Medical Device Performance Goals: FDA Offers a Quarterly Update

Posted 09 December 2016 By Zachary Brennan

The US Food and Drug Administration (FDA) on Friday released its latest performance data, revealing that the number of premarket applications (PMAs) for devices with a major deficiency letter on the first FDA review cycle is up to its highest level ever, and up more than 25% since 2015.

PMA

On the approval side, FDA’s Center for Devices and Radiological Health (CDRH) continues to approve PMAs at a high rate and almost as quickly as the agency ever has.

PMA rate

avg

For 510(k)s, more than three-quarters of these applications continue to need to provide additional information to FDA in the first review cycle (though that number falls to only 6% in the second FDA review cycle).

510(k)

And in another positive sign for the device industry: The average time to an FDA decision on 510(k)s has also fallen to historically low levels and the percentage of 510(k)s determined to be substantially equivalent remain at historically high levels.

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Quarterly Update on Medical Device Performance Goals ----MDUFA III CDRH Performance Data ---- Action through 30 September 2016

PMA Monthly approvals from 11/1/2016 to 11/30/2016

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Categories: Medical Devices, Government affairs, Regulatory strategy, Regulatory intelligence, Submission and registration, News, US, CDRH

Tags: 510(k), PMA, FDA approval of medical device, devices substantially equivalent

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