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Mammography Quality Standards Act and Regulation Amendments: Small Entity Compliance Guide; Guidance for Industry and Food and Drug Administration Staff; Availability

The Food and Drug Administration published this final rule in the Federal Register on August 26, 2024.

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What the agency says

The Food and Drug Administration (FDA or the Agency) is announcing the availability of a guidance for industry entitled "Mammography Quality Standards Act and Regulation Amendments: Small Entity Compliance Guide." The Mammography Quality Standards Act of 1992 (MQSA) final rule amended FDA's regulations to address, among other things, standards for accreditation bodies, certifying agencies, mammography equipment, quality assurance testing, and clinical image quality, as well as to require certain breast density information be provided by mammography facilities to patients and their healthcare providers. The small entity compliance guide (SECG) is intended to help small entities comply with the MQSA final rule.

Key facts

Document number
2024-19059
Type
Final rule
Action
Notification of availability
Agency
Health and Human Services Department; Food and Drug Administration
Published
August 26, 2024
Dates
August 26, 2024.
Docket
Docket No. FDA-2013-N-0134
Code of Federal Regulations
21 CFR 900
Pages
2

The document on federalregister.gov PDF

Other documents from the Food and Drug Administration

Everything from the Food and Drug Administration · Published in August 2024

Read from the Federal Register API, last updated 2026-10-23. The document on federalregister.gov is the official record; dates and dockets can change through later corrections. Free to reuse with credit to SpecStream under CC BY 4.0.