viernes, 26 de enero de 2018

FDA Publishes Performance Metrics for Accredited Third Party Reviewers of 510(k) Submissions

Today, the FDA published performance metrics for accredited third party reviewers. The Accredited Persons Program was created by the FDA Modernization Act of 1997 (FDAMA) to improve the efficiency and timeliness of the FDA's premarket notification [510(k)] process. Under the program, the FDA accredits third party reviewers (accredited persons) to conduct the primary review of 510(k)s for eligible devices. Under the FDA Reauthorization Act of 2017 and the associated reauthorization of theMedical Device User Fee Amendments, the FDA committed to publishing the performance of individual accredited third party reviewers with at least five completed submissions on the web.  Today the FDA initiated such reporting and intends to update third party reviewer performance metrics on a quarterly basis.

Food and Drug Administration
Center for Devices and Radiological Health

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