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Device Reporting: More Quantity than Quality

According to Susan Gardner, director of the Office of Surveillance and Biometrics at CDRH, the number of adverse event reports is skyrocketing. Last Friday, Gardner told attendees at MassMEDIC's FDA update on postmarket surveillance in Waltham, Massachusetts that there are some challenges with the medical device reporting system, and FDA needs to make it a "better program". The first problem is that it's a passive surveillance system, meaning it is dependent upon recognition of a problem.

The second flaw is that "people aren't inherently good reporters," thus reports aren't necessarily complete, leading to more quantity than quality. Gardner provided anticipated developments in postmarket surveillance for the next year: 1. CDRH is looking to collaborate with other agencies in developing effective registries for postapproval studies. 2. A pilot program for electronic medical device reporting should be starting in January.  

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