0910-AG48 201704 Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS 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.)  

]]> Other Significant Previously Published in The Unified Agenda Final Rule Stage No No 21 CFR 807 21 CFR 812 21 CFR 814 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 ... No NPRM 02/25/2013 78 FR 12664 NPRM Comment Period End 05/28/2013 Final Action 12/00/2017 Yes Businesses None No Yes Yes Soma Kalb Biomedical Engineer 0910 Food and Drug Administration FDA 301 796-6359 soma.kalb@fda.hhs.gov Center for Devices and Radiological Heath, Building 66, Room 1534, 10903 New Hampshire Avenue, Silver Spring MD 20993