Regulatory Counsel

0910-AH04 201804 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; Amendments to Part 900 Regulations

FDA is proposing to amend its regulations governing mammography. The amendments would update the regulations issued under the Mammography Quality Standards Act of 1992 (MQSA). 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 health care providers.

]]> Economically Significant Previously Published in The Unified Agenda Proposed Rule Stage Yes No Regulatory 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 08/00/2018 Yes Businesses None No No Yes No Erica Payne Regulatory Counsel 0910 Food and Drug Administration FDA 301 796-3999 301 847-8145 erica.payne@fda.hhs.gov Center for Devices and Radiological Health, 10903 New Hampshire Avenue, WO 66, Room 5517, Silver Spring MD 20993