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HHS/FDA RIN: 0910-AG48 Publication ID: Fall 2016 
Title: Human Subject Protection; Acceptance of Data From Clinical Investigations for Medical Devices 
Abstract:

This rule will amend FDA's regulations on acceptance of data for medical devices to require that clinical investigations submitted in support of a research or marketing application submission be conducted in accordance with good clinical practice if conducted outside the United States and in accordance with FDA's regulations if conducted in the United States.

 

 
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: No  Unfunded Mandates: No 
CFR Citation: 21 CFR 807    21 CFR 812    21 CFR 814   
Legal Authority: 21 U.S.C. 321    21 U.S.C. 331    21 U.S.C. 351    21 U.S.C. 352    21 U.S.C. 360    21 U.S.C. 360c    21 U.S.C. 360e    21 U.S.C. 360i    21 U.S.C. 360j    21 U.S.C. 371    21 U.S.C. 374    21 U.S.C. 381    21 U.S.C. 393    42 U.S.C. 264    42 U.S.C. 271    ...   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  02/25/2013  78 FR 12664   
NPRM Comment Period End  05/28/2013 
Final Action  12/00/2016 
Regulatory Flexibility Analysis Required: Yes  Government Levels Affected: None 
Small Entities Affected: Businesses  Federalism: No 
Included in the Regulatory Plan: No 
International Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be of international interest.
RIN Data Printed in the FR: Yes 
Agency Contact:
Soma Kalb
Biomedical Engineer
Department of Health and Human Services
Food and Drug Administration
Center for Devices and Radiological Heath, Building 66, Room 1534, 10903 New Hampshire Avenue,
Silver Spring, MD 20993
Phone:301 796-6359
Email: soma.kalb@fda.hhs.gov