality assurance requirements of the annual tests described in 
paragraphs (e)(5) and (e)(6) of this section and the weekly phantom 
image quality test described in paragraph (e)(2) of this section.
    (ii) The results of all tests conducted by the facility in 
accordance with paragraphs (e)(1) through (e)(7) of this section, as 
well as written documentation of any corrective actions taken and their 
results, shall be evaluated for adequacy by the medical physicist 
performing the survey.
    (iii) The medical physicist shall prepare a survey report that 
includes a summary of this review and recommendations for necessary 
improvements.
    (iv) The survey report shall be sent to the facility within 30 days 
of the date of the survey.
    (v) The survey report shall be dated and signed by the medical 
physicist performing or supervising the survey. If the survey was 
performed entirely or in part by another individual under the direct 
supervision of the medical physicist, that individual and the part of 
the survey that individual performed shall also be identified in the 
survey report.
    (10) Mammography equipment evaluations. Additional evaluations of 
mammography units or image processors shall be conducted whenever a new 
unit or processor is installed, a unit or processor is dissembled and 
reassembled at the same or a new location, or major components of a 
mammography unit or processor equipment are changed or repaired. These 
evaluations shall be used to determine whether the new or changed 
equipment meets the requirements of applicable standards in paragraphs 
(b) and (e) of this section. All problems shall be corrected before the 
new or changed equipment is put into service for examinations or film 
processing. The mammography equipment evaluation shall be performed by 
a medical physicist or by an individual under the direct supervision of 
a medical physicist.
    (11) Facility cleanliness.  (i) The facility shall establish and 
implement adequate protocols for maintaining darkroom, screen, and view 
box cleanliness.
    (ii) The facility shall document that all cleaning procedures are 
performed at the frequencies specified in the protocols.
    (12) Calibration of air kerma measuring instruments. Instruments 
used by medical physicists in their annual survey to measure the air 
kerma or air kerma rate from a mammography unit shall be calibrated at 
least once every 2 years and each time the instrument is repaired. The 
instrument calibration must be traceable to a national standard and 
calibrated with an accuracy of + 6 percent (95 percent confidence 
level) in the mammography energy range.
    (13) Infection control. Facilities shall establish and comply with 
a system specifying procedures to be followed by the facility for 
cleaning and disinfecting mammography equipment after contact with 
blood or other potentially infectious materials. This system shall 
specify the methods for documenting facility compliance with the 
infection control procedures established and shall:
    (i) Comply with all applicable Federal, State, and local 
regulations pertaining to infection control; and
    (ii) Comply with the manufacturer's recommended procedures for the 
cleaning and disinfection of the mammography equipment used in the 
facility; or
    (iii) If adequate manufacturer's recommendations are not available, 
comply with generally accepted guidance on infection control, until 
such recommendations become available.
    (f) Quality assurance-mammography medical outcomes audit. Each 
facility shall establish and maintain a mammography medical outcomes 
audit program to followup positive mammographic assessments and to 
correlate pathology results with the interpreting physician's findings. 
This program shall be designed to ensure the reliability, clarity, and 
accuracy of the interpretation of mammograms.
    (1) General requirements. Each facility shall establish a system to 
collect and review outcome data for all mammograms performed, including 
followup on the disposition of all positive mammograms and correlation 
of pathology results with the interpreting physician's mammography 
report. Analysis of these outcome data shall be made individually and 
collectively for all interpreting physicians at the facility. In 
addition, any cases of breast cancer among women imaged at the facility 
that subsequently become known to the facility shall prompt the 
facility to initiate followup on surgical and/or pathology results and 
review of the

[[Page 55992]]

mammograms taken prior to the diagnosis of a malignancy.
    (2) Frequency of audit analysis. The facility's first audit 
analysis shall be initiated no later than 12 months after the date the 
facility becomes certified, or 12 months after April 28, 1999 whichever 
date is the latest. This audit analysis shall be completed within an 
additional 12 months to permit completion of diagnostic procedures and 
data collection. Subsequent audit analyses will be conducted at least 
once every 12 months.
    (3) Reviewing interpreting physician. Each facility shall designate 
at least one interpreting physician to review the medical outcomes 
audit data at least once every 12 months. This individual shall record 
the dates of the audit period(s) and shall be responsible for analyzing 
results based on this audit. This individual shall also be responsible 
for documenting the results, notifying other interpreting physicians of 
their results and the facility aggregate results. If followup actions 
are taken, the reviewing interpreting physician shall also be 
responsible for documenting the nature of the followup.
    (g) Mammographic procedure and techniques for mammography of 
patients with breast implants. (1) Each facility shall have a procedure 
to inquire whether or not the patient has breast implants prior to the 
actual mammographic exam.
    (2) Except where contraindicated, or unless modified by a 
physician's directions, patients with breast implants undergoing 
mammography shall have mammographic views to maximize the visualization 
of breast tissue.
    (h) Consumer compliant mechanism. Each facility shall:
    (1) Establish a written and documented system for collecting and 
resolving consumer complaints;
    (2) Maintain a record of each serious complaint received by the 
facility for at least 3 years from the date the complaint was received;
    (3) Provide the consumer with adequate directions for filing 
serious complaints with the facility's accreditation body if the 
facility is unable to resolve a serious complaint to the consumer's 
satisfaction;
    (4) Report unresolved serious complaints to the accreditation body 
in a manner and timeframe specified by the accreditation body.
    (i) Clinical image quality. Clinical images produced by any 
certified facility must continue to comply with the standards for 
clinical image quality established by that facility's accreditation 
body.
    (j) Additional mammography review and patient notification. (1) If 
FDA believes that mammography quality at a facility has been 
compromised and may present a serious risk to human health, the 
facility shall provide clinical images and other relevant information, 
as specified by FDA, for review by the accreditation body or other 
entity designated by FDA. This additional mammography review will help 
the agency to determine whether the facility is in compliance with this 
section and, if not, whether there is a need to notify affected 
patients, their physicians, or the public that the reliability, 
clarity, and accuracy of interpretation of mammograms has been 
compromised.
    (2) If FDA determines that any activity related to the provision of 
mammography at a facility may present a serious risk to human health 
such that patient notification is necessary, the facility shall notify 
patients or their designees, their physicians, or the public of action 
that may be taken to minimize the effects of the risk. Such 
notification shall occur within a timeframe and in a manner specified 
by FDA.


Sec. 900.13  Revocation of accreditation and revocation ofaccreditation 
body approval.

    (a) FDA action following revocation of accreditation. If a 
facility's accreditation is revoked by an accreditation body, the 
agency may conduct an investigation into the reasons for the 
revocation. Following such investigation, the agency may determine that 
the facility's certificate shall no longer be in effect or the agency 
may take whatever other action or combination of actions will best 
protect the public health, including the establishment and 
implementation of a corrective plan of action that will permit the 
certificate to continue in effect while the facility seeks 
reaccreditation. A facility whose certificate is no longer in effect 
because it has lost its accreditation may not practice mammography.
    (b) Withdrawal of FDA approval of an accreditation body. (1) If FDA 
withdraws approval of an accreditation body under Sec. 900.6, the 
certificates of facilities previously accredited by such body shall 
remain in effect for up to 1 year from the date of the withdrawal of 
approval, unless FDA determines, in order to protect human health or 
because the accreditation body fraudulently accredited facilities, that 
the certificates of some or all of the facilities should be revoked or 
suspended or that a shorter time period should be established for the 
certificates to remain in effect.
    (2) After 1 year from the date of withdrawal of approval of an 
accreditation body, or within any shorter period of time established by 
the agency, the affected facilities must obtain accreditation from 
another accreditation body, or from another entity designated by FDA.


Sec. 900.14  Suspension or revocation of certificates.

    (a) Except as provided in paragraph (b) of this section, FDA may 
suspend or revoke a certificate if FDA finds, after providing the owner 
or operator of the facility with notice and opportunity for an informal 
hearing in accordance with part 16 of this chapter, that the owner, 
operator, or any employee of the facility:
    (1) Has been guilty of misrepresentation in obtaining the 
certificate;
    (2) Has failed to comply with the standards of Sec. 900.12;
    (3) Has failed to comply with reasonable requests of the agency or 
the accreditation body for records, information, reports, or materials 
that FDA believes are necessary to determine the continued eligibility 
of the facility for a certificate or continued compliance with the 
standards of Sec. 900.12;
    (4) Has refused a reasonable request of a duly designated FDA 
inspector, State inspector, or accreditation body representative for 
permission to inspect the facility or the operations and pertinent 
records of the facility;
    (5) Has violated or aided and abetted in the violation of any 
provision of or regulation promulgated pursuant to 42 U.S.C. 263b; or
    (6) Has failed to comply with prior sanctions imposed by the agency 
under 42 U.S.C. 263b(h).
    (b) FDA may suspend the certificate of a facility before holding a 
hearing if FDA makes a finding described in paragraph (a) of this 
section and also determines that;
    (1) The failure to comply with required standards presents a 
serious risk to human health;
    (2) The refusal to permit inspection makes immediate suspension 
necessary; or
    (3) There is reason to believe that the violation or aiding and 
abetting of the violation was intentional or associated with fraud.
    (c) If FDA suspends a certificate in accordance with paragraph (b) 
of this section:
    (1) The agency shall provide the facility with an opportunity for 
an informal hearing under part 16 of this chapter not later than 60 
days from the effective date of this suspension;
    (2) The suspension shall remain in effect until the agency 
determines that:

[[Page 55993]]

    (i) Allegations of violations or misconduct were not substantiated;
    (ii) Violations of required standards have been corrected to the 
agency's satisfaction; or
    (iii) The facility's certificate is revoked in accordance with 
paragraph (d) of this section;
    (d) After providing a hearing in accordance with paragraph (c)(1) 
of this section, the agency may revoke the facility's certificate if 
the agency determines that the facility:
    (1) Is unwilling or unable to correct violations that were the 
basis for suspension; or
    (2) Has engaged in fraudulent activity to obtain or continue 
certification.


Sec. 900.15  Appeals of adverse accreditation or reaccreditation 
decisions that preclude certification or recertification.

    (a) The appeals procedures described in this section are available 
only for adverse accreditation or reaccreditation decisions that 
preclude certification or recertification by FDA. Agency decisions to 
suspend or revoke certificates that are already in effect will be 
handled in accordance with Sec. 900.14.
    (b) Upon learning that a facility has failed to become accredited 
or reaccredited, FDA will notify the facility that the agency is unable 
to certify that facility without proof of accreditation.
    (c) A facility that has been denied accreditation or 
reaccreditation is entitled to an appeals process from the 
accreditation body, in accordance with Sec. 900.7. A facility must 
avail itself of the accreditation body's appeal process before 
requesting reconsideration from FDA.
    (d) A facility that cannot achieve satisfactory resolution of an 
adverse accreditation decision through the accreditation body's appeal 
process is entitled to further appeal in accordance with procedures set 
forth in this section and in regulations published in 42 CFR part 498.
    (1) References to the Health Care Financing Administration (HCFA) 
in 42 CFR part 498 should be read as the Division of Mammography 
Quality and Radiation Programs (DMQRP), Center for Devices and 
Radiological Health, Food and Drug Administration.
    (2) References to the Appeals Council of the Social Security 
Administration in 42 CFR part 498 should be read as references to the 
Departmental Appeals Board.
    (3) In accordance with the procedures set forth in subpart B of 42 
CFR part 498, a facility that has been denied accreditation following 
appeal to the accreditation body may request reconsideration of that 
adverse decision from DMQRP.
    (i) A facility must request reconsideration by DMQRP within 60 days 
of the accreditation body's adverse appeals decision, at the following 
address: Division of Mammography Quality and Radiation Programs (HFZ-
240), Center for Devices and Radiological Health, Food and Drug 
Administration, 1350 Piccard Dr., Rockville, MD 20850, Attn: Facility 
Accreditation Review Committee.
    (ii) The request for reconsideration shall include three copies of 
the following records:
    (A) The accreditation body's original denial of accreditation.
    (B) All information the facility submitted to the accreditation 
body as part of the appeals process;
    (C) A copy of the accreditation body's adverse appeals decision; 
and
    (D) A statement of the basis for the facility's disagreement with 
the accreditation body's decision.
    (iii) DMQRP will conduct its reconsideration in accordance with the 
procedures set forth in subpart B of 42 CFR part 498.
    (4) A facility that is dissatisfied with DMQRP's decision following 
reconsideration is entitled to a formal hearing in accordance with 
procedures set forth in subpart D of 42 CFR part 498.
    (5) Either the facility or FDA may request review of the hearing 
officer's decision. Such review will be conducted by the Departmental 
Appeals Board in accordance with subpart E of 42 CFR part 498.
    (6) A facility cannot perform mammography services while an adverse 
accreditation decision is being appealed.


Sec. 900.16  Appeals of denials of certification.

    (a) The appeals procedures described in this section are available 
only to facilities that are denied certification by FDA after they have 
been accredited by an approved accreditation body. Appeals for 
facilities that have failed to become accredited are governed by the 
procedures set forth in Sec. 900.15.
    (b) FDA may deny the application if the agency has reason to 
believe that:
    (1) The facility will not be operated in accordance with standards 
established under Sec. 900.12;
    (2) The facility will not permit inspections or provide access to 
records or information in a timely fashion; or
    (3) The facility has been guilty of misrepresentation in obtaining 
the accreditation.
    (c)(1) If FDA denies an application for certification by a faciity 
that has received accreditation from an approved accreditation body, 
FDA shall provide the facility with a statement of the grounds on which 
the denial is based.
    (2) A facility that has been denied accreditation may request 
reconsideration and appeal of FDA's determination in accordance with 
the applicable provisions of Sec. 900.15(d).
Sec. 900.17 [Reserved]


Sec. 900.18  Alternative requirements for Sec. 900.12 quality 
standards.

    (a) Criteria for approval of alternative standards. Upon 
application by a qualified party as defined in paragraph (b) of this 
section, FDA may approve an alternative to a quality standard under 
Sec. 900.12, when the agency determines that:
    (1) The proposed alternative standard will be at least as effective 
in assuing quality mammography as the standard it proposes to replace, 
and
    (2) The proposed alternative:
    (i) Is too limited in its applicability to justify an amendment to 
the standard; or
    (ii) Offers an expected benefit to human health that is so great 
that the time required for amending the standard would present an 
unjustifiable risk to the human health; and
    (3) The granting of the alternative is in keeping with the purposes 
of 42 U.S.C. 263b.
    (b) Applicants for alternatives. (1) Mammography facilities and 
accreditation bodies may apply for alternatives to the quality 
standards of Sec. 900.12.
    (2) Federal agencies and State governments that are not 
accreditation bodies may apply for alternatives to the standards of 
Sec. 900.12(a).
    (3) Manufacturers and assemblers of equipment used for mammography 
may apply for alternatives to the standards of Sec. 900.12(b) and (e).
    (c) Applications for approval of an alternative standard. An 
application for approval of an alternative standard or for an amendment 
or extension of the alternative standard shall be submitted in an 
original and two copies to the Director, Division of Mammography 
Quality and Radiation Programs (HFZ-240), Center for Devices and 
Radiological Health, Food and Drug Administration, 1350 Piccard Dr., 
Rockville, MD 20850. The application for approval of an alternative 
standard shall include the following information:
    (1) Identification of the original standard for which the 
alternative standard is being proposed and an explanation of why the 
applicant is proposing the alternative;
    (2) A description of the manner in which the alternative is 
proposed to deviate from the original standard;

[[Page 55994]]

    (3) A description, supported by data, of the advantages to be 
derived from such deviation;
    (4) An explanation, supported by data, of how such a deviation 
would ensure equal or greater quality of production, processing, or 
interpretation of mammograms than the original standard;
    (5) The suggested period of time that the proposed alternative 
standard would be in effect; and
    (6) Such other information required by the Director to evaluate and 
act on the application.
    (d) Ruling on applications.  (1) FDA may approve or deny, in whole 
or in part, a request for approval of an alternative standard or any 
amendment or extension thereof, and shall inform the applicant in 
writing of this action. The written notice shall state the manner in 
which the requested alternative standard differs from the agency 
standard and a summary of the reasons for approval or denial of the 
request. If the request is approved, the written notice shall also 
include the effective date and the termination date of the approval and 
a summary of the limitations and conditions attached to the approval 
and any other information that may be relevant to the approved request. 
Each approved alternative standard shall be assigned an identifying 
number.
    (2) Notice of an approved request for an alternative standard or 
any amendment or extension thereof shall be placed in the public docket 
file in the Dockets Management Branch and may also be in the form of a 
notice published in the Federal Register. The notice shall state the 
name of the applicant, a description of the published agency standard, 
and a description of the approved alternative standard, including 
limitations and conditions attached to the approval of the alternative 
standard.
    (3) Summaries of the approval of alternative standards, including 
information on their nature and number, shall be provided to the 
National Mammography Quality Assurance Advisory Committee.
    (4) All applications for approval of alternative standards and for 
amendments and extensions thereof and all correspondence (including 
written notices of approval) on these applications shall be available 
for public disclosure in the Dockets Management Branch, excluding 
patient identifiers and confidential commercial information.
    (e) Amendment or extension of an alternative standard. An 
application for amending or extending approval of an alternative 
standard shall include the following information:
    (1) The approval number and the expiration date of the alternative 
standard;
    (2) The amendment or extension requested and the basis for the 
amendment or extension; and
    (3) An explanation, supported by data, of how such an amendment or 
extension would ensure equal or greater quality of production, 
processing, or interpretation of mammograms than the original standard.
    (f) Applicability of the alternative standards. (1) Except as 
provided in paragraphs (f)(2) and (f)(3) of this section, any approval 
of an alternative standard, amendment, or extension may be implemented 
only by the entity to which it was granted and under the terms under 
which it was granted. Other entities interested in similar or identical 
approvals must file their own application following the procedures of 
paragraph (c) of this section.
    (2) When an alternative standard is approved for a manufacturer of 
equipment, any facility using that equipment will also be covered by 
the alternative standard.
    (3) The agency may extend the alternative standard to other 
entities when FDA determines that expansion of the approval of the 
alternative standard would be an effective means of promoting the 
acceptance of measures to improve the quality of mammography. All such 
determinations will be publicized by appropriate means.
    (g) Withdrawal of approval of alternative requirements. FDA shall 
amend or withdraw approval of an alternative standard whenever the 
agency determines that this action is necessary to protect the human 
health or otherwise is justified by Sec. 900.12. Such action will 
become effective on the date specified in the written notice of the 
action sent to the applicant, except that it will become effective 
immediately upon notification of the applicant when FDA determines that 
such action is necessary to prevent an imminent health hazard.

    Dated: September 25, 1997.
Michael A. Friedman,
Lead Deputy Commissioner for the Food and Drug Administration.
Donna E. Shalala,
Secretary of Health and Human Services.
[FR Doc. 97-26351 Filed 10-27-97; 8:45 am]
BILLING CODE 4160-01-F