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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:
Aaliyah K. Eaves
Policy Advisor, Office of the Director
Department of Health and Human Services
Food and Drug Administration
Center for Devices and Radiological Health, WO 66, Room 5422, 10903 New Hampshire Avenue,
Silver Spring, MD 20993
Phone:301 796-2948
Fax:301 847-8120
Email: aaliyah.eaves-leanos@fda.hhs.gov

 
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