Next year, the FDA will begin to require that data from medical device studies conducted outside the U.S. be gathered in accordance with good clinical practices, including review and approval from an independent ethics committee and well-documented informed consent.
The agency’s final rule applies to data intended to support IDE applications, 510(k) submissions, and de novo classification requests, as well as applications for premarket approval, product development protocols and humanitarian device exemptions. It also applies to bench and in vitro diagnostic studies of de-identified specimens.
The FDA is also amending its regulations for IDE, 510(k) and HDE submissions based on domestic U.S. studies — to provide consistency in the agency’s requirements for clinical data regardless of the type of application — adding requirements for statements of compliance with FDA regulations covering human subject protection and institutional review boards.
As the globalization of clinical trials continues, the agency is working to ensure that GCPs are followed in overseas studies by employing a more modernized approach, said FDA Commissioner Scott Gottlieb.
