FDA wants to speed 510(k) approval for medical devices

Part of the latest user-fee agreement was a promise from the Food and Drug Administration that it would speed up the time it takes to rule on new medical devices. Keeping its word, the agency has unveiled a plan to improve response times for 510(k) applications.

The FDA published a guidance saying that by 2017, it plans to reduce the average wait period to 124 days for clearance applications, down from the current 150 days, Mass Device reports. The agency will work its way to that goal gradually, setting benchmarks of 135 days in 2013 and 2014, and 130 in 2014 and 2015. Read the full FierceMedicalDevices article

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