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HHS/FDA RIN: 0910-AI20 Publication ID: Spring 2020 
Title: Clinical Holds in Medical Device Investigations 

The proposed rule would create a regulatory framework and procedures for suspending, i.e., imposing a hold (a "clinical hold") on, a clinical investigation of a medical device. The proposed rule would implement section 520(g)(8) of the Federal Food, Drug, and Cosmetic Act authorizing clinical holds for device investigations.

Agency: Department of Health and Human Services(HHS)  Priority: Substantive, Nonsignificant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: No  Unfunded Mandates: No 
EO 13771 Designation: Regulatory 
CFR Citation: 21 CFR 812   
Legal Authority: 21 U.S.C. 360j(g)(8)    21 U.S.C. 371(a)   
Legal Deadline:  None
Action Date FR Cite
NPRM  09/00/2020 
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Small Entities Affected: No  Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Agency Contact:
John Maiers
Regulatory Policy Analyst
Department of Health and Human Services
Food and Drug Administration
10903 New Hampshire Avenue, Building 66, Room 5500, Center for Devices and Radiological Health,
Silver Spring, MD 20993
Phone:301 796-0343