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# Third-party 510(k) Review Metrics
- URL: https://www.fdaweb.com/third-party-510-k-review-metrics/
- Published: 2018-01-26T12:00:00.000Z
- Updated: 2026-09-14T23:17:42.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5140607

CDRH has posted [review metrics](https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHTransparency/ucm593823.htm?utm%5Fcampaign=FDA%20Publishes%20Performance%20Metrics%20for%20Accredited%20Third%20Party%20Reviewers%20of%20510%28k%29%20Submissions&utm%5Fmedium=email&utm%5Fsource=Eloqua&elqTrackId=06833E118A7D0091102F3AF4A7B75EFF&elq=7d2bf161b863455ca4f3c7fed2b47ab0&elqaid=2225&elqat=1&elqCampaignId=1559) for its Accredited Persons Program for 510(k)s. The metrics are mandated by the device user fee program. According to the report, 18 third-party 510(k)s have been reviewed. The average total time from receipt of a 510(k) to a final decision was 80 days. This is more than half as fast for CDRH-processed 510(k)s, which averaged 177 days in 2016.