0910-AG48 201610 The Regulatory Plan and the 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 will amend FDA's regulations on acceptance of data for medical devices to require that clinical investigations submitted in support of a research or marketing application submission be conducted in accordance with good clinical practice if conducted outside the United States and in accordance with FDA's regulations if conducted in the United States.

 

]]> 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 12/00/2016 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