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HHS/FDA RIN: 0910-AI20 Publication ID: Fall 2023 
Title: Clinical Holds in Medical Device Investigations 

The proposed rule would create 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: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: No  Unfunded Mandates: No 
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  06/00/2024 
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Small Entities Affected: Businesses  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