FDA proposes more reporting requirements for overseas clinical trials.
The U.S. Food and Drug Administration has proposed more stringent regulations for medical device companies conducting trials overseas, adding more lag time to what many in the industry already see as a frustratingly slow process.
The agency recently released a proposed rule designed to vet data from clinical trials performed outside the United States by requiring, among other things, approval from a foreign independent ethics committee.
The rule would also require documents verifying the committee members' qualifications for the role, their approval process, information about the research facility, and records of informed consent for subjects.
These requirements would apply to trials submitted as support for 510(k) premarket notification submissions, premarket approval applications, product development protocol applications, device exceptions, or a humanitarian device exemption application.
While medical device companies agreed with the general spirit of the rule, they expressed concern in their public comments that the proposed requirements actually made overseas studies much more burdensome to perform than domestic studies.
The companies also expressed concern that the proposal would make companies leery of entering the U.S. market, stifling innovation and slowing down access to new products.
