FDA Issues Proposed Rule Affecting Acceptance of Data from Medical Device Clinical Studies

By Jennifer D. Newberger –

FDA issued a proposed rule to amend its regulations on acceptance of data from medical device clinical studies.  The primary proposed changes include:

• Requiring that clinical studies conducted outside the United States to support any submission to FDA, including a 510(k) or IDE, be conducted in accordance with good clinical practices ("GCPs");
• Adopting a definition of GCPs;
• Amending the IDE and 510(k) regulations to address requirements for FDA acceptance of data from clinical studies conducted within the United States;
• For PMAs, updating standards for accepting data from outside the United States by replacing the requirement to be in compliance with the Declaration of Helsinki with compliance with GCPs;
• Amending Parts 807 and 812 to incorporate GCPs into the requirements for FDA acceptance of data from studies outside the United States to support a 510(k) or IDE; and
• Amending Part 812 to impose different requirements for nonsignificant risk versus significant risk studies conducted outside the United States, mirroring the current IDE regulations.

FDA believes that taking these steps will “help provide greater assurance of the quality and integrity of the data obtained from clinical studies conducted outside the United States and submitted in support of an application or submission to FDA.”  By eliminating the requirement to comply with the Declaration of Helsinki and replacing it with the GCP standard “provides a unifying approach, which may simply [trials outside the United States] and decrease the regulatory burden on sponsors.”  The GCP requirements also will make acceptance of foreign data for device studies more consistent with those for drugs and biologics.