FDA Issues Draft Guidance for Device Industry and Staff for Postmarket Surveillance – Overview and Summary of Recommendations

• By: Staff Editor
• Date: September 23, 2011

On August 16, 2011, the FDA issued draft guidance for the medical device industry and its own staff on how to conduct postmarket surveillance. This new guidance, when it is finalized, is expected to supersede the guidelines issued in 2006.

This article gives an overview of the new guidance and recommendations.