USFDA CDRH Webinar on Distinguishing Medical Device Recalls from Medical Device Enhancements conducted on 5th Nov 2014..

Webinar: Distinguishing Medical Device Recalls from Medical Device Enhancements – Final Guidance

Summary: The guidance clarifies for manufacturers how to determine when changes to a device constitute a recall and when they are considered a product enhancement.

The guidance contains clear definitions and practical examples to help manufacturers distinguish a recall from an enhancement. Correctly identifying a change to a device as a recall reduces the time between identification of a device defect/failure and public notification.

Clarifying when a change to a device represents a recall or an enhancement will help manufacturers better understand when reporting device changes to the FDA is required.

View/Download Printable Slides of the Webinar CLICK HERE