Mammography Quality Standards Act — 2024 Final Rule
88 FR 15126 · Docket No. FDA-2013-N-0134 · Effective September 10, 2024
- 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) represents the FDA's comprehensive modernization of mammography regulations under the Mammography Quality Standards Act of 1992. Developed over a decade of rulemaking (proposed rule published March 28, 2019), the final rule addresses current science, advances in mammography technology, and gaps identified during MQSA program administration. It applies to all mammography facilities except those operated by the Department of Veterans Affairs. The rule took effect September 10, 2024 — the compliance date all MQSA-certified facilities must meet.
Key Contents
-Mandatory breast density notification: standardized lay-language statements for both dense and non-dense tissue required in every patient lay summary
-Four standardized BI-RADS density categories (A–D) required in the written mammography report provided to the healthcare provider
-Mammography report content requirements: facility name, city, State, ZIP, phone, interpreting physician name, and overall assessment in quotation-mark words or phrases
-Seven final assessment categories defined in regulation: Negative, Benign, Probably Benign, Suspicious, Highly Suggestive of Malignancy, Known Biopsy-Proven Malignancy, and Post-Procedure Mammogram for Marker Placement
-Report delivery timeframes: lay summary within 30 calendar days; written report to provider for Suspicious or Highly Suggestive of Malignancy within 7 calendar days
-Patient and referring provider notification (PPN) system: facilities must maintain a system to refer self-referred patients to a healthcare provider when clinically indicated
-Medical outcomes audit requirements: facilities must track and report PPV, cancer detection rate (CDR), and recall rate; analysis must be individual and collective for all interpreting physicians
-Personnel qualification records: facilities must retain records of former employees for at least 24 months from departure date and provide copies to current IPs, technologists, and physicists on request
-Accreditation body restrictions: no AB may accept an application from a facility that failed three consecutive accreditation attempts until 1 year after the most recent failure
-Equipment standards: mammograms must be interpreted in the original mammographic modality; hardcopy-to-digital conversion prohibited; DBT and digital modality requirements updated
-Facility closure/cessation: facilities ceasing mammography must arrange ongoing access to records for patients and providers for the retention period; MQSA records may be permanently transferred to patients
-Certificate suspension/revocation grounds expanded: includes failure to comply with records requests, aiding/abetting violations, failure to comply with prior sanctions, and failure to provide current/former employee qualification records
-Additional mammography review (AMR): State certification agency added as an entity that may initiate an AMR; patient and public notification provisions strengthened
How This Applies to Your Practice
This final rule is the regulatory foundation for MammoComply. Every compliance category in MammoComply — breast density notification language, assessment category documentation, lay summary delivery, medical outcomes audit tracking, and personnel records retention — traces directly to a section of this rule. Facilities should read this document alongside the MQSA Inspection Manual to understand not just what to do, but the regulatory authority behind each requirement.
Practitioner Implications
Every MQSA-certified facility must have been in full compliance with this rule since September 10, 2024. The two most operationally impactful changes are: (1) mandatory breast density notification in lay summaries using the specific regulatory language in § 900.12(c)(2)(iii) and (iv), and (2) medical outcomes audit tracking of PPV, CDR, and recall rate at both the facility and individual interpreting physician level. Facilities that have not updated their lay summary templates, report workflows, or audit systems since before September 2024 are likely out of compliance.