The U.S. Food and Drug Administration (FDA) has released its first report on the performance of accredited third-party reviewers of medical devices.
The FDA’s Accredited Persons Program was developed to improve the efficiency and timeliness of the agency’s premarket notification (510(k)) review process for certain medical devices. Under the program, accredited third-parties are empowered to conduct the primary review of a 510(k) application, helping to speed the review and approval process for eligible devices.
Published in late January, the report presents the findings of the FDA’s initial assessment of seven accredited third parties according to several key performance metrics, including “total third party review time,” “total FDA review time,” and “total time to decision from third party receipt.” For the 18 separate 510(k) submissions evaluated under the assessment, the average “total time to decision from third party receipt was 80 days, with a low of 52 days and a maximum of 172 days.”
The FDA’s third party performance report is the first such report as required under the FDA Reauthorization Act of 2017. While the data reviewed in this report was limited, the FDA says it intends to update third party review performance metrics on a quarterly basis.
Read the complete text of the FDA’s performance report on accredited third-party reviewers.
