[Federal Register Volume 61, Number 65 (Wednesday, April 3, 1996)]
[Proposed Rules]
[Pages 14908-14920]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-7833]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 900
[Docket No. 95N-0195]
RIN 0910-AA24

Proposed Quality Standards for Mammography Equipment and Quality 
Assurance

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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[[Page 14909]]


SUMMARY: The Food and Drug Administration (FDA) is proposing to amend 
the regulations for facility standards established in the interim 
regulations implementing the Mammography Quality Standards Act of 1992 
(the MQSA). This proposed rule will establish additional performance 
standards for mammography equipment and equipment-related quality 
assurance practices currently required of mammography facilities. FDA 
is proposing these amendments based on advice from the National 
Mammography Quality Assurance Advisory Committee (NMQAAC), mammography 
equipment manufacturers, and public comments received in response to 
the interim regulations. This proposed rule is intended to assure safe, 
accurate, and reliable mammography on a nationwide basis. This document 
is the fifth of five related proposed rules that FDA is publishing 
concurrently in this issue of the Federal Register.

DATES: Written comments by July 2, 1996. The agency is proposing that 
any final rule based on this proposed rule become effective 1 year 
after its date of publication in the Federal Register, except where 
otherwise indicated.

ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, rm. 1-23, 12420 Parklawn Dr., 
Rockville, MD 20857. The Regulatory Impact Study (RIS) is available at 
the Dockets Management Branch for review between 9 a.m. and 4 p.m., 
Monday through Friday. Requests for copies of the RIS should be 
submitted to the Freedom of Information Staff (HFI-35), Food and Drug 
Administration, 5600 Fishers Lane, rm. 12A-16, Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Charles K. Showalter, Center for 
Devices and Radiological Health (HFZ-240), Food and Drug 
Administration, 1350 Piccard Dr., Rockville, MD 20850, 301-594-3332.

SUPPLEMENTARY INFORMATION:

I. Background

    This proposal is the fifth of five related proposed rules published 
in this issue of the Federal Register to amend interim regulations 
published on December 21, 1993 (58 FR 67558 and 58 FR 67565), 
implementing the MQSA (Pub. L. 102-539). The first proposed rule, 
``Quality Mammography Standards; General Preamble and Proposed 
Alternative Approaches'' contains background information and a summary 
of the preliminary analysis of the costs and benefits of the proposed 
rules, a description of the information collection requirements, 
proposed revisions to Sec. 900.1 Scope and Sec. 900.2 Definitions (21 
CFR 900.1 and 900.2), and proposed alternative approaches to 
mammography quality standards and a request for comments on the 
proposed alternatives.

II. Provisions of the Proposed Rule

A. Development of the Proposed Regulation

    As with the interim regulations, FDA was guided in the development 
of this proposed rule by the intent of the legislation to guarantee 
access to safe and effective mammography services for all women in the 
United States (Ref. 1). FDA also relied upon three major sources of 
information, in addition to the expertise and research of FDA 
personnel.
    First, the agency considered public comments received on the 
interim regulations. The agency received 103 comments from individuals 
and organizations, including: Professional organizations, medical 
facilities, State agencies, consumer groups, manufacturers, and 
individual physicians, medical physicists, and radiologic 
technologists. The proposed regulations were also discussed in a series 
of quarterly meetings with the NMQAAC. Members of the NMQAAC include 
interpreting physicians, medical physicists, radiologic technologists, 
representatives of State agencies, and consumer representatives. 
Consultants to the NMQAAC and guests invited to attend the committee 
meetings in recognition of their expertise in mammography also 
participated in these discussions of the proposed regulations. Finally, 
the agency obtained input through discussions with various professional 
and trade organizations and individuals with expertise related to 
mammography equipment, quality assurance, and infection control. 
Preliminary drafts of the proposed regulations were made generally 
available at the NMQAAC meetings and through notices of availability 
published in the Federal Register on December 30, 1994 (59 FR 67710) 
and January 26, 1995 (60 FR 5152).
    Organizations participating in discussions of the regulations 
included the National Electrical Manufacturers Association (NEMA), the 
Conference of Radiation Control Program Directors (CRCPD), and four 
national medical physicist organizations: The American Association of 
Physicists in Medicine, the American Academy of Health Physics, the 
American College of Medical Physicists, and the Health Physics Society.
    A discussion of the proposed amendments and a summary and analysis 
of NMQAAC input and public comments regarding the regulations is 
provided below.

 B. Equipment Regulations

    In Sec. 900.12(b) of the interim regulations, performance standards 
were established for equipment used in the production of mammograms. 
These standards were substantially harmonized with existing standards, 
such as those established by the Health Care Financing Administration 
(HCFA), the American College of Radiology (ACR), and some States. This 
interim approach was consistent with the legislative intent of the MQSA 
(Ref. 1) and enabled FDA to certify the thousands of facilities that 
already met voluntary accreditation standards prior to publication of 
the interim regulations. This approach also allowed the agency to 
concentrate its initial resources on facilities with no such prior 
accreditation. Now that additional input regarding the equipment 
standards has been obtained from the NMQAAC, equipment manufacturers, 
and the public, FDA is proposing additional requirements in 
Sec. 900.12(b) for radiographic, processing, and ancillary equipment 
used in mammography.
    In developing the proposed equipment standards, FDA recognized the 
need to balance the economic impact of new standards against the 
associated gains to the public health. It was also necessary for FDA to 
consider the availability (initially, and over time) of mammography 
equipment meeting the new requirements. This was necessary because, for 
some requirements, considerable time might be needed to allow for 
redesign, production, purchase, and installation of new equipment, or 
for retrofitting of the installed equipment base. The amount of time 
needed would depend on the nature of the requirement, the capacity of 
manufacturers, and the number of facilities already meeting the 
requirement. In consideration of these factors, the agency is proposing 
to phase in the equipment standards in proposed Sec. 900.12(b) over the 
next 1 to 10 years.
     In accordance with guidance from the NMQAAC, three effective dates 
are being proposed for different phases of implementation. Requirements 
to be implemented during the first phase would have an effective date 
of 1 year after the date of publication of the final rule. Such 
requirements would cover aspects of equipment performance that the 
NMQAAC considered fundamental to the delivery of quality mammography. 
Requirements to be

[[Page 14910]]
implemented during the second and third phases would have effective 
dates of 5 and 10 years after the date of publication of the final 
rule, which FDA estimates would correspond to approximately October 1, 
2000, and October 1, 2005, respectively. Although these dates have been 
used for the purpose of this proposal, the final effective dates will 
be modified to correspond to the dates 5 and 10 years after the 
publication date of the final rule. The agency believes that this 
advance guidance to the industry regarding upcoming changes in 
requirements and the phasing in of such requirements will minimize the 
economic impact of implementing improvements in mammography.
    Several comments received on the interim regulations indicated a 
lack of awareness of agency plans for notice-and-comment rulemaking in 
promulgating final regulations, or listed specific recommendations for 
changes or additions. Most of the recommendations for specific 
equipment requirements have been incorporated into the proposed 
standards. A summary of these comments and the FDA responses follow:
1. General
    One comment disagreed with the prohibition in the interim 
regulations against performance of mammography using a conventional x-
ray system with device modifications or options specifically designed 
to enable use of the system for mammography. The comment stated that 
allowing use of such systems for mammography would represent an 
economical source of equipment that should not be problematic as long 
as the systems can produce quality images without compromising examinee 
safety or dosage considerations.
    In response to this comment, FDA notes that the MQSA expressly 
states that equipment standards must ``require use of radiological 
equipment specifically designed for mammography'' (42 U.S.C. 
263b(f)(1)(B)). Therefore, FDA is continuing the prohibition against 
use of nonmammography x-ray equipment for the production of mammograms.
    One comment supported the interim requirements in Sec. 900.12 
(b)(2)(i) to (b)(2)(iii) but requested the addition of two subsections 
requiring: (1) Cassettes of appropriate size, to allow the technologist 
to obtain a complete breast image on a single film, and (2) grids 
specifically designed for mammography for each size of cassette.
    FDA agrees with these comments and has included such requirements 
in proposed Sec. 900.12(b)(4).
    Three comments suggested that the provision in 
Sec. 900.12(b)(2)(iii), requiring mammography equipment to have a 
removable grid, be expanded to require a reciprocating removable grid. 
A reciprocating (moving) grid would avoid grid lines often seen with a 
stationary grid. One comment did not understand the requirement in 
Sec. 900.12(b)(2)(iv), and in particular the phrase ``removable grid.'' 
The comment stated that, if the intent is not to reduce radiation dose, 
the appropriate word would be ``moving,'' rather than ``removable,'' 
because moving the grid improves image quality. Also, the comment 
questioned whether this standard refers to regular view or 
magnification mode.
    FDA believes that all equipment should be provided with 
reciprocating (moving) grids and that these grids should be removable 
for all systems providing magnification capability. These grid 
requirements have been proposed in Sec. 900.12 (b)(4)(ii) and 
(b)(4)(iii). The intent is that the grid be removable so that 
magnification procedures can be completed properly without increasing 
the radiation dose to the examinee.
    Discussions with the NMQAAC indicated considerable concern that 
radiographic equipment be equipped to enable a number of routine views 
for all examinees. Of specific concern were the mediolateral oblique, 
caudo-cranial, and cranio-caudal views, and the need to ensure that 
each facility has equipment that allows for variation in individual 
body habitus.
    Under Sec. 900.12(b)(3) (ii) and (iii), FDA has proposed specific 
requirements related to the motion capability of the gantry assembly 
that the NMQAAC believes will achieve this goal.
    The NMQAAC also strongly recommended that all mammography systems 
be required to have a light field that approximates the x-ray field and 
passes through the collimation system. This configuration would assist 
in positioning and allow visual verification that the radiographic view 
of the breast remains unobstructed. In response to this NMQAAC 
recommendation, FDA received comments from a major trade association 
representing manufacturers of mammography x-ray equipment indicating 
that a significant portion of the installed equipment base would not 
meet these requirements. This association further indicated that there 
may be significant costs associated with retrofitting existing 
equipment to comply with this recommendation.
    FDA is proposing to require in Sec. 900.12(b)(5) that all 
mammography systems have the light field recommended by the NMQAAC, 
effective October 1, 2000. FDA is requesting public comment on this 
proposed requirement and its likely impact on the cost and availability 
of mammography services.
    Proposed Sec. 900.12(b)(11)(i) references the requirements in 
Sec. 1020.30(m)(l) (21 CFR 1020.30(m)(1)) for minimum beam quality 
(half-value layer (HVL)) for mammography x-ray systems. FDA realizes 
that this reference is redundant with proposed Sec. 900.12(b)(2), but 
believes that it is necessary to clarify the requirements stated in 
proposed Sec. 900.12(b)(11)(i).
    One comment stated that, in addition to requiring the incorporation 
of a breast compression device, the regulation should mandate use of 
this device (at least for screening mammography), because compression 
enables better visualization of the breast and permits lower radiation 
dose to be used.
    FDA recognizes that use of a breast compression device is 
considered by professionals to be essential for proper imaging of the 
breast. By requiring that each system be equipped with a breast 
compression device, FDA has attempted to ensure that this feature is 
always available to the technologist. However, because the requirement 
that the compression device always be used would be extremely difficult 
to enforce, such a requirement has not been proposed.
    In Sec. 900.12(b)(12), FDA is proposing that all mammography 
systems be equipped with both foot-controlled power driven and fine 
adjustment controls (either manual or power driven). The intent of this 
requirement is to allow the technologist to use both hands to position 
the examinee under foot regulated power control, and to make final 
adjustments to the compression under the increased control provided by 
the fine adjustment mechanism. FDA is specifically requesting 
additional comments on this proposed requirement. For example, would a 
power-only system that provided a slower, more controlled, final 
application of power driven compression be as useful as a combination 
of power and manual compression?
    One comment suggested requiring that all compression equipment 
allow for automatic release of compression in case of power or 
mechanical failure.
    FDA recognizes that some facilities consider an automatic 
compression release desirable, and the proposed regulations permit 
this. However, under

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some conditions, an automatic release may represent a physical hazard 
to the examinee. Therefore, under Sec. 900.12(b)(12)(ii), FDA is 
proposing certain restrictions on systems that provide an automatic 
decompression feature.
    Two comments noted that the interim regulations do not require that 
the breast compression device be parallel to the imaging plane, thus 
potentially allowing unequal compression to occur.
    FDA agrees and the proposed regulations contain a requirement under 
Sec. 900.12(b)(12)(iii)(B) to address this concern. FDA notes, however, 
that there is one manufacturer that does not meet this proposed 
requirement because it claims that the nonparallel design of its device 
provides uniform compression. FDA requests comments (and supporting 
data) regarding whether the agency should: (1) Modify the proposed 
regulations to accommodate this alternative design, or (2) retain the 
requirement as proposed and allow manufacturers to obtain variances to 
market alternative devices, in accordance with the alternative 
equipment provision in proposed Sec. 900.18 (published elsewhere in 
this issue of the Federal Register).
    Seven comments recommended that FDA require automatic exposure 
control (AEC) capability on all systems. One comment suggested that the 
equipment requirements should be more specific to address phototimers, 
acceptable operating energies, radiation output, and milliampere (mA) 
requirements.
    FDA agrees and has included requirements for each of these areas in 
proposed Sec. 900.12 (b)(13), (b)(14), and (b)(15). These requirements 
were supported by the NMQAAC.
    One comment suggested that all mammography systems installed or 
transferred following implementation of the interim regulations should 
provide for milliampere second (mAs) readout following each exposure.
    FDA agrees that mAs readout is important and under proposed 
Sec. 900.12(b)(13)(iv), all equipment that automatically selects the 
mAs will be required to indicate the mAs value used following the 
exposure.
    Two comments suggested a number of technical requirements that all 
mammography equipment should be required to meet.
    The recommended requirements are supported by FDA and the NMQAAC 
and have been included in proposed Sec. 900.12 (b)(4), (b)(5), (b)(8), 
(b)(11), (b)(14), and (b)(15), or were already covered under the 
diagnostic x-ray system performance standard in Secs. 1020.30 and 
1020.31 (21 CFR 1020.31), with the exception of the following:
    (1) One comment suggested that a tungsten target tube should never 
be used for screen-film mammography.
    FDA disagrees with this comment. The agency believes there is no 
evidence to support prohibiting the use of tungsten target tubes and 
has not included this limitation in the proposed regulations.
    (2) One comment stated that the nominal focal spot size should be 
regulated in conjunction with the system source-image receptor distance 
(SID).
    FDA is proposing to address the issue of focal spot size through 
the proposed requirement for system resolution in Sec. 900.12(b)(8). 
The intent of this requirement (which has been adopted by the ACR), is 
to provide a test for system resolution that is easier to perform than 
a focal spot size determination.
    (3) One comment stated that the SID should not be less than 50 
centimeters (cm).
    FDA is proposing to adopt the ACR's minimum requirement for SID, 
which is 55 cm.
2. Xeromammography
    Three comments requested FDA to prohibit use of xeromammography, 
which the comments believed produces lower quality mammograms at a 
higher dose of radiation than screen-film modalities.
    FDA is aware of the controversy regarding use of xeromammography, 
but the agency believes that, with respect to certain diagnostic 
applications, the modality may still be equal to screen-film systems. 
At the same time, the virtual disappearance of xeromammography units 
from the marketplace indicates that the mammography community itself is 
discontinuing the general use of this modality. Both the interim and 
proposed regulations place a maximum limit on the dose that can be 
delivered to an examinee using xeromammography. In proposed 
Sec. 900.12(c), published elsewhere in this issue of the Federal 
Register, the dose that may be delivered by xeromammography has been 
reduced from the interim requirement of 4.0 milliGray (mGy) to 3.0 mGy. 
This decision was based on communication from the manufacturer of 
xeromammography systems informing FDA that properly adjusted and 
maintained xeromammography systems could meet such a requirement. Under 
the proposed regulations, therefore, the dose limits for screen-film 
and xeromammography would be the same.
    One comment questioned whether xeromammography will continue to be 
considered inadequate for screening purposes, in accordance with HCFA 
regulations.
    FDA regulations replace those issued by HCFA concerning mammography 
facilities and FDA regulations do not prohibit the use of 
xeromammography for screening.
3. Operator Protection
    Two comments expressed concern that no regulations addressed the 
protection of the operator by requiring radiation protective barriers 
or anchored exposure switches.
    FDA believes that specific operator safety requirements remain the 
responsibility of State and local authorities regulating the use of 
diagnostic x-ray equipment. Therefore, FDA has not proposed any 
requirements relating to this aspect of the facility operation.
4. Examinees With Disabilities
    In addition to meeting the specific requirements listed in this 
regulation, it was the opinion of the NMQAAC that each facility has the 
responsibility to accommodate examinees with physical disabilities and 
to provide such examinees with access to the same quality mammography 
provided to other examinees. The NMQAAC further believed that 
facilities that could not provide such special services should be 
required to screen prospective examinees during the appointment 
scheduling process and refrain from scheduling disabled examinees who 
cannot be accommodated.
    FDA has included a requirement in proposed Sec. 900.12(b)(16) 
reflecting this recommendation. The agency also encourages facilities 
that cannot accommodate disabled individuals to refer these individuals 
to a facility that is equipped to provide mammography services for 
them. FDA encourages comments regarding the necessity and 
appropriateness of this section in light of the requirements currently 
imposed by the Americans with Disabilities Act of 1990.
5. Interventional Mammography
    Five comments indicated that standards and test methods are needed 
for stereotactic units and dedicated biopsy-type machines.
    FDA agrees with these comments. However, the agency believes that 
no consensus exists in the mammography community regarding appropriate 
standards for such equipment and

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procedures. Various public and private organizations are working to 
develop such standards and FDA will propose requirements some time in 
the future.
6. International Harmonization
    In the Federal Register of November 28, 1994 (59 FR 60870), FDA 
published an agency policy on international harmonization of regulatory 
requirements. In accordance with that policy, the agency requests 
comments regarding the implications of the proposed equipment standards 
on any related international harmonization efforts for mammography 
equipment.

C. Quality Assurance (QA)--Equipment

    The primary purpose of the equipment aspects of the quality 
assurance program is to prevent problems with equipment or detect and 
correct problems before they can have a significant effect on clinical 
image quality. To achieve this, the performance parameters of the 
equipment must be tested at appropriate frequencies, the test results 
must be promptly analyzed to determine if the performance of the 
equipment is satisfactory, and any identified problems must be 
corrected as soon as possible. In addition, followup tests must be 
conducted to determine whether the corrective actions were effective. 
Requirements for these types of tests are proposed in Sec. 900.12(e).
1. Testing of Screen-Film Systems
    Proposed Sec. 900.12 (e)(1) through (e)(5) establish the minimum 
performance tests to be conducted on screen-film systems. The agency 
has decided not to propose extensive detailed requirements in order to 
provide facilities with the flexibility to use alternative methods that 
might be equally satisfactory or to add other tests. Under the interim 
regulations, FDA adopted the ACR's relatively detailed QA requirements 
(Ref. 2). However, the NMQAAC has advised FDA that these ACR 
requirements were intended to be used as guidelines, not in a 
prescriptive manner.
    Therefore, the agency is proposing to limit the quality assurance 
requirements for equipment to a more general listing of the required 
tests, establishment of the required test frequencies, definition of 
action limits, and, in some cases, specification of critical test 
conditions.
    At the July 1994 NMQAAC meeting, an additional daily total system 
test was discussed, which read as follows:
    Total System Test:
    (A) The optical density (OD) of the film at the center of an image 
of a uniform phantom when exposed in AEC mode shall not change by more 
than  0.20 from the established operating level. The OD of 
the established operating level shall be above 1.20. The mAs shall not 
change by more than 10 percent from the established value corresponding 
to the operating level OD.
    (B) The film shall be examined for system artifacts.
    The agency believes that this total system test, in conjunction 
with the processor performance test set forth in proposed 
Sec. 900.12(e)(1), should be performed daily before the first examinee 
is examined. The performance of these two tests will assure the overall 
quality of the x-ray machine, processor, and films. The records of the 
tests will also enable a medical physicist to quickly detect the source 
of a problem when it occurs. The above described system test takes only 
a few minutes to perform and can be performed by a quality control 
technologist.
    The NMQAAC suggested that more data about the usefulness of the 
total system test should be gathered before this test is introduced as 
a required daily test. The NMQAAC also agreed that the image quality 
evaluations described in proposed Sec. 900.12(e)(2) should be performed 
weekly if the total system test is not required.
    The agency is proposing system testing requirements in accordance 
with the NMQAAC's advice. Although FDA is not proposing to require the 
daily total system test at this time, the agency requests comments 
regarding the utility of this test. If the total system test were 
introduced, FDA would revise the regulations to require monthly, rather 
than weekly, performance of the image quality evaluations in proposed 
Sec. 900.12(e)(2).
    Several comments on the interim regulations raised concern about 
basing the quality control requirements on a single manual, such as the 
ACR manual (Refs. 2 and 3).
    In the proposed regulations, no manual has been referenced. A 
facility may consult any appropriate manual or rely on agency guidance 
to meet the requirements in proposed Sec. 900.12(e)(1) through (e)(5).
    One comment requested that any standard that is developed be 
achievable with current technology. As an example of a test that the 
comment believed could not be achieved using current technology, the 
comment cited ACR's criteria for passing the screen-film contact test, 
as described in the 1992 ACR manual (Ref. 2).
    The agency is convinced, based on the expertise of its staff and 
experience with the interim regulations, that the requirements and 
action limits proposed in this regulation can be met with current 
technology.
    One comment suggested that a minimum allowable dose should be 
specified for a 4.5-cm compressed breast composed of 50 percent 
glandular tissue and 50 percent adipose tissue. Also, one comment 
suggested that the mean glandular dose should not exceed 1.0 mGy for 
screen-film systems without grids.
    FDA believes that placing a lower limit on dose may hamper further 
technological advancement of systems that may reduce the dose without 
compromising image quality. In addition, the agency has decided to use 
only one upper dose limit for all systems.
    Several comments stated that FDA's data indicate that an accepted 
phantom simulates a 4.2-cm thick compressed breast, not 4.5 cm. 
Therefore, the regulations should use a 4.2-cm thickness. One comment 
stated that the dose should be determined using clinically employed 
technique factors for a 4.5-cm thick compressed breast composed of 50 
percent glandular tissue and 50 percent adipose tissue, instead of 
using the phantom technique factors promulgated in the interim 
regulations. Two comments noted that, in many cases, the technique 
factors used by a facility to produce phantom images do not reflect the 
technique factors actually used on examinees. This could result in 
examinees receiving doses exceeding the limits specified in the 
regulations, even though the facility technically passed the compliance 
test by using their phantom image technique factors. One comment stated 
that the dose should be determined under the facility's proposed 
technique factors for a 4.2-cm thick compressed 50 percent glandular/50 
percent adipose breast.
    After review of these comments, FDA is proposing to require 
clinical technique factors and a phantom simulating a 4.2-cm thick 
compressed 50 per cent glandular/50 per cent adipose tissue breast to 
be used during dose measurements. Although FDA has data to show that an 
accepted phantom simulates the attenuation properties of 4.2 cm of 50/
50 compressed breast tissue, the agency recently has developed 
additional data indicating that the phantom may be equivalent in 
attenuation properties to approximately 4.0-cm of 50/50 compressed 
breast tissue, as per the dose model used to convert skin exposure to 
dose. The agency, therefore, is soliciting more information and 
comments on the appropriate equivalent thickness of the phantom for 
dose calculation.

[[Page 14913]]

    One comment requested an explanation of the methods for obtaining 
FDA certification of QA phantoms. Another comment suggested that the 
regulations should specify one, and only one phantom, and should 
specify the minimum acceptable performance, rather than leaving this to 
the discretion of accreditation bodies.
    The agency continues to believe that accreditation bodies should 
establish phantom specifications and related performance criteria. 
However, as part of it responsibilities for accreditation body approval 
and oversight, FDA will examine each body's phantom specifications and 
performance requirements, which will have to be substantially the same 
among different accreditation bodies.
    One comment recommended that FDA publish some type of voluntary 
form(s) for maintaining appropriate records.
    FDA believes it is inadvisable for the agency to generate sample 
forms because such forms may be unnecessarily restrictive. Facilities 
that do not want to generate their own forms may adopt forms that are 
provided in various manuals, as appropriate.
2. Systems With Other Modalities
    Proposed Sec. 900.12(e)(6) would require that the facility quality 
assurance program for systems with image receptor modalities other than 
screen-film (e.g., xeromammography) be substantially the same as that 
recommended by the image receptor manufacturer. This section would also 
require that such systems meet the same dose limits as screen-film 
systems.
3. Mobile Units
    Proposed Sec. 900.12(e)(7) would establish additional quality 
assurance requirements for mobile mammography units. These mobile units 
are operated in a variety of environments and undergo the stress of 
frequent movements, often over rough surfaces. In view of this, a 
number of comments on the interim regulations urged FDA to require that 
a phantom image quality test be performed after every move, before any 
additional examinations are conducted at the new site. These comments 
stated that if a problem occurs after a move which could compromise the 
quality of clinical images, this problem should be detected and 
corrected before any further clinical use of the equipment. These 
comments believe this additional testing is necessary for mobile units 
in order to minimize the need for repeat examinations, which would 
result in additional radiation exposure and expense and might result in 
some cancers going undetected if it is not possible to get examinees to 
return to the facility.
    In contrast, other comments noted that a requirement for a post-
move, pre-examination image quality test would pose great difficulties 
to mobile services that are some distance from their home base and do 
not have access to adequate processing at the test site. These comments 
expressed concern that such a requirement would cause some mobile 
services to cease operation and would significantly reduce access to 
mammography in rural and inner city areas. Several comments cited their 
own experience in stating that image quality tests conducted after 
moves rarely or never show that a problem has occurred because of the 
move. The preliminary results of a survey of mobile facilities 
conducted by the ACR found that nearly 90 percent of the facilities 
rarely found problems after a move. However, the remaining facilities 
found problems as often as daily or weekly.
    The 1992 edition of the ACR QA manual (Ref. 2) recommended that an 
image quality test be conducted after every move, but was somewhat 
ambiguous regarding when the processing and analysis of the images 
should occur. However, the agency has been informed by members of the 
ACR committee who were responsible for the manual that they did not 
intend to require processing before further examinations were 
conducted. The 1994 edition of the ACR QA manual (Ref. 3) completely 
dropped the requirement for conducting image quality testing after 
every move. Under this revised ACR requirement, therefore, mobile units 
are required to undergo image quality testing at the same frequency as 
fixed units, which ordinarily is monthly.
    At its September 1994 meeting, the NMQAAC discussed this issue and 
recommended that post-move, pre-examination testing of mobile units be 
required in the final regulations. FDA agreed with this recommendation 
and has incorporated it in proposed Sec. 900.12(e)(7).
    The NMQAAC further recommended allowing use of a method of testing 
based on post-exposure mAs readout values in place of phantom image 
testing. FDA has decided not to require a particular method of testing 
at this time. Instead, the agency is proposing to require each facility 
to adopt a test method that will verify the adequacy of image quality 
following a move, but to leave the choice of test method to the 
facility. The agency believes that this approach will give individual 
facilities maximum flexibility. FDA will issue guidance documents that 
reflect the agency's current thinking about test methods that are 
appropriate. At this time, FDA expects those methods to include the 
method recommended by the NMQAAC as well as the traditional phantom 
image quality test.
    Including these methods of testing in guidance rather than in 
regulations has the advantage of increased speed and flexibility. As 
the agency becomes aware of new test methods of proven value, the 
agency's evaluation of such methods can be publicized through 
modification of guidance materials much more rapidly than through 
amendment of regulations. In addition, mobile units will have the 
option of using post-move pre- examination image quality test methods 
that are different from those described in guidance. Testing methods 
described in these materials will guide inspectors as they evaluate the 
adequacy of an individual facility's testing methods. Although the 
methods described in guidance will represent the agency's most current 
thinking about appropriate testing for this purpose, such guidance will 
not bind the facility or the agency. If a facility chooses alternative 
procedures, FDA encourages the facility to discuss the choice in 
advance in order to prevent expenditure of efforts and resources on 
testing that may later be determined to be unacceptable because it does 
not establish the adequacy of image quality following a move.
4. Use of Test Results
    Proposed Sec. 900.12(e)(8) describes how results from the tests 
specified in paragraphs (e)(1) through (e)(7) would be used to ensure 
that problems are detected and corrected before they adversely affect 
the quality of examinations.
5. Survey
    Proposed Sec. 900.12(e)(9) describes the activities that would have 
to be carried out by the medical physicist as part of the annual 
evaluation of facility equipment performance and quality assurance 
programs. A concern raised at the February 1994 NMQAAC meeting and 
elsewhere was that qualified medical physicists might delegate the 
onsite survey work to less qualified personnel and merely review and 
sign the survey report.
    Because FDA is also concerned about such delegation occurring, the 
agency is proposing in Sec. 900.12(e)(9)(i) that only qualified medical 
physicists be authorized to conduct the surveys. The agency is further 
proposing to require in Sec. 900.12(e)(9)(V) that the report be signed 
and dated by the individual who

[[Page 14914]]
performs the survey. As is the case with the signature of the 
interpreting physician on the mammography report (see discussion of 
Sec. 900.12(c)(1) published elsewhere in this issue of the Federal 
Register), the purpose of the signature requirement is to identify the 
individual who performed or provided direct supervision of the work. 
Therefore, in addition to handwritten signatures, FDA will accept 
``signatures'' that are generated from computer systems, typewritten, 
name stamped, and possibly provided in other ways. These requirements 
would not prohibit physicists-in-training from performing surveys to 
gain experience, but would require that such surveys be done under the 
direct supervision of a fully qualified medical physicist, who would 
have to sign the report as the responsible physicist. If another 
individual performs any part or all of the survey under the direct 
supervision of a medical physicist, that person and the part of the 
survey that person performed must also be identified on the survey 
report.
6. Mammography Equipment Evaluation
    Proposed Sec. 900.12(e)(10) would require a mammography equipment 
evaluation to be performed whenever a mammography unit or image 
processor is installed or major components of that unit or processor 
are changed. This requirement was added to ensure that the performance 
of new or significantly changed equipment is evaluated, and problems 
corrected, before such equipment is used during examinations. FDA 
believes mammography equipment evaluation, rather than a complete 
survey of the facility as described in Sec. 900.12(e)(9), is adequate 
for this purpose because not all aspects of the facility operation 
which are checked during a survey would be affected by the installation 
of new equipment or the modification of old equipment.
    The agency will describe its current thinking about appropriate 
procedures for carrying out these evaluations in guidance documents and 
will update that guidance, when warranted, to reflect scientific and 
professional developments. Similarly, the agency will describe in 
guidance its current thinking about appropriate qualifications for 
persons doing this work. As discussed previously with respect to agency 
guidance for testing mobile units, facilities will have the option of 
using procedures other than those described in guidance or employing 
individuals with qualifications different than those listed in 
guidance, assuming such alternative procedures or qualifications are 
adequate to examine equipment for such purposes. The guidance issued by 
FDA will not be binding on either the facility or the agency. Once 
again, however, FDA encourages facilities that choose alternative 
personnel or procedures, to discuss the choice in advance in order to 
prevent expenditure of efforts and resources on evaluations that may 
later be determined to be inadequate.
    FDA realizes that Sec. 900.12(e)(10), as presently proposed, raises 
the question as to what constitutes a ``major component'' of the 
equipment, i.e., what components would have a significant impact on the 
performance of the equipment if their repair or replacement were done 
improperly. The agency specifically requests comments on this issue.
7. Housekeeping and Maintenance Tasks
    At its July 1994 meeting, the NMQAAC stressed the importance of 
carrying out regular maintenance and housekeeping activities as well as 
properly storing film and processing chemicals. However, the agency 
decided, for two reasons, not to propose detailed and comprehensive 
requirements for such activities.
    First, failure to follow proper maintenance and housekeeping 
activities at a facility will be revealed through failure of the tests 
outlined in Sec. 900.12(e)(1) through (e)(6) and through adverse 
findings in the physicist's survey. Additional detailed requirements 
would be redundant.
    Second, there are a wide variety of effective maintenance and 
housekeeping activities. The agency believes that it would be overly 
prescriptive to limit facilities to one set of activities in this area 
by regulation.
    At its January 1995 meeting, the NMQAAC agreed that the details of 
these activities could be incorporated into guidance materials rather 
than regulatory requirements. However, the members believed that 
general requirements should be established for certain especially 
important activities. Therefore, FDA is proposing to require in 
Sec. 900.12(e)(11) that facilities establish and follow protocols for 
the maintenance of darkroom, screen, and view box cleanliness.
8. Calibration of Exposure Measuring Instruments
    In order to have reliable uniform dose measurements in facilities 
all across the United States, it is important to have proper 
traceability of the instruments used to measure x-ray exposure. The 
agency is proposing to add in Sec. 900.12(e)(12) a requirement for 
annual calibration of such instruments, which must be traceable to a 
national standard.
9. Infection Control
    Concern was expressed during the open public portion of several 
NMQAAC meetings and by one comment on the interim regulations that, 
because of the possibility of nipple discharge during mammography, FDA 
should mandate the use of universal precautions during all mammography 
examinations to protect examinees and health care workers from possible 
transmission of bloodborne pathogens. The comment also expressed 
concern that present procedures used to disinfect mammography equipment 
between examinations are inadequate to prevent disease transmission.
    FDA notes that the concept of ``universal precautions'' is an 
approach to infection control stipulating that all human blood and 
certain human body fluids should be treated as if known to be 
infectious for human immunodeficiency virus (HIV), hepatitis B and C 
viruses (HBV, HCV), and other bloodborne pathogens. The Occupational 
Safety and Health Administration (OSHA) already mandates the use of 
universal precautions for all situations where occupational exposure 
can reasonably be anticipated (29 CFR 1910.1030). Although staff at the 
Centers for Disease Control (CDC) have advised FDA that there have been 
no reported cases of transmission of HIV, HBV, or HCV to examinees or 
health care workers during mammography, such transmission is 
theoretically possible (if no infection control precautions are taken). 
Therefore, the OSHA regulations are applicable to the practice of 
mammography, and it would be redundant for FDA to issue a universal 
precautions requirement under the MQSA authority.
    With respect to appropriate decontamination practices, members of 
the NMQAAC noted during an advisory committee meeting that guidelines 
and regulations addressing infection control practices relevant to 
mammography are available from CDC (Ref. 4) and OSHA (29 CFR 
1910.1030(d)(4)). These guidelines and regulations specifically address 
the decontamination of medical equipment and working surfaces after 
contact with blood or other potentially infectious materials. Local 
infection control policies are also in effect in many locations.
    In addition, the Association for the Advancement of Medical 
Instrumentation (AAMI) recently published a technical information 
report on reprocessing of reusable medical

[[Page 14915]]
devices (Ref. 5). Several other national and international standards 
setting organizations are developing guidance in this area as well. 
However, these guidelines, regulations, reports, and standards do not 
completely cover all aspects of reprocessing mammography equipment, 
because they may not address the special concerns of disinfecting 
electrical equipment, and may not consider the effect of the 
disinfecting agent upon the equipment. For these reasons, FDA is 
developing a guidance document regarding labeling of reusable medical 
devices for reprocessing in health care facilities (Ref. 6). A notice 
of availability requesting comments on this guidance document was 
published in the Federal Register on June 15, 1995 (60 FR 31484). FDA 
and industry will utilize this document to ensure appropriate labeling 
for new devices as well as for improving labeling for currently 
marketed devices.
    FDA believes that the concern raised by the comment transcends the 
issue of reuse of mammography devices and addresses the broader general 
issue of safe reuse of any reusable medical device. Therefore, it is an 
issue to be resolved under the agency's general medical device 
authority, rather than under the authority of the MQSA. In light of the 
concerns raised, however, FDA is reviewing current guidance and 
regulations, as well as additional guidance under development by the 
agency, to determine whether new labeling information or accessories 
are necessary with respect to reuse of mammography devices. FDA 
encourages interested parties to communicate to the agency any concerns 
and proposed solutions in this area.
    To ensure that the practice of mammography benefits from infection 
control guidance already available, FDA is proposing to require that 
facilities establish, adhere to, and document their compliance with a 
system of infection control. In addition to requiring compliance with 
any applicable infection control regulations, each facility's system 
would have to require adherence to infection control recommendations 
provided by the manufacturer(s) of the mammography equipment used in 
the facility, or, if adequate manufacturer's recommendations are not 
available, adherence to generally accepted guidance on infection 
control (e.g., Refs. 4 and 5), until such recommendations become 
available.

III. Environmental Impact

    The agency has determined under 21 CFR 25.24(e)(3) that this action 
is of a type that does not individually or cumulatively have a 
significant effect on the human environment. Therefore, neither an 
environmental assessment nor an environmental impact statement is 
required.

IV. Analysis of Impacts

    FDA has examined together the impacts of this proposed rule and the 
proposed rules on accreditation bodies, general facility requirements, 
and personnel, published elsewhere in this issue of the Federal 
Register, under Executive Order 12866, the Regulatory Flexibility Act 
(Pub. L. 96-354), and under the Unfunded Mandates Reform Act. The 
analysis has addressed the proposed requirements of these four rules as 
one unit for purposes of determining their economic impact. The 
preamble to the proposed rule ``Quality Mammography Standards; General 
Preamble and Proposed Alternative Approaches,'' published elsewhere in 
this issue of the Federal Register, contains a brief summary of the 
cost and benefit determination and the Regulatory Impact Study that 
details the agency's calculation of these economic impacts and is 
available at the Dockets Management Branch (address above) for review. 
FDA recognized that these proposed regulations may have a 
disproportionate effect on small volume mammography facilities and is 
currently collecting additional information on the potential impact on 
this industry sector. The agency requests comments that will assist it 
in accounting for this impact.

V. Paperwork Reduction Act of 1995

    This proposed rule contains no information collection or 
recordkeeping requirements under the Paperwork Reduction Act of 1995.

VI. Comments

    Interested persons may, on or before July 2, 1996, submit to the 
Dockets Management Branch (address above) written comments regarding 
this proposal. Two copies of any comments are to be submitted, except 
that individuals may submit one copy. Comments are to be identified 
with the docket number found in brackets at the heading of this 
document. Information submitted in response to this notice may be seen 
in the office above between 9 a.m. and 4 p.m., Monday through Friday.

VII. References

    The following information has been placed on display in the Dockets 
Management Branch (address above) and may be seen by interested persons 
between 9 a.m. and 4 p.m., Monday through Friday:

    1. ``Report on the Mammography Quality Standards Act of 1992,'' 
U.S. Senate, Report 102-448, October 1, 1992.
    2. American College of Radiology, ``Mammography Quality Control: 
Radiologist's Manual, Radiologic Technologist's Manual, and Medical 
Physicist's Manual,'' February, 1992.
    3. American College of Radiology, ``Mammography Quality Control: 
Radiologist's Manual, Radiologic Technologist's Manual, and Medical 
Physicist's Manual,'' 1994.
    4. Centers for Disease Control, ``Recommendations for Prevention 
of HIV Transmission in Health-Care Settings,'' Morbidity and 
Mortality Weekly Report, 36(2S):3S-18S, 1987.
    5. AAMI TIR No. 12-1994, ``Designing, Testing, and Labeling 
Reusable Medical Devices for Reprocessing in Health Care Facilities: 
A Guide for Device Manufacturers,'' Association for the Advancement 
of Medical Instrumentation, 3330 Washington Blvd., suite 400, 
Arlington, VA 22201-4598, 1995.
    6. Food and Drug Administration, ``Labeling Reusable Medical 
Devices for Reprocessing in Health Care Facilities: FDA Reviewer 
Guidance,'' Rockville, MD, March, 1995.

List of Subjects in 21 CFR Part 900

    Electronic products, Health facilities, Mammography, Medical 
devices, Radiation protection, Reporting and recordkeeping 
requirements, X-rays.

    Therefore, under the Federal Food, Drug, and Cosmetic Act, the 
Public Health Service Act, and under authority delegated to the 
Commissioner of Food and Drugs, it is proposed that 21 CFR part 900 be 
amended to follows:

PART 900--MAMMOGRAPHY

    1. The authority citation for 21 CFR part 900 continues to read as 
follows:

    Authority: Secs. 519, 537, and 704(e) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 360i, 360nn, and 374(e)); sec. 354 of 
the Public Health Service Act (42 U.S.C. 263b).

    2. Section 900.12 is amended by revising paragraphs (b) and (e) to 
read as follows:


Sec. 900.12  Quality standards.

* * * * *
    (b) Equipment--(1) Prohibited equipment. Radiographic equipment 
designed for general purpose or special nonmammography procedures shall 
not be used for mammography. This 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 14916]]
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) Gantry assembly 
motion.
    (A) The gantry assembly shall be capable of being rigidly fixed in 
any position where it is designed to operate. Once fixed in any such 
position, the gantry shall not move without operator intervention.
    (B) The mechanism assuring compliance with paragraph (b)(2)(A) of 
this section shall not fail in the event of power interruption.
    (ii) Effective October 1, 2000, the gantry assembly shall allow 
continuous rotation of at least 180 deg. from vertical (cranio-caudal 
position) in one direction and of at least 105 deg. from vertical in 
the other direction.
    (iii) Effective October 1, 2005, the gantry assembly shall allow 
continuous rotation of at least 180 deg. from vertical (cranio-caudal 
position) in one direction and of at least 135 deg. from vertical in 
the other direction.
    (iv) Effective October 1, 2005, the system shall provide visual 
indication of the gantry angle to within  5 deg..
    (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.
    (iv) Grid motion shall not be impeded when a breast is subjected to 
compression during mammography. For each size of breast support device 
provided with the system, compliance shall be determined by applying 
compression to, and exposing, a 12-cm diameter acrylic disk, 1.5 cm-
thick, placed with its center located 4 cm in from the center of the 
chest wall edge of the breast support surface. A 4-cm thick homogeneous 
acrylic attenuator with rounded edges shall be located in the beam 
between the source and the compression paddle during the exposure. A 
film exposed at 28 kilovoltage peak (kVp) to obtain an optical density 
as close to 1.3 as possible shall be examined for grid-related 
artifacts. For equipment provided with automatic exposure control 
(AEC), the test shall be performed in the AEC mode. The compression to 
be applied during these tests shall be determined as follows:
    (A) Before October 1, 2000, for systems meeting the requirements in 
paragraph (b)(12)(i)(C) of this section, the maximum attainable power 
driven compression shall be used; and for systems not meeting the 
requirements in paragraph (b)(12)(i)(C) of this section, the 
compression applied shall be as close to 200 newtons (45 pounds) as 
possible, using manual compression or a combination of manual and power 
driven compression.
    (B) Effective October 1, 2000, the maximum attainable power-drive 
compression shall be used to determine compliance.
    (5) Beam limitation and light fields. (i) All systems shall have 
beam limitation devices that provide means to restrict the useful beam 
so that the x-ray field can be adjusted to extend beyond the chest wall 
edge of the image receptor.
    (ii) Any mammography system with a light field that passes through 
the beam-limiting device shall meet the following requirements:
    (A) The light field shall be aligned with the x-ray field so that 
the total 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 shall not exceed 2 percent of 
the distance from the source to the midpoint of the chest wall edge of 
the image receptor support device.
    (B) The light field shall provide an average illumination of not 
less than 160 lux (15 footcandles) at 100 cm or the maximum source-
image receptor distance (SID), whichever is less.
    (iii) Effective October 1, 2000, all mammography systems shall be 
equipped with light fields that pass through the beam-limiting device 
and approximate the x-ray field.
    (iv) Effective October 1, 2005, all systems shall be interlocked to 
prevent exposure unless appropriate combinations of beam limitation and 
image receptor size are selected.
    (v) Effective October 1, 2005, all systems shall be interlocked to 
prevent exposure with an x-ray field that extends beyond the nonchest 
wall edges of the image receptor support device.
    (6) Source-image receptor distance (SID). Effective October 1, 
2000:
    (i) Systems designed solely for contact mammography shall have a 
minimum SID of at least 55 cm.
    (ii) All systems shall provide visual indication of the selected 
SID to within 2 percent of its actual value.
    (7) Magnification. (i) Systems used for diagnostic procedures shall 
have magnification capability available for use by the operator at any 
time.
    (ii) Systems designed for magnification procedures shall provide at 
least one magnification setting within the range of 1.4 to 2.0.
    (8) System resolution. (i) The focal spot shall be such that, with 
the mammography screen-film combination used in the facility, the 
system will provide a minimum resolution of 11 line-pairs/mm when the 
high contrast resolution bar pattern is oriented with the bars 
perpendicular to the anode-cathode axis, and 13 line-pairs/mm when the 
bars are parallel to that axis.
    (ii) Effective October 1, 2005, for those systems providing 
magnification capability, a focal spot that meets the following 
requirements shall be provided:
    (A) The resolution provided by the magnification focal spot shall 
meet, at a minimum, the requirements of paragraph (b)(8)(i) of this 
section. Compliance shall be determined with the test pattern placed 
4.5 cm above the magnification breast support, under the conditions of 
system magnification providing a magnification factor as close to 1.5 
as can be achieved with the system.
    (B) When more than one target material is provided, the measurement 
in paragraph (b)(8)(ii)(A) of this section shall be made using the 
appropriate focal spot for each target material.
    (C) The grid shall be removed from the imaging chain during these 
measurements.
    (9) 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 is selected by the system algorithm, 
based on the exposure or a test exposure, the system shall display the 
target material selected after the exposure.
    (iv) When the selected target is related to the kVp, the system 
shall prevent exposure unless the correct combination of target and kVp 
is selected.
    (10) Focal spot location. (i) The focal spot shall be located so 
that the ray falling on the mid-point of the chest wall edge of the 
image receptor is within  5 deg. of perpendicular to the 
image receptor.
    (ii) Compliance shall be determined for each focal spot provided.
    (11) Filtration. (i) General. Each system shall comply with the 
beam quality requirements of Sec. 1020.30(m)(1)

[[Page 14917]]
of this chapter for the minimum half-value layer (HVL).
    (ii) Variable filtration. (A) Effective October 1, 2000, systems 
with variable filtration type or thickness shall be interlocked to 
prevent exposure if the selected filtration material is inappropriate 
for the target chosen or is outside the allowable range specified in 
paragraph (b)(11)(i) of this section.
    (B) If different types of filtration materials are available, the 
system shall display the type of filtration in use prior to exposure.
    (C) Effective October 1, 2000, if the filtration is automatically 
selected based on a test exposure, the system shall visually indicate 
the filtration that was actually used after the exposure is completed.
    (12) Compression. All mammography systems shall incorporate a 
compression device.
    (i) Application of compression. Effective October 1, 2000:
    (A) Power driven compression activated by foot controls operable 
from both sides of the examinee shall be provided.
    (B) Fine adjustment compression controls operable from both sides 
of the examinee shall be provided.
    (C) The compression device shall provide a maximum compression for 
the power drive between 111 newtons (25 pounds) and 200 newtons (45 
pounds).
    (ii) Decompression. (A) 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 also provide an 
override capability to allow maintenance of compression and shall 
continuously display the override status.
    (B) Each system shall provide a manual emergency compression 
release that can be activated in the event of power or automatic 
release failure.
    (C) If a system is equipped with a remote compression release 
control for the operator, the release control shall be located in a 
position that allows the operator to observe the examinee during 
activation of the release control.
    (iii) Compression paddle. (A) Systems shall be equipped with 
different sized compression paddles that match the sizes of all full-
sized image receptors provided. 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)(12)(iii)(B) and (b)(12)(iv)(A) of this section.
    (B) When compression is applied, 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. Compliance shall be determined by applying maximum 
system power compression to a 12-cm diameter acrylic disk 1.5-cm thick 
placed with its center located 4 cm in from the center of the chest 
wall edge of the breast support surface for each full size compression 
paddle provided. For systems without power driven compression, or for 
systems which, before October 1, 2000, do not meet the requirements in 
paragraph (b)(12)(i)(C), compliance shall be determined by applying 
compression at as close to 200 newtons (45 pounds) as achievable using 
manual or a combination of manual and power driven compression. 
Vertical measurements shall be made between the breast support surface 
and the compression paddle at each of the four corners of the image 
receptor and shall be compared to each other and to the 1.5-cm 
thickness of the test device. The maximum difference between any two 
values shall not exceed 1.0 cm.
    (C) The chest wall edge of the compression paddle shall be straight 
and parallel to the edge of the image receptor.
    (D) The chest wall edge should be bent upward, forming a lip to 
allow for examinee comfort, but shall not interfere with the image at 
the chest wall.
    (iv) Compression paddle alignment. (A) Effective October 1, 2000, 
when compression is applied, a line constructed perpendicular to the 
flat surface of the compression paddle through the vertex of the angle 
formed by the flat surface and the lip of the compression paddle and 
extending to the plane of the image receptor, shall intercept that plan 
within a distance no greater than  1 percent of the SID 
from the useful edge of the image receptor at the chest wall side (see 
Figure 1).

BILLING CODE 4160-01-P
[GRAPHIC] [TIFF OMITTED] TP03AP96.000

    (B) Effective October 1, 2005, when compression is applied, a line 
constructed perpendicular to the flat surface of the compression paddle 
through the vertex of the angle formed by the flat surface and the lip 
of the compression paddle and extending to the plane of the image 
receptor, shall pass within 2 millimeters of the useful

[[Page 14918]]
edge of the image receptor at the chest wall side.
    (C) When the system is configured without magnification capability, 
compliance shall be determined with the bottom surface of the 
compression paddle placed at a distance within the range of 2.0 to 6.0 
cm above the breast support.
    (D) When the system is configured for magnification procedures, 
compliance shall be determined with the bottom surface of the 
compression paddle placed at a distance within the range of 2.0 to 6.0 
cm above the breast support of the magnification device.
    (v) Display of compressed breast thickness. Effective October 1, 
2005, the compressed breast thickness shall be displayed and visible to 
the operator during positioning.
    (A) The compressed breast thickness shall be displayed to within 
0.5 cm.
    (B) Compliance shall be determined at the maximum attainable power 
compression using a flat sheet of rigid material with known thickness 
placed between the examinee support and the compression device. This 
sheet shall be placed in flat contact with the top surface of the 
breast support. If the support is uneven or has projections around the 
edges, the sheet shall be in contact with that part of the surface that 
actually supports the breast. This test shall be performed using sheets 
of the following thicknesses: 3 cm, 4.5 cm, and 6 cm.
    (13) Technique factor selection and display. (i) Manual selection 
of milliampere seconds (mAs) shall be available.
    (ii) All technique factors shall be clearly displayed at the 
control panel prior to exposure.
    (iii) When operating in AEC mode, the system shall indicate initial 
technique factors prior to exposure.
    (iv) Following AEC mode use, the system shall indicate the actual 
kVp and mAs used during the exposure.
    (v) All indications of kVp shall be within 5 percent of 
the actual kVp.
    (vi) Effective October 1, 2005:
    (A) Each system shall provide, at a minimum, for the selection of 
tube potentials of between 22 and 34 kVp.
    (B) Selection of kVp shall be available in increments no greater 
than 1 kilovolt each over the entire range provided.
    (C) Adjacent mAs settings shall differ by no more than 26 percent 
of the lower of the adjacent settings.
    (D) Combinations of exposure time and tube current (mAs) shall be 
available over the range of at least 5 mAs to 300 mAs.
    (14) Radiation output. (i) The system shall be capable of producing 
a minimum output of 1.29 x 10-4 coulomb/kilogram (C/kg) per second 
(500 milliroentgen (mR) per second) when operating at 28 kVp in the 
standard mammography mode at any SID where the system is designed to 
operate. Effective October 1, 2000, the system shall be capable of 
producing a minimum output of 2.06 x 10-4 C/kg per second (800 mR 
per second) when operating at 28 kVp in the standard mammography mode 
at any SID where the system is designed to operate.
    (ii) The system shall be capable of maintaining the required 
minimum radiation output for at least 3.0 seconds.
    (iii) Compliance shall be determined with the center of the 
detector located 4.5 cm above the breast support device used for 
contact mammography and centered on the breast support 4 cm in from the 
chest wall edge of the support with the compression paddle in place 
between the source and the detector.
    (15) Automatic exposure control. (i) Each system shall provide an 
AEC mode which is operable in all combinations of equipment 
configuration provided, i.e. grid, nongrid; magnification, 
nonmagnification; and various target-filter combinations.
    (ii) The AEC shall be capable of providing automatic mAs selection.
    (iii) The AEC shall provide reproducible radiation exposures with a 
coefficient of variation not to exceed 0.05.
    (iv) The positioning or selection of the active 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 input surface of the breast compression 
paddle.
    (B) The selected position of the detector shall be clearly 
indicated and visible from both sides of the examinee.
    (v) The system shall provide means for the operator to vary the 
selected optical density from the normal (zero) setting.
    (vi) Effective October 1, 2005, the system shall provide means for 
the operator to vary the optical density a minimum of 4 steps above and 
4 steps below the normal (zero) setting of optical density. These steps 
shall vary in optical density increments of between 10 to 20 percent of 
the difference between adjacent mAs settings;
    (vii) The system shall meet, at a minimum, the following 
requirements at all detector positions and for thicknesses of 2, 4, and 
6 cm of homogeneous breast tissue-equivalent material. Compliance shall 
be determined using the screen-film and processing combination used at 
the facility when the mean optical density is at least 1.20.
    (A) Effective October 1, 2000, equipment shall produce images with 
optical densities that vary from the mean optical density by no more 
than 0.30.
    (B) Effective October 1, 2005, equipment shall produce images with 
optical density that varies from the mean optical density by no more 
than 0.15.
    (16) Disabled examinees. Each facility scheduling disabled 
individuals shall have equipment and established protocols to ensure 
the facility's capability to perform mammography adequately on such 
individuals.
    (17) X-ray film. The facility shall use x-ray film for mammography 
that has been designated by the film manufacturer as appropriate for 
mammography.
    (18) Intensifying screens. The facility shall use intensifying 
screens for mammography that have been designated by the screen 
manufacturer as appropriate for mammography and shall match them to the 
spectral sensitivity specified by the manufacturer of the film used.
    (19) Film processing solutions. For processing mammography films, 
the facility shall use chemical solutions that are capable of 
developing the films used in a manner equivalent to the minimum 
requirements specified by the film manufacturer.
    (20) Lighting. The facility shall provide a special light with 
variable luminance capable of producing light levels greater than that 
provided by the view box.
    (21) Film Masking Devices. (i) All facilities shall have film 
masking devices that can limit the illuminated area to a region equal 
to or smaller than the exposed portion of the film.
    (ii) Facilities using x-ray collimation that provides 
nonrectangular exposed areas on the film shall provide masking devices 
appropriate to these fields.
    (iii) Facilities shall make devices meeting the requirements of 
paragraphs (b)(21)(i) and (b)(21)(ii) of this section available to the 
interpreting physician.
    (22) Film processors. Film processors used to develop mammograms 
shall meet the following requirements:
    (i) The processor shall be adjusted and maintained to meet the 
technical development specifications for the mammography film in use.
    (ii) Effective October 1, 2000, the processor shall indicate the 
selected time cycle reflecting the time from leading edge entry into 
the developer to leading edge entry into the fixer.

[[Page 14919]]

    (iii) Effective October 1, 2000, the processor shall be capable of 
maintaining the developer temperature to within 0.3 deg. 
Celsius (0.5  deg.F). Compliance measurements for immersion 
tank type processors shall be taken at the center of the surface of the 
developer solution and 7.5 cm (3 inches) below the surface when the 
developer is at the proper operating level.
    (iv) Effective October 1, 2005, the processor shall clearly display 
the actual developer temperature to within 0.1  deg.C 
(0.2  deg.F) of the actual temperature.
    (v) Effective October 1, 2005, for processors with variable cycles, 
the selectable parameters shall be interlocked to prevent any 
initiation of changes in the parameters until any film in process is 
completed, and to prevent any new film from entering the process cycle 
until the variables are properly stabilized at the new cycle 
parameters. If the unit is equipped with an override of this interlock 
for maintenance procedures, the override status shall be clearly 
indicated to the operator.
* * * * *
    (e) Quality assurance--equipment--(1) Daily quality control tests. 
Facilities with screen-film systems shall perform a processor 
performance test on each day that examinations are performed before any 
examinations are performed 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 of no less than 1.20 optical density (OD).
    (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 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 
acceptable to FDA in accordance with Sec. 900.3(d) or Sec. 900.4(a)(9).
    (iv) The image contrast between the background of the phantom and 
an added test object, used to assess density difference, 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 and any corrective actions and their results shall 
be recorded.
    (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. If the darkroom has a safelight, it shall be on during 
this test.
    (ii) Screen-film contact. Testing for screen-film contact shall be 
conducted using 40 mesh screen.
    (iii) Compression. The compression device shall meet the 
specifications described in Sec. 900.12(b)(12).
    (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 phantom thickness is varied over a range 
of 2 to 6 cm and the kVp is varied over the kVp range used in the 
facility for such thicknesses.
    (B) The operating optical density of the film in the center of the 
phantom image shall not be less than 1.20.
    (C) If the requirement of paragraph (e)(5)(i)(A) of this section 
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.
    (ii) Kilovoltage peak (kVp) accuracy and reproducibility.
    (A) At the lowest and highest clinical values and at any other 
commonly used clinical settings of kVp, the kVp shall be accurate to 
within  10 percent, 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) System Resolution. The limiting spatial resolution shall not 
be less than 13 line-pairs/mm parallel to the anode-cathode axis of the 
x-ray tube and 11 line-pairs/mm perpendicular to the anode-cathode 
axis.
    (iv) Beam quality and half-value layer (HVL). The HVL shall meet 
the specifications in paragraph (b)(11) of this section.
    (v) Breast entrance exposure and AEC reproducibility. The 
coefficient of variation for both exposure and mAs shall not exceed 
0.05.
    (vi) Dosimetry. The average glandular dose delivered during a 
single cranio-caudal view of an FDA-accepted phantom simulating a 4.2-
cm thick, compressed breast consisting of 50 percent glandular and 50 
percent adipose tissue, shall not exceed 3.0 milliGray (0.3 rad) per 
exposure. The dose shall be determined with technique factors and 
conditions used clinically for a 4.2-cm, 50 percent glandular/50 
percent adipose tissue compressed breast.
    (vii) X-ray field/light field/image receptor/compression paddle 
alignment. The x-ray field/light field/image receptor alignment shall 
meet the specifications of paragraph (b)(5) of this section and 
Sec. 1020.31(f)(3) of this chapter. In addition, the chest wall edge of 
the compression paddle shall not extend beyond the chest wall edge of 
the image receptor by more than one per cent of the SID.
    (viii) Screen speed uniformity. Screen speed uniformity 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 phantom large enough to cover the mammography 
cassette.
     (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.

[[Page 14920]]

    (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 additional 
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 non screen-film modalities, to the 
manufacturer's recommended action limits; or, for post-move, pre-
examination testing of mobile units, to the limits established in the 
test method used by the facility. The applicable tests shall be 
repeated immediately for any parameters found to be beyond the 
specified acceptable ranges.
    (ii) If the repeated tests continue to produce unacceptable 
results, the source of the problem shall be identified and corrective 
actions shall be taken before any further examinations are performed.
    (9) Surveys. (i) At a frequency of no less than 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 in paragraphs (e)(5) and (e)(6) of this section and the 
weekly phantom image quality test 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, or major components of a mammography 
unit or processor equipment are changed. 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. The mammography 
equipment evaluation shall be performed by an individual whose 
qualifications are adequate to examine equipment for this purpose and 
in accordance with procedures that are adequate to ensure that the 
examination is complete and accurate.
    (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 exposure measuring instruments. (i) Instruments 
used to measure the exposure or exposure rate from a mammography unit 
shall be traceable to a national standard.
    (ii) Effective October 1, 2005, the manufacturers calibrating 
instruments to measure exposure or exposure rate from mammography units 
shall meet the requirements of a recognized quality assurance program. 
A calibration laboratory calibrating instruments to measure exposure or 
exposure rate from mammography units must be accredited by a recognized 
national program or an equivalent international program which requires 
continuing participation with NIST in measurements and testing for 
maintaining quality assurance appropriate for mammography.
    (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.

    Dated: March 22, 1996.
David A. Kessler,
Commissioner of Food and Drugs.
Donna E. Shalala,
Secretary of Health and Human Services.
[FR Doc. 96-7833 Filed 3-29-96; 8:45 am]
BILLING CODE 4160-01-P