Final FDA Rule to Require Foreign Device GCP Compliance Comes into Effect
The US Food and Drug Administration (FDA) final rule that requires foreign clinical investigations for medical devices to comply with good clinical practice (GCP) requirements came into effect on Thursday.The 2018 final rule is intended to provide consistency in the agency’s requirements for the acceptance of data derived from medical device clinical investigations, regardless of the type of marketing submission or application and whether the investigation was conducted in or outside of the US.
Exactly one year ago, the final rule set a requirement for sponsors and applicants conducting medical device investigations overseas to provide a statement of GCP compliance. It also amended regulations on certain submissions and applications for US investigations to require a statement of compliance with set regulations in the areas of human subject protection, institutional review boards and investigational device exemption (IDE) applications. These include IDEs, 510(k) submissions and humanitarian device exemption (HDE) applications. The requirement on foreign investigations also applies to premarket approval applications (PMAs), de novo classification requests and product development protocols.
To help sponsors and applicants comply with the new and updated requirements, FDA’s Center for Devices and Radiological Health (CDRH) issued guidance on the acceptance of clinical data to support applications and submissions. This was issued along with the release of the final rule last February.
In a notice sent on Thursday to remind industry of the effective date, CDRH noted that the final rule applies to all clinical investigations that enroll the first subject on or after 21 February 2019 and that support IDEs, 510(k)s, de novos, PMAs, HDEs or product development protocols.
CDRH also pointed to a new webpage aimed at aiding in compliance with the requirements of the final rule and final guidances on refuse-to-accept (RTA) policies that received minor updates to reflect these requirements. The guidances on RTA policies for 510(k) submissions and PMA applications were updated last January.