Final FDA Rule to Require Foreign Device GCPCompliance Comes into Effect

Posted21 February 2019 | By AnaMulero 

The US Food and Drug Administration (FDA) final rule that requires foreign clinicalinvestigations 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’srequirements for the acceptance of data derived from medical device clinicalinvestigations, regardless of the type of marketing submission or applicationand whether the investigation was conducted in or outside of the US.

Exactly one year ago, the final rule set a requirement for sponsors and applicantsconducting medical device investigations overseas to provide a statement of GCPcompliance. It also amended regulations on certain submissions and applicationsfor US investigations to require a statement of compliance with set regulationsin the areas of human subject protection, institutional review boards andinvestigational device exemption (IDE) applications. These include IDEs, 510(k)submissions and humanitarian device exemption (HDE) applications. Therequirement on foreign investigations also applies to premarket approvalapplications (PMAs), de novo classification requests and product developmentprotocols.

To help sponsors and applicants comply with the new and updated requirements,FDA’s Center for Devices and Radiological Health (CDRH) issued guidance on theacceptance of clinical data to support applications and submissions. Thiswas issued along with the release of the final rulelast February.

In a notice sent on Thursday to remind industry of the effective date, CDRHnoted that the final rule applies to all clinical investigations that enrollthe 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 therequirements of the final rule and final guidances on refuse-to-accept (RTA)policies that received minor updates to reflect these requirements. Theguidances on RTA policies for 510(k) submissions and PMA applicationswere updated last January.