Wednesday, July 20, 2011

The FDA's 510(k) report card

The FDA admits that the average 510(k) review time has increased (to 140 days!) but blames the industry: "FDA data shows that total review time – the time it takes FDA to review an application and for companies to respond to questions that arise during that review – has increased primarily due to companies taking more time to respond to requests for additional information."; see CDRHReports/ucm263385.htm.
From personal experience I know this to be a half-truth. The reason companies need to take more time is that the FDA requires more information than before, and information that was previously not required. So who is the bad guy here?
In my experience, the FDA is making it more and more difficult for the medical device industry to get devices approved, and they're doing this without being upfront, honest and transparent about it.

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