Around 80% of the 510(k) marketing applications for medical devices that the US Food and Drug Administration rejects after reaching a "not substantially equivalent" (NSE) determination are turned down because the sponsor has failed to submit sufficient performance data1.
This was the conclusion of an FDA audit of the agency's 510(k), or pre-market notification, programme for clearing medical devices, which assessed more than 700 NSE decisions made between calendar years 2005 and 2010...
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