FDA Proposal Would Require all Device Trials, Regardless of Location, to Adhere to FDA Regulations
Published March 18, 2013 by OSP
The FDA proposed a regulation that would require that all clinical studies on investigational and already-approved medical devices conducted outside the US adhere to good clinical practice guidelines. The change would notably require sponsors to obtain approval from an IRB and obtain and document informed consent of study participants. Regulators noted that the proposed rule would also affect requirements for studies conducted inside the US as well, which they said would make requirements for clinical data acceptance more consistent.