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View EO 12866 Meetings Printer-Friendly Version     Download RIN Data in XML

HHS/FDA RIN: 0910-AG48 Publication ID: Spring 2014 
Title: Human Subject Protection; Acceptance of Data From Clinical Studies for Medical Devices 
Abstract: This rule will amend FDA's regulations on acceptance of data from clinical studies for medical devices to require that clinical studies conducted outside the United States in support of a premarket approval application, humanitarian device exemption application, an investigational device exemption application, or a premarket notification submission be conducted in accordance with good clinical practice. 
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 USC 321; 21 USC 331; 21 USC 351; 21 USC 352; 21 USC 360; 21 USC 360c; 21 USC 360e; 21 USC 360i; 21 USC 360j; 21 USC 371; 21 USC 374; 21 USC 381; 21 USC 393; 42 USC 264; 42 USC 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  12/00/2014   
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:
Sheila Anne Brown
Policy Analyst, Investigational Device Exemptions Staff
Department of Health and Human Services
Food and Drug Administration
WO 66, Room 1651, 10903 New Hampshire Avenue,
Silver Spring, MD 20993
Phone:301 796-6563
Fax:301 847-8120
Email: sheila.brown@fda.hhs.gov

 
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