FDA Device Recall Summary Page

The FDA webpage with a summary of how medical device recalls are handled and how FDA may notify the public is at the link provided. This includes examples of types of recall actions. We post software-related recalls on this website and SoftwareCPR can provide expert assistance in compliance with 21 CFR Part 806 Corrections and Removals as well as corresondence or negotiations with FDA in handling all types of recalls and to help ensure public notifications are fairly stated.

FDA Device Recall Summary Page

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