About FDA

Third Party Performance Metrics

The Accredited Persons Program was created by the FDA Modernization Act of 1997 (FDAMA) to improve the efficiency and timeliness of FDA's 510(k) process. Under the program, FDA accredits third parties (Accredited Persons) that are authorized to conduct the primary review of 510(k)s for eligible devices. Under MDUFA IV, the FDA committed to publishing the performance of individual accredited Third Parties with at least five completed submissions on the Web (e.g., rate of NSE, average number of holds, average time to SE).

A summary of third party performance metrics will be posted below on a quarterly basis.
 

Performance Report

Date

Performance Report - FY18, 1Q 

1/26/18 

Page Last Updated: 01/26/2018
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