Notice2024-19058
Withdrawal of Approval and Amending of Mammography Quality Standards Act Alternative Standards
Primary source
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Published
August 26, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or the Agency) is announcing the withdrawal of two Mammography Quality Standards Act (MQSA) Alternative Standards and the amending of one Alternative Standard due to the updated MQSA regulations.
Full Text
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<title>Federal Register, Volume 89 Issue 165 (Monday, August 26, 2024)</title>
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[Federal Register Volume 89, Number 165 (Monday, August 26, 2024)]
[Notices]
[Pages 68446-68447]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-19058]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0134]
Withdrawal of Approval and Amending of Mammography Quality
Standards Act Alternative Standards
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of withdrawal.
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SUMMARY: The Food and Drug Administration (FDA or the Agency) is
announcing the withdrawal of two Mammography Quality Standards Act
(MQSA) Alternative Standards and the amending of one Alternative
Standard due to the updated MQSA regulations.
DATES: The relevant Alternative Standards will be withdrawn or amended
as of September 10, 2024.
FOR FURTHER INFORMATION CONTACT: Preetham Sudhaker, Division of
Mammography Quality Standards (DMQS), Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Silver Spring, MD 20993, 301-796-5911.
SUPPLEMENTARY INFORMATION:
I. Background
On March 10, 2023, FDA issued a final rule (88 FR 15126) to update
the mammography regulations that were issued under the Mammography
Quality Standards Act of 1992 and the Federal Food, Drug, and Cosmetic
Act. The final rule amending Sec. Sec. 900.1 through 900.25 (21 CFR
900.1 through 900.25) will become effective September 10, 2024. Based
on FDA's determination that withdrawing and amending several MQSA
Alternative Standards is justified by Sec. 900.12 (as amended in that
final rule), in accordance with Sec. 900.18, FDA is withdrawing
approval of and amending those alternatives.
II. Withdrawal of Approval and Amendment of Alternative Standards
As of September 10, 2024, FDA is withdrawing approval of MQSA
Alternative Standards #11 ``Modifications in the Assessment Categories
Used in Medical Reports'' (<a href="https://www.fda.gov/radiation-emitting-products/regulations-mqsa/mqsa-alternative-standard-11-modifications-assessment-categories-used-medical-reports">https://www.fda.gov/radiation-emitting-products/regulations-mqsa/mqsa-alternative-standard-11-modifications-assessment-categories-used-medical-reports</a>) and #12 ``Assessment
category for `Post Procedure Mammograms for Marker Placement' ''
(<a href="https://www.fda.gov/radiation-emitting-products/regulations-mqsa/mqsa-alternative-standard-12-assessment-category-post-procedure-mammograms-marker-placement">https://www.fda.gov/radiation-emitting-products/regulations-mqsa/mqsa-alternative-standard-12-assessment-category-post-procedure-mammograms-marker-placement</a>). FDA is also amending the Alternative Standard #8
``Separate Assessment for Findings for Each Breast'' (<a href="https://www.fda.gov/radiation-emitting-products/regulations-mqsa/mqsa-alternative-standard-8-separate-assessment-findings-each-breast">https://www.fda.gov/radiation-emitting-products/regulations-mqsa/mqsa-alternative-standard-8-separate-assessment-findings-each-breast</a>).
FDA may approve an alternative to a quality standard under Sec.
900.12 when the Agency determines that the proposed alternative
standard is at least as effective in assuring quality mammography as
the standard it proposes to replace, and is too limited in
applicability to justify amending the standard, or when the expected
benefit to human health is so great that the time needed to amend the
standard presents an unjustifiable risk to human health. See Sec.
900.18. Under Sec. 900.18(g), FDA shall amend or withdraw approval of
an alternative standard whenever the Agency determines that such action
is necessary to protect the human health or where otherwise justified
by Sec. 900.12. For the reasons discussed below, FDA has determined
that withdrawing and/or amending the Alternative Standards is justified
by Sec. 900.12.
FDA has determined that withdrawing Alternative Standard #11 is
justified by Sec. 900.12. Alternative Standard #11 provided an
alternative standard to Sec. 900.12(c)(1)(iv) and (v), which provides
the categories of overall assessment of findings for use in the reports
of mammography examinations. Specifically, the approved alternative
allowed use of: (1) an additional assessment category (``Known Biopsy-
Proven Malignancy''), (2) a reference to the possible need to obtain
prior mammograms to make a final assessment for the ``Incomplete''
assessment category, and (3) certain clarifying language to various
existing assessment categories (e.g., ``Benign Finding(s),''
``Suspicious Abnormality'' (emphases added)).
Amended Sec. 900.12(c)(1)(iv) includes the additional assessment
category ``Known Biopsy-Proven Malignancy'' and amended Sec.
900.12(c)(1)(v) includes a new provision that addresses the potential
need for prior mammograms for comparison for ``Incomplete''
assessments. Specifically, the amended Sec. 900.12(c)(1)(v)(A) and (B)
provides different requirements depending on whether facilities use the
assessment category of ``Incomplete: Need additional imaging
evaluation'' or ``Incomplete: Need prior mammograms for comparison.''
Alternative Standard #11, however, groups these two assessment
categories into a single
[[Page 68447]]
assessment category: ``Incomplete: Need additional imaging evaluation
and/or prior mammograms for comparison.'' As such, it is not clear how
a facility would comply with both the Alternative Standard and the
other applicable requirements in the amended regulations.
Moreover, as discussed in the MQSA small entity compliance guide,
FDA has generally exercised enforcement discretion regarding the final
assessment category wording where the variation in wording does not
change the meaning of the assessment category (e.g., ``benign finding''
instead of ``benign'' or ``suspicious abnormality'' instead of
``suspicious''), and FDA intends to continue such a practice. Thus, FDA
has determined that Alternative Standard #11 is no longer needed, no
longer appropriate, and may cause confusion, and so withdrawal of
Alternative Standard #11 is justified by Sec. 900.12.
FDA also has determined that withdrawal of Alternative Standard #12
is justified by Sec. 900.12. Alternative Standard #12 allowed use of
an additional assessment category ``Post Procedure Mammograms for
Marker Placement.'' As of the effective date of the MQSA final rule
(September 10, 2024), the nearly identical assessment statement ``Post-
Procedure Mammogram for Marker Placement'' is included in the amended
Sec. 900.12(c)(1)(iv)(G). Because amended Sec. 900.12(c)(1)(iv)(G)
incorporates Alternative Standard #12, FDA has determined that the
alternative is no longer needed, no longer appropriate, and may cause
confusion, and so withdrawal of Alternative Standard #12 is justified
by Sec. 900.12.
Finally, FDA is amending Alternative Standard #8, which permitted
interpreting physicians to provide a separate assessment of findings
for each breast in the medical report instead of a single overall
assessment of findings as set forth in Sec. 900.12(c)(1)(iv).
Specifically, the alternative permitted: ``A separate assessment of
findings for each breast, classified in one of the following
categories,'' instead of ``A separate final assessment of findings for
each breast, classified in one of the following categories.'' This
language is being amended to use the term ``final assessment'' to match
the updated language in amended Sec. 900.12(c)(1)(v). As a result of
the amended Sec. 900.12, amending Alternative Standard #8 is justified
by Sec. 900.12.
Dated: August 20, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-19058 Filed 8-23-24; 8:45 am]
BILLING CODE 4164-01-P
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