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 §§ 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 § 900.12 (as amended in that final rule), in accordance with § 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 § 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 § 900.18. Under § 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 § 900.12. For the reasons discussed below, FDA has determined that withdrawing and/or amending the Alternative Standards is justified by § 900.12.

FDA has determined that withdrawing Alternative Standard #11 is justified by § 900.12. Alternative Standard #11 provided an alternative standard to § 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 § 900.12(c)(1)(iv) includes the additional assessment category “Known Biopsy-Proven Malignancy” and amended § 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 § 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 ( printed 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 § 900.12.

FDA also has determined that withdrawal of Alternative Standard #12 is justified by § 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 § 900.12(c)(1)(iv)(G). Because amended § 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 § 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 § 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 § 900.12(c)(1)(v). As a result of the amended § 900.12, amending Alternative Standard #8 is justified by § 900.12.