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HHS/FDA RIN: 0910-AH04 Publication ID: Fall 2019 
Title: Mammography Quality Standards Act; Amendments to Part 900 Regulations 
Abstract:

FDA is amending its regulations governing mammography. The amendments would 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: Economically Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Final Rule Stage 
Major: Yes  Unfunded Mandates: No 
EO 13771 Designation: Regulatory 
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
Timetable:
Action Date FR Cite
NPRM  03/28/2019  84 FR 11669   
NPRM Comment Period End  06/26/2019 
Final Rule  09/00/2020 
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:
Erica Payne
Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
Center for Devices and Radiological Health, 10903 New Hampshire Avenue, WO 66, Room 5517,
Silver Spring, MD 20993
Phone:301 796-3999
Fax:301 847-8145
Email: erica.payne@fda.hhs.gov