Regulatory Policy Analyst

0910-AI20 201910 The Regulatory Plan and the Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS 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, any investigation involving human subjects (a "clinical investigation"), whenever the test article is a medical device. The proposed rule would implement section 606 of the Food and Drug Administration Safety and Innovation Act authorizing clinical holds for device investigations subject to the Federal Food, Drug, and Cosmetic Act.

]]> Substantive, Nonsignificant Previously Published in The Unified Agenda Proposed Rule Stage No No Regulatory 21 CFR 812 21 U.S.C. 360j(g)(8) 21 U.S.C. 371 No NPRM 02/00/2020 No No None No No No John Maiers Regulatory Policy Analyst 0910 Food and Drug Administration FDA 301 796-0343 john.maiers@fda.hhs.gov 10903 New Hampshire Avenue, Building 66, Room 5500, Center for Devices and Radiological Health, Silver Spring MD 20993