[Federal Register Volume 62, Number 217 (Monday, November 10, 1997)]
[Rules and Regulations]
[Pages 60614-60632]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-29596]



[[Page 60613]]

_______________________________________________________________________

Part IV





Department of Health and Human Services





_______________________________________________________________________



Food and Drug Administration



_______________________________________________________________________



21 CFR Parts 16 and 900



Quality Mammography Standards; Correction; Final Rule

  Federal Register / Vol. 62, No. 217 / Monday, November 10, 1997 / 
Rules and Regulations  

[[Page 60614]]



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; Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; correction.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is correcting a 
document entitled ``Quality Mammography Standards'' that appeared in 
the Federal Register of October 28, 1997. The document was published 
with some inadvertent typographical errors and incorrect dates in the 
regulatory text. This document corrects those errors. FDA is also 
identifying with greater specificity those sections of the quality 
standards that will become effective October 28, 2002. For the 
convenience of the reader, FDA is republishing 21 CFR part 900 in its 
entirety with corrections.

DATES: This regulation is effective April 28, 1999; except 
Sec. 900.12(b)(8)(i), (e)(4)(iii)(B), (e)(5)(i)(B) 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: In FR Doc. 97-26351, appearing on page 55852 
in the Federal Register of Tuesday, October 28, 1997, the following 
corrections are made:
    1. On page 55852, in the first column, the ``DATES'' section is 
corrected as set forth above.
    2. On page 55854, in the first column, in the third full paragraph, 
line 12, ``Mammography Matters'' should be italicized.
    3. On page 55872, in the first column, in the fourth full 
paragraph, in line 14, the ``+'' sign is corrected to read 
``''.
    4. On page 55895, in the second column, in the fifth paragraph, in 
line 16, ``gi11'' is removed and the paragraph is indented at 
``(Comment 225)''.
    5. On page 55919, in the third column, in the fourth full 
paragraph, in line 4, in the fifth full paragraph, in line 5, and in 
the sixth full paragraph, in line 5, the ``+'' sign is corrected to 
read ``''.
    6. On page 55920, in the first column, in lines 1 and 6, the ``+'' 
sign is corrected to read ``''; and in the second column, 
in the first full paragraph, in line 7, ``(10-4'' is corrected to read 
``(10-4''.
    7. On page 55930, in the second column, in the third line from the 
bottom, the word ``patents'' is corrected to read ``patients''.
    8. On page 55938, in the third column, in the second full 
paragraph, in line 19, ``advided'' is corrected to read ``advised''.
    9. On page 55954, in the first column, in the seventh paragraph, 
beginning in line 6, ``Journal of the Medical Association'' should be 
italicized.
    10. On page 55967, in the first column, in the third line from the 
bottom of the page, ``becauseit'' is corrected to read ``because it''.
    11. On page 55975, in the second column, in the second full 
paragraph, line 7, ``(C).'' is corrected to read ``. (C)''; and in the 
third full paragraph, in line 4, ``(B).'' is corrected to read ``. 
(B)''.
    12. On page 55976, in the second column, in reference 5, in line 2, 
``'' is corrected to read ``''; and in line 3, 
``1995-1993'' is corrected to read ``1993-1995''.


Part 16  [Corrected]

    13. On page 55976, in the authority citation for 21 CFR part 16, 
``41-40'' is corrected to read ``40-41''; and in amendatory instruction 
2., in the section heading, ``Sec. 716.1'' is corrected to read 
``Sec. 16.1''.


Sec. 900.3  [Corrected]

    14. On page 55979, in the second column in Sec. 900.3(c)(4), a 
comma is inserted after ``July 28, 1998''.


Sec. 900.12  [Corrected]

    15. On page 55986, in the first column, in the introductory text of 
Sec. 900.12(a)(2)(iv), a comma is inserted after ``October 28, 1997''.
    16. On page 55987, in the second column, in Sec. 900.12(b)(6)(ii) 
the word ``valve'' is corrected to read ``value''; in 
Sec. 900.12(b)(8)(i), ``October 28, 1999'' is corrected to read 
``October 28, 2002''.
    17. On page 55989, in the first column, in Sec. 900.12(e)(1)(ii), 
(iii), (e)(2)(ii), and (e)(5)(ii) the ``+'' sign is corrected to read 
``''; and in Sec. 900.12(e)(4)(iii)(B), (e)(5)(i)(B), and 
(e)(5)(iii) ``October 28, 1999'' is corrected to read ``October 28, 
2002'' each time it appears.
    18. On page 55990, in the third column, in Sec. 900.12(e)(5)(x)(A), 
``October 28, 1999'' is corrected to read ``October 28, 2002''.
    19. On page 55991, in the third column, in Sec. 900.12(e)(12) the 
``+'' sign is corrected to read ``''.
    20. On page 55992, in the heading for Sec. 900.12(h), the word 
``compliant'' is corrected to read ``complaint''.


Sec. 900.18  [Corrected]

    21. On page 55993, in Sec. 900.18(a)(1), the word ``assuing'' is 
corrected to read ``assuring''.
    As corrected, 21 CFR part 900 is republished 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.
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

[[Page 60615]]

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.
    (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

[[Page 60616]]

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;
    (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

[[Page 60617]]

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.
    (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:

[[Page 60618]]

    (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.
    (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.

[[Page 60619]]

    (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.
    (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;

[[Page 60620]]

    (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 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

[[Page 60621]]

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 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

[[Page 60622]]

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 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,

[[Page 60623]]

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 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

[[Page 60624]]

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 22, 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 22, 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.
    (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

[[Page 60625]]

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 value 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, 2002, 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 (mA's) 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 mA's) 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 mA's used during the exposure. The mA's 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 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:

[[Page 60626]]

    (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 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

[[Page 60627]]

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, 2002, 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, 2002, 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, 2002, focal spot 
condition shall be evaluated either by determining system resolution or 
by measuring focal spot dimensions. After October 28, 2002, 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 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.

[[Page 60628]]



                                                     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 mA's 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, 2002, 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.
    (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

[[Page 60629]]

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 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.

[[Page 60630]]

    (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 complaint 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:
    (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

[[Page 60631]]

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 assuring 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;
    (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.

[[Page 60632]]

    (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: November 3, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-29596 Filed 11-6-97; 1:07 pm]
BILLING CODE 4160-01-F