[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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