[Federal Register Volume 89, Number 165 (Monday, August 26, 2024)]
[Notices]
[Pages 68446-68447]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-19058]


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

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.

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

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DATES: The relevant Alternative Standards will be withdrawn or amended 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'' (https://www.fda.gov/radiation-emitting-products/regulations-mqsa/mqsa-alternative-standard-11-modifications-assessment-categories-used-medical-reports) and #12 ``Assessment 
category for `Post Procedure Mammograms for Marker Placement' '' 
(https://www.fda.gov/radiation-emitting-products/regulations-mqsa/mqsa-alternative-standard-12-assessment-category-post-procedure-mammograms-marker-placement). FDA is also amending the Alternative Standard #8 
``Separate Assessment for Findings for Each Breast'' (https://www.fda.gov/radiation-emitting-products/regulations-mqsa/mqsa-alternative-standard-8-separate-assessment-findings-each-breast).
    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