4/22/2013

The average time it takes to achieve a pre-market approval decision has dropped about one-third since 2010, while the time to clear medical devices submitted under the 510(k) process has improved about 30%, said Dr. Malvina Eydelman, director of the FDA's Division of Ophthalmic and Ear, Nose and Throat Devices, discussing her area of oversight. The change stems from certain improvements within the FDA, such as a simplified pre-market review process and greater FDA and industry collaboration, she said.

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