Feb 27, 2013

The US Food and Drug Administration has published a proposed rule that would require medical device clinical studies conducted outside the US in order to support product registrations to be conducted in compliance with Good Clinical Practice (GCP). Part of GCP requires manufacturers using overseas clinical studies in their US registration applications to show proof of review and approval of their studies by Independent Ethics Committees (IEC).

Through the proposed rule, the FDA is seeking to establish consistent clinical data acceptance requirements across all types of medical device applications and submissions, as well as take into account evolving Good Clinical Practice principles.

These new requirements would apply to Investigational Device Exemptions (IDE), 510(k) premarket notification and premarket approval (PMA) submissions, product development protocols and humanitarian device exemptions (HDE). Changes to 510(k) and IDE regulations are also being proposed regarding clinical studies within the US.

Medical device clinical studies done in the US to support 510(k), IDE and HDE applications would have to meet the same requirements currently established for PMA applications—including written statements regarding subject safety and data quality.

The FDA is accepting comments on the proposed rule through May 28, 2013. The rule will go into effect 180 days from the date of its publication in the US Federal Register (February 25, 2013).


  • Stewart Eisenhart