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HHS/FDA

RIN: 0910-AG48

Publication ID: Fall 2017

Title: Human Subject Protection; Acceptance of Data From Clinical Investigations for Medical Devices
Abstract: This rule updates FDA’s requirements for accepting clinical data used to bring new medical devices to market as part of fulfilling FDA’s mission. While helping to ensure the quality and integrity of clinical trial data and the protection of study participants, this rule should generally reduce burden on industry by avoiding the need for on-site inspections. This rule parallels the drug regulation, which should further reduce burden by having a harmonized approach.
Agency: Department of Health and Human Services(HHS)	Priority: Substantive, Nonsignificant
RIN Status: Previously published in the Unified Agenda	Agenda Stage of Rulemaking: Final Rule Stage
Major: No	Unfunded Mandates: No
EO 13771 Designation: Deregulatory
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	03/00/2018

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: Soma Kalb Biomedical Engineer Department of Health and Human Services Food and Drug Administration Center for Devices and Radiological Heath, Building 66, Room 1534, 10903 New Hampshire Avenue, Silver Spring, MD 20993 Phone:301 796-6359 Email: soma.kalb@fda.hhs.gov