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GUIDANCE DOCUMENT

Mammography Quality Standards Act and Regulation Amendments: Small Entity Compliance Guide Guidance for Industry and Food and Drug Administration Staff August 2024

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2013-N-0134
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

FDA has developed this Small Entity Compliance Guide (SECG) to explain the actions a small entity is required to take to comply with the MQSA rule and its implementing regulations. The March 2023 MQSA rule modernized mammography regulations and specifies that the mammography report given to patients specifies if the patient has dense or non dense breast tissue and includes a prescribed paragraph on the significance of breast density. The SECG also includes policy and recommendations previously found in the Policy Guidance Help System. 

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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

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5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2013-N-0134.

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