Mammography Quality Standards Act | 2024 Final Rule
88 FR 15126 · Docket No. FDA-2013-N-0134 · Effective September 10, 2024
Last Reviewed: August 20, 2026
- Publisher
- U.S. Food and Drug Administration / Federal Register
- Author
- FDA Division of Mammography Quality Standards (DMQS)
- Edition
- Final Rule — 88 FR 15126, 2023
- Pages
- 46 pages
- Added to library
- Added August 20, 2026
Overview
This 46-page Federal Register final rule (21 CFR Part 900) is the most comprehensive revision to MQSA regulations since the original quality standards were published October 28, 1997 (62 FR 55852). Published March 10, 2023, and effective September 10, 2024, the rule amends §§ 900.1, 900.2, 900.3, 900.4, 900.11, and 900.12 of 21 CFR Part 900. The rulemaking originated with a proposed rule published March 28, 2019 (84 FR 11879, Docket No. FDA-2019-N-0188), received more than 800 public comments, and was finalized after four years of agency review. The rule applies to all mammography facilities in the United States except those operated by the Department of Veterans Affairs. Primary regulatory changes: (1) mandatory breast density notification in both the provider's written mammography report and the patient lay summary, using one of four standardized density categories corresponding to the ACR BI-RADS® A-D classification; (2) strengthened medical outcomes audit requirements adding mandatory tracking of PPV, cancer detection rate (CDR), and recall rate at both facility and individual interpreting physician levels; (3) enhanced report content requirements including seven defined final assessment categories and complete facility contact information; (4) updated equipment standards addressing digital and DBT modalities and prohibiting hardcopy-to-digital image conversion; (5) expanded certificate suspension and revocation grounds; (6) facility cessation obligations ensuring continued patient access to mammographic records; and (7) a patient and provider notification (PPN) system requirement for self-referred patients.
How This Applies to Your Practice
The 2024 Final Rule is the single most important regulatory document in the MammoComply platform. Every compliance category in MammoComply traces directly to a specific provision of this rule. MammoComply's density notification module implements §§ 900.12(c)(2)(iii)-(iv), which mandate the exact standardized language that must appear in lay summaries for both dense and non-dense tissue findings. The MOA tracking module implements § 900.12(f)(1)(i), which requires facilities to calculate PPV, CDR, and recall rate at least quarterly at both the facility level and for each individual interpreting physician. The personnel file and credential management module implements the records retention requirements at §§ 900.12(a)(1)(vi) and 900.12(g)(2)(ii)(B), including the requirement to retain records of former employees for at least 24 months from their departure date. The lay summary delivery tracking implements the two delivery windows at § 900.12(c)(2): 30 calendar days for all patients, and 7 calendar days for assessments of Suspicious or Highly Suggestive of Malignancy. Facilities should read this rule alongside the MQSA Inspection Manual to understand not just what each MammoComply module tracks, but the precise regulatory authority and penalty exposure behind each requirement.
Practitioner Implications
All MQSA-certified facilities must have been in full compliance since September 10, 2024. Critical compliance items: (1) Density notification language: lay summaries must use one of the four standardized statements prescribed in § 900.12(c)(2)(iii)-(iv), verbatim or substantially equivalent language. Facilities that retained pre-2024 density language or adopted non-conforming vendor-supplied templates are out of compliance. (2) Medical outcomes audit: PPV (biopsy-recommended cases confirmed as cancer), CDR, and recall rate must be compiled and reviewed at least quarterly for each interpreting physician individually and for the facility collectively (§ 900.12(f)(1)(i)(B)). Aggregate-only tracking is no longer sufficient. (3) Mammography report content: report must include the facility's name, city, state, ZIP, and telephone, plus the interpreting physician's full name, and must state the final assessment using one of the seven defined category phrases in quotation marks. (4) PPN system: every facility must document a formal policy for referring self-referred patients to a healthcare provider when clinically indicated. (5) Accreditation: facilities that have failed three consecutive accreditation cycles must wait one full year from the most recent failure date before reapplying (§ 900.3(d)(3)).
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