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HHS/FDA | RIN: 0910-AH04 | Publication ID: Spring 2021 |
Title: Mammography Quality Standards Act | |
Abstract:
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. |
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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 |
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Timetable:
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Regulatory Flexibility Analysis Required: Yes | Government Levels Affected: None |
Small Entities Affected: Businesses | Federalism: No |
Included in the Regulatory Plan: Yes | |
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 Email: laurie.sternberg@fda.hhs.gov |