Regulatory Counsel

0910-AH04 202104 Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS 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.

]]> Other Significant Previously Published in The Unified Agenda Final Rule Stage Yes No 21 CFR 900 21 U.S.C. 360i 21 U.S.C. 360nn 21 U.S.C. 374(e) 42 U.S.C. 263b Yes NPRM 03/28/2019 84 FR 11669 NPRM Comment Period End 06/26/2019 Final Rule 09/00/2021 Yes Businesses None No No Yes No Laurie Sternberg Regulatory Counsel 0910 Food and Drug Administration FDA 240 402-0425 laurie.sternberg@fda.hhs.gov Suite 200N (HFM-630), 10903 New Hampshire Avenue, Building 66, Room 5517, Silver Spring MD 20993