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HHS/FDA RIN: 0910-AH04 Publication ID: Spring 2022 
Title: Mammography Quality Standards Act 

FDA is amending its regulations governing mammography. The amendments will update the regulations issued under the Mammography Quality Standards Act of 1992 (MQSA) and the Federal Food, Drug, and Cosmetic Act (FD&C Act). FDA is taking this action to address changes in mammography technology and mammography processes that have occurred since the regulations were published in 1997 and to address breast density reporting to patient and healthcare providers.

Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Final Rule Stage 
Major: Yes  Unfunded Mandates: No 
CFR Citation: 21 CFR 900   
Legal Authority: 21 U.S.C. 360i    21 U.S.C. 360nn    21 U.S.C. 374(e)    42 U.S.C. 263b   
Legal Deadline:  None
Action Date FR Cite
NPRM  03/28/2019  84 FR 11669   
NPRM Comment Period End  06/26/2019 
Final Rule  09/00/2022 
Regulatory Flexibility Analysis Required: Yes  Government Levels Affected: None 
Small Entities Affected: Businesses  Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: Yes 
Agency Contact:
Laurie Sternberg
Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
Suite 200N (HFM-630), 10903 New Hampshire Avenue, Building 66, Room 5517,
Silver Spring, MD 20993
Phone:240 402-0425