FDA Is Concluding the Quality in 510(k) Review Program Pilot

April 26, 2021 — After May 30, 2021, the U.S. Food and Drug Administration (FDA) will no longer accept Quality in 510(k) Review Files.  Companies should consider using the electronic Submission Template and Resource (eSTAR).

In September 2018, the FDA launched the Quality in 510(k) Review Program Pilot, to evaluate whether the use of the FDA's free eSubmitter software for creating premarket notifications (510(k)s) for certain moderate risk medical devices will produce well-organized submissions that can be reviewed more efficiently to help promote timely access to safe, effective, and high-quality medical devices.

During the pilot, companies using eSubmitter have produced well-organized submissions. However, with the creation of eSTAR, the FDA identified additional benefits associated with submission preparation using eSTAR rather than eSubmitter. Therefore, the FDA is concluding the Quality in 510(k) Review Program Pilot.

The FDA plans on publishing the results of the Quality in 510(k) Review Pilot.

The FDA will periodically initiate pilot programs to help improve consistency and efficiency in 510(k) review. These pilot programs are intended to aid both industry and FDA staff in using resources effectively. This allows the FDA to direct more effort on the review of higher risk devices, which helps reduce total time to decision, and promotes consistency in 510(k) reviews. The programs do not alter the statutory threshold or data requirements for the determination of substantial equivalence.

For more information: www.fda.gov/medical-devices