martes, 14 de octubre de 2014

CDRH Industry: ANNOUNCING Final Guidance and FDA Webinar on “Distinguishing Medical Device Recalls from Medical Device Enhancements”

Today the Food and Drug Administration (FDA) issued a final guidance document, “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.

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.

On November 5, 2014, the FDA will hold a webinar to explain the guidance and to provide a forum for asking questions.   Registration is not necessary.
Webinar 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:

Conference number: 
PW9036971Passcode: CDRH
Following the webinara transcript, recording and slides will be available at:

If you have any questions regarding this guidance, please contact the Division of Industry and Consumer Education (DICE) in the Center for Devices and Radiological Health (CDRH) at 1-800-638-2041, 301-796-7100 or
Food and Drug Administration
Center for Devices and Radiological Health

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