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

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