[Federal Register Volume 64, Number 71 (Wednesday, April 14, 1999)]
[Rules and Regulations]
[Pages 18331-18333]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-9222]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 900

[Docket No. 98N-0728]


 Quality Mammography Standards

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending its 
regulations governing mammography. The purpose of these amendments is 
to eliminate a conflict between the mammography regulations, which must 
be followed by all facilities performing mammography, and FDA's 
electronic product radiation control (EPRC) performance standards, 
which establish radiation safety performance requirements for x-ray 
units, including mammographic systems.

DATES: This regulation is effective on April 28, 1999.

FOR FURTHER INFORMATION CONTACT: Roger L. Burkhart, 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

     The Mammography Quality Standards Act (MQSA) (Pub. L. 102-539) was 
signed on October 27, 1992, to establish national quality standards for 
mammography. The MQSA required that to provide mammography services 
legally after October 1, 1994, all facilities, except facilities of the 
Department of Veterans Affairs, had to be accredited by an approved 
accreditation body and certified by the Secretary of Health and Human 
Services (the Secretary). The authority to approve accreditation bodies 
and to certify facilities was delegated by the Secretary to FDA.
     A specific requirement of MQSA was that quality standards be 
established for mammographic equipment and practices, including quality 
assurance and quality control programs. Mammography facilities had to 
meet these standards to become accredited and certified. The standards 
were intended to replace the patchwork of Federal, State, and private 
standards existing in 1992 to ensure that all women nationwide receive 
uniformly high quality mammography services. Since October 1, 1994, 
these standards have been provided by interim rules published in the 
Federal Register of December 21, 1993 (58 FR 67558 and 58 FR 67565), 
and amended in the Federal Register of September 30, 1994 (59 FR 
49808).
     In the Federal Register of April 3, 1996 (61 FR 14856, 61 FR 
14870, 61 FR 14884, 61 FR 14898, and 61 FR 14908), FDA proposed 
regulations to replace the interim regulations. Developed with strong 
congressional encouragement, these proposed regulations reflected FDA's 
belief that more comprehensive quality standards would further optimize 
facility performance. After analysis of the extensive public comments 
received on the proposed regulations, revisions were made and a final 
rule was published in the Federal Register of October 28, 1997 (62 FR 
55852). The effective date for most of the final rule is April 28, 
1999. A few equipment and equipment quality assurance requirements do 
not become effective until October 28, 2002.
     FDA has subsequently discovered that some mammographic x-ray 
systems will have difficulty meeting certain of the new requirements 
because of design features that were used by the manufacturers in order 
to ensure that their units met the agency's EPRC performance standards 
for diagnostic x-ray systems. To resolve this conflict, proposed 
amendments to the MQSA regulations were published in the

[[Page 18332]]

Federal Register of November 5, 1998 (63 FR 59750).

 II. Need for Amendments

     The source of the conflict lies in the requirements for the 
collimation of the x-ray field and the alignment of that field with the 
image receptor found in Sec. 900.12(b)(5) and (e)(5)(vii) (21 CFR 
900.12(b)(5) and (e)(5)(vii)) of the MQSA final regulations. Two 
problems exist with these provisions as they appeared in the October 
28, 1997, publication.
     First, both of these provisions permit the x-ray field ``to extend 
to or beyond the edges of the image receptor.'' This allowance was made 
in response to the expressed desire of some mammography facilities to 
have the capacity to ``blacken'' the film to the edges, a capacity that 
is particularly useful when automated viewing devices are used. 
However, the manufacturers of all diagnostic x-ray systems, including 
mammography systems, must comply with applicable performance standards 
established by FDA. These performance standards currently require that 
mammography systems be manufactured with collimation to ensure that the 
x-ray field does not extend beyond the nonchest wall edges of the image 
receptor.
     It is possible for a mammography system to meet both of these sets 
of standards as they were originally written. However, FDA has been 
informed by several manufacturers that in the past, in order to be sure 
to meet the EPRC standards, their systems were designed so that the x-
ray field does not reach the nonchest wall edges of the image receptor. 
Such systems would not meet the final MQSA regulations as presently 
written.
     Without an amendment to the MQSA regulations, in order to be in 
compliance, some facilities would have to choose among three courses of 
action. The first would be to apply for and receive approval of an 
alternative requirement for alignment under 21 CFR 900.18 of the MQSA 
regulations that would allow the facility to continue using its system 
unchanged. The second would be to purchase a retrofit of their system 
under a variance to the performance standards that has already been 
approved by FDA for one manufacturer. The third would be to purchase a 
new system that meets both sets of existing requirements.
     FDA proposed solving this first problem by amending 
Sec. 900.12(e)(5)(vii) so that the x-ray field will be allowed, but not 
required as at present, to extend to or beyond the nonchest wall sides 
of the image receptor. This would permit facilities whose systems are 
not presently capable of ``blackening'' the films to these edges to 
continue to use those systems without the need of either applying for 
an alternative requirement or purchasing an expensive retrofit or new 
unit.
     The second problem is that the limit on the extension of the x-ray 
field beyond all edges of the image receptor to ``within 2 percent of 
the SID'', discussed on page 62 FR 55852 at 55945 of the preamble of 
the October 27, 1997, final rule, was erroneously applied in the 
regulations only to the chest wall side of the image receptor. This 
omission raises the possibility of an unnecessary radiation hazard to 
the patient if the x-ray field extends an excessive amount beyond the 
nonchest wall edges of the image receptor. The agency proposed to 
remove this radiation hazard concern by amending Sec. 900.12(e)(5)(vii) 
to apply the 2 percent of the SID extension limit to all edges of the 
image receptor, in accordance with the intentions expressed in the 
preamble.
     Finally, FDA proposed to simplify the regulations by dropping all 
mention of alignment from Sec. 900.12(b)(5), thus consolidating all 
alignment requirements at one location in Sec. 900.12(e)(5)(vii). The 
portion of Sec. 900.12(b)(5) dealing with the light field remains 
unchanged.

 III. Comments on the Proposed Amendments

     FDA invited interested persons to comment on the November 5, 1998, 
proposed rule by January 4, 1999. FDA received two comments. One 
comment from a professional organization supported the amendments, 
noting that they would ``eliminate conflict'' between the two sets of 
regulations, ``address user concerns,'' and take into account ``cost 
concerns'' of facilities. The second comment, from a State radiation 
control agency, simply expressed support for the amendments. In view of 
these responses, the agency has decided to make the amendments final.

 IV. Environmental Impact

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

 V. Analysis of Impacts

     FDA has examined the impacts of this rule under Executive Order 
12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612) (as amended 
by subtitle D of the Small Business Regulatory Fairness Act of 1996 
(Pub. L. 104-121)), and the Unfunded Mandates Reform Act of 1995 (Pub. 
L. 104-4). Executive Order 12866 directs agencies to assess all costs 
and benefits of available regulatory alternatives and, when regulation 
is necessary, to select regulatory approaches that maximize net 
benefits (including potential economic, environmental, public health 
and safety, and other advantages; distributive impacts; and equity). 
The agency believes that this rule is consistent with the regulatory 
philosophy and principles identified in the Executive Order. In 
addition, this rule is not a significant regulatory action as defined 
by the Executive Order and so is not subject to review under the 
Executive Order.
     The Regulatory Flexibility Act requires agencies to analyze 
regulatory options that would minimize any significant impact of a rule 
on small entities. The agency certifies that this final rule will not 
have a significant negative economic impact on a substantial number of 
small entities. This rule also does not trigger the requirement for a 
written statement under section 202(a) of the Unfunded Mandates Reform 
Act because it does not impose a mandate that results in an expenditure 
of $100 million or more by State, local, or tribal governments in the 
aggregate, or by the private sector, in any one year.
     FDA had previously estimated (62 FR 55852 at 55968) that the 
expected average annual benefits from the final regulations would range 
between $181.7 million and $262.7 million. Average annual compliance 
costs were estimated at $38.2 million. The compliance cost estimate did 
not include the possible added costs related to the alignment 
requirement discussed previously, as the difficulty noted by the 
manufacturers was not foreseen during the development of the 
regulations. These added costs would be minimal if an alternative 
requirement was applied for and received but would be more significant 
if retrofitting or purchase of a new unit was carried out to meet the 
requirement. However, FDA's amending of the regulations will eliminate 
the requirement leading to the possible extra costs and thus eliminate 
any possible extra cost.

[[Page 18333]]

 VI. Paperwork Reduction Act of 1995

     The agency has determined that this final rule contains no 
additional collections of information. Therefore, clearance by the 
Office of Management and Budget under the Paperwork Reduction Act of 
1995 is not required.

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, and 
under authority delegated to the Commissioner of Food and Drugs, 21 CFR 
part 900 is amended as follows:

PART 900--MAMMOGRAPHY

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

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

     2. Section 900.12 is amended by revising paragraphs (b)(5) and 
(e)(5)(vii)(A) to read as follows:


Sec. 900.12   Quality standards.

* * * * *
     (b) * * *
     (5)  Light fields. 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.
* * * * *
     (e) * * *
     (5) * * *
     (vii) * * *
     (A) All systems shall have beam-limiting devices that allow the 
entire chest wall edge of the x-ray field to extend to the chest wall 
edge of the image receptor and provide means to assure that the x-ray 
field does not extend beyond any edge of the image receptor by more 
than 2 percent of the SID.
* * * * *

    Dated: April 7, 1999.
William K. Hubbard,
Acting Deputy Commissioner for Policy.
[FR Doc. 99-9222 Filed 4-13-99; 8:45 am]
BILLING CODE 4160-01-F