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HHS/FDA RIN: 0910-AG48 Publication ID: Spring 2010 
Title: ●Human Subject Protection; Acceptance of Clinical Studies Conducted Outside the United States 
Abstract: The Food and Drug Administration (FDA) is proposing to amend its regulations on acceptance of data from clinical studies conducted outside the United States in support of a premarket approval application or a humanitarian device exemption application for a medical device. FDA is proposing to require that these studies be conducted in accordance with good clinical practice (GCP). FDA proposes to define GCP as a standard for the design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical trials in a way that provides assurance that the data and reported results are credible and accurate, and that the rights, safety, and well-being of trial subjects are protected. GCP also would include review and approval by an independent ethics committee (IEC) before initiating a study, continuing IEC review of ongoing studies, and obtaining and documenting freely given informed consent of study subjects. FDA is also proposing to include requirements for the submission of clinical data in support of an investigational device exemptions application and a premarket notification submission. The proposed changes will require a statement regarding compliance with FDA regulations for studies conducted in the United States and compliance with GCP for studies conducted outside the United States. With the above described changes, the proposed rule is intended to update the standards for the acceptance of clinical studies and to help to continue to ensure the protection of human subjects and the quality and integrity of data obtained from these studies. 
Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: First time published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: No  Unfunded Mandates: No 
CFR Citation: 21 CFR 812.2(e); 21 CFR 812.3(t); 21 CFR 812.27(b)(4); 21 CFR 812.28; 21 CFR 814.15; 21 CFR 814.20(b)(6)(ii)(C); 21 CFR 814.45(a)(5); 21 CFR 814.46(a)(4); 21 CFR 807.87(j); ... (To search for a specific CFR, visit the Code of Federal Regulations.
Legal Authority: 21 USC 331; 21 USC 351 to 352; 21 USC 360; 21 USC 360c; 21 USC 360e to 360h; 21 USC 360j 
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM   12/00/2010   
NPRM Comment Period End  03/00/2011   
Regulatory Flexibility Analysis Required: No  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: No 
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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