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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: 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