The FDA is putting on a Webinar to go over and answer questions related to the final guidance on Distinguishing Medical Device Recalls from Medical Device Enhancements. http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm419121.htm
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.
Target Audience: Medical Device Industry, Medical Device Industry Associations
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: 888-469-0882; International Callers Dial: 1-517-308-9291; passcode: CDRH
To view the slide presentation during the webinar: https://www.mymeetings.com/nc/join.php?i=PW9036971&p=CDRH&t=c