The FDA has issued a draft guidance updating the standards the agency uses in accepting data from clinical studies on medical devices conducted outside the U.S.
These guidelines are used to ensure “the protection of human subjects and the quality and integrity of data obtained from these studies,” according to the FDA.
The focus of the draft guidance is on the acceptance of scientifically valid clinical data from foreign studies supporting premarket submissions for devices. It includes special considerations, such as applicability of data to intended patient populations within the U.S. It also highlights potential study design issues and provides recommendations for the development of adequate data.
A 2013 proposed rule from the FDA addressed ethical considerations related to clinical trials, requiring that clinical studies conducted outside the U.S. supporting premarket submissions be conducted in accordance with good clinical practice by seeking approval from an independent ethics committee and documenting informed consent from study subjects.
The newly released draft guidance “is not intended to announce new policy, but to describe FDA’s existing approach to this topic,” according to the agency.
A comment period on the guidance will be open July 20.