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HHS/FDA RIN: 0910-AG48 Publication ID: Spring 2018 
Title: Human Subject Protection; Acceptance of Data From Clinical Investigations for Medical Devices 

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 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. Under this new rule, a device applicant would provide FDA with information about the conduct of their study such as, the research sites where the study was conducted, the investigators who conducted the study, a summary of the protocol, information about how informed consent from the study participants was obtained, and information about the ethics committee that reviewed the study. (If such information is not available, the sponsor may explain why and request a waiver.)

Agency: Department of Health and Human Services(HHS)  Priority: Substantive, Nonsignificant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Completed Actions 
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
Action Date FR Cite
NPRM  02/25/2013  78 FR 12664   
NPRM Comment Period End  05/28/2013 
Final Action  02/21/2018  83 FR 7366   
Final Action Effective  02/21/2019 
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