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Document of the Week...

Devices & Third Party Review

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 This FDA report, which summarizes Third Party Performance Metrics, covers FY2018 through the 3rd quarter of FY2021 and looks at review time, hold time and total decision time by individual accredited parties.

Featured until September 21, 2021. Click here to download.