On February 21st 2018, the United States (US) Food and Drug Administration (FDA) finalised a rule which requires medical device clinical investigations that are conducted outside the US to flexibly conform to good clinical practice (GCP) standards. Sponsors and applicants are required to provide statements and information regarding how their clinical investigations conform to GCP standards.
The FDA defines GCP as “a standard for the design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical investigations in a way that provides assurance that the data and results are credible and accurate and that the rights, safety, and well-being of subjects are protected.”
FDA requires that data submitted from clinical investigations conducted outside the US intended to support an investigational device exemption (IDE) application, a premarket notification (510(k)) submission, a request for De Novo classification, a premarket approval (PMA) application, a product development protocol (PDP) application, or a humanitarian device exemption (HDE) application be from investigations conducted in accordance with good clinical practice (GCP). This includes obtaining and documenting the review and approval of the clinical investigation by an independent ethics committee (IEC) and obtaining and documenting freely given informed consent of subjects.
To help ensure the quality and integrity of data obtained from these investigations, the final rule updates criteria for FDA acceptance of data from clinical investigations conducted outside the US. The FDA believes that the requirements “provide flexibility for medical device sponsors conducting multinational clinical trials by allowing them to describe the standard for GCP they followed.”
Also amended in the final rule are the IDE, 510(k) and HDE regulations for FDA acceptance of data from clinical investigations conducted within the US to require a statement regarding compliance with FDA regulations for human subject protection, institutional review boards, and IDEs. The change aims to provide consistency across different submission or application types.
The FDA has also published guidance entitled “Acceptance of clinical data to support medical device applications and submissions frequently asked questions.” The guidance provides clarification and recommendations to help ensure studies conducted in the US or foreign countries comply with the new rule and revised regulations.
To view the Final Rule: Human Subject Protection; Acceptance of Data from Clinical Investigations for Medical Devices, please click here.