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FDA Releases Guidance Documents On PMA, 510(k) Review Times And Goals

The agency outlined how it plans to calculate review times and meet performance goals for PMA and 510(k) submissions in two recent guidance documents.

Two new guidance documents specify the actions FDA can take when reviewing PMAs and 510(k) device submissions, and how these actions affect the overall “FDA review clock” and performance goals established in the latest medical device user fee agreement (MDUFA III) for fiscal years 2013-2017.

The Oct. 16 guidance documents on PMA and 510(k) applications spell out the FDA review times and performance goals agreed upon in the MDUFA III negotiations,...

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