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HHS/FDA

RIN: 0910-AG48

Publication ID: Spring 2015

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 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 if conducted outside 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	12/00/2015

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