FDA proposes more consistent clinical data requirements

By Stewart Eisenhart, Emergo Group

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.

for complete article, http://www.massdevice.com/blogs/massdevice/fda-proposes-more-consistent-clinical-data-requirements