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FDA to End Successful Quality in 510(k) Review Program Pilot

May 3, 2021

The FDA has announced that it will conclude its Quality in 510(k) Review Program pilot by May 30 and will no longer accept submissions after that date, directing companies to consider using its electronic Submission Template And Resource (eSTAR) pilot program instead.

The concluding pilot was successful in generating well-organized 510(k) submissions, the agency said, but it found that the eSTAR pilot program, which uses a PDF submission template, improved the preparation of submissions.  

The agency kicked off the Quality in 510(k) Review pilot in September 2018 with the goal of simplifying how devicemakers submit certain 510(k) notifications using the online eSubmitter system. The aim of the pilot program was to assess if use of the software would lead to well-organized submissions that allowed for more efficient device reviews.

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