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.
The updated regulations, included in 21 CFR 812.28, do not specify a particular GCP standard for sponsors to follow, but instead include a more flexible definition of principles that it describes as well-recognized and generally accepted. The rule defines GCP as standards for the “design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical investigations” that assure results are accurate and the rights and safety of subjects were protected. This includes initial and continuing ethics committee approval, and obtaining freely given informed consent.
This definition allows sponsors of clinical trials conducted outside the U.S. to determine their own appropriate standard, the FDA said.
As an example of an applicable standard, the agency pointed to the ISO’s GCPs for medical device clinical investigations, ISO 14155:2011, which was recognized by the FDA in 2012 and was developed with the participation of several countries and device companies. The ISO standard is also recognized by most of the members of the International Medical Device Regulators Forum, the agency said.