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# FDA Shows Improving Device Reviews
- URL: https://www.fdaweb.com/fda-shows-improving-device-reviews/
- Published: 2016-06-02T12:00:00.000Z
- Updated: 2026-09-14T21:06:49.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5135826

The average time for FDA to review and make a decision on 510(k)s dropped to 122 days in FY 2015, which is five days faster than 2014, and 23 days (16%) faster than in 2012 when it took 145 days, according to just-released medical device user fee [statistics](http://www.fda.gov/downloads/ForIndustry/UserFees/MedicalDeviceUserFee/UCM504583.pdf?ref=fdaweb.com). For PMA decisions, the average time is running at 243 days, which is 67 days (22%) faster than in 2012 when it took 310 days.FDA is currently approving 86% of the PMAs submitted, according to the report. Back in 2012, only 70% of the PMAs submitted were being approved. For 510(k)s, 83% are receiving substantially equivalent decisions, which is 14% better than 2011 when 73% were cleared.