MQSA 2024: Small Entity Compliance Guide — Notice of Availability
89 FR 68364 · FDA Guidance for Industry · August 26, 2024
- Publisher
- U.S. Food and Drug Administration / Federal Register
- Author
- FDA Division of Mammography Quality Standards (DMQS); signed Lauren K. Roth, Associate Commissioner for Policy
- Edition
- 89 FR 68364, 2024
- Pages
- 2 pages
- Added to library
- Added August 20, 2026
Overview
This two-page Federal Register notice (Vol. 89, No. 165) formally announces FDA's publication of the Small Entity Compliance Guide for the Mammography Quality Standards Act and Regulation Amendments. The SECG was developed in response to the March 10, 2023 Final Rule (88 FR 15126), which made the most significant changes to MQSA regulations in over 20 years. The notice identifies key regulatory areas addressed — accreditation body standards, certifying agency requirements, mammography equipment standards, quality assurance testing, clinical image quality, and breast density notification requirements. It also confirms the SECG is classified as Level 2 FDA guidance, meaning it does not establish legally enforceable rights for any person but represents FDA's current thinking on how to achieve compliance. The underlying rule became effective September 10, 2024.
Key Contents
-Official FDA announcement of the SECG's availability (Level 2 guidance, non-binding)
-Confirms the MQSA Final Rule (21 CFR Part 900) effective date: September 10, 2024
-SECG covers: accreditation body standards, certifying agency requirements, mammography equipment, quality assurance testing, clinical image quality, and breast density notification
-Docket: FDA-2013-N-0134; associated with the March 10, 2023 Final Rule (88 FR 15126)
-SECG available via FDA CDRH guidance documents portal and regulations.gov
-Contact for hard copy requests: Office of Policy, Guidance and Policy Development, CDRH, FDA — 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993
-FDA contact: Preetham Sudhaker, Division of Mammography Quality Standards (DMQS), CDRH
-Document number for requesting SECG: GUI00007024
-Note: guidance does not establish rights for any person and is not binding on FDA or the public
How This Applies to Your Practice
The SECG is the FDA's official 'plain English' translation of the 2024 MQSA Final Rule. Where the Final Rule (88 FR 15126) is dense regulatory text, the SECG walks through each requirement in accessible language designed for small mammography facilities that may not have legal or compliance staff. MammoComply users should read the SECG alongside the Final Rule to understand the intent behind each regulatory change — particularly around breast density notification language, assessment categories, and the medical outcomes audit — before mapping those requirements to their facility's compliance documentation.
Practitioner Implications
Any facility that received the Final Rule (88 FR 15126) and found it difficult to parse should obtain and read the SECG. The SECG carries no independent legal force — it does not add requirements beyond the Final Rule — but it is the clearest statement of what FDA expects facilities to do. Because it is a Level 2 guidance, inspectors may reference it when evaluating facility compliance, making it functionally important even if technically non-binding. Download the full SECG from the FDA CDRH guidance documents page using document number GUI00007024.