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This announcement addresses one of the commitments in FDA's Medical Device Safety Action Plan: Protecting Patients, Promoting Public Health.

Progress of Pre-Submissions for Medical Devices Now Trackable Through CDRH Portal - Medical device manufacturers must submit applications for certain classes of medical...

The U.S. Food and Drug Administration (FDA) has finalized its guidance “Electronic Submission Template for Medical Device 510(k) Submissions,” which will require medical device 510(k)...

The committee was also united against the notion of broadly recommending Moderna boosters for anyone as young as 18.

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 eS...