Companies should consider using the electronic Submission Template and Resource (eSTAR).

If your email program has trouble displaying this email, view as a webpage. Update: FDA Is Concluding the Quality in 510(k) Review Program Pilot After May 30, 2021, the 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 U.S. Food and Drug Administration (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. Learn More Questions? If you have questions about the Quality in 510(k) Review Program Pilot, contact the Division of Industry and Consumer Education.

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