FDA New Draft Guidance: Medical Device Clinical Data from Trials Outside the U.S

Courtney A. Stevens, Esq. | Senior Attorney, Medmarc Loss Control

Last week, the FDA released draft guidance for medical device developers on utilizing clinical data obtained from trials conducted outside the United States. Many view this Guidance as a follow-up on a proposed rule the Agency issued in 2013 (Human Subject Protection; Acceptance of Data from Clinical Studies for Medical Devices), which would require that foreign trials comply with U.S. good clinical practices regulations if in support of a device application. In furthering this effort toward uniformity and consistency among trials internationally, this most recent guidance clarifies the participant protections that need be in place in order for the data to be deemed reliable by the Agency for purposes of application review.

Rather than issuing a blanket requirement that all trials conducted outside the U.S. follow U.S. regulations for the protection of human subjects, the Guidance allows trial sponsors to adhere to local regulations instead, so long as those standards are equal to or greater than the human-subject-protection requirements under the Declaration of Helsinki.