USFDA Final Guidance and Webinar on “Distinguishing Medical Device Recalls from Medical Device Enhancements”

USFDA had issued a issued a final guidance document titled “Distinguishing Medical Device Recalls from Medical Device Enhancements.” The guidance clarifies for manufacturers how to determine when changes to a device constitute a recall and when they are considered a product enhancement. 

What's inside Guidance?

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.

Webinar on the above Guidance Details:

Date: November 5, 2014

Time: 1:30 PM – 3:00 PM, Eastern Time
To ensure you are connected, log-in by 1:15 PM.

To hear the presentation and ask questions: Dial: 1-888-469-0882; passcode: CDRH

To view the slide presentation during the webinar:
https://www.mymeetings.com/nc/join/
Conference number: PW9036971, Passcode: CDRH
Following the webinar, a transcript, recording and slides will be available at: http://www.fda.gov/Training/CDRHLearn/default.htm