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510(k) Modernization 2023 - Healthcare

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

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United Health Products Reports on FDA Application Status

United Health Products Reports on FDA Application Status
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Progress of Pre-Submissions for Medical Devices Now Trackable Through CDRH Portal - Medical device manufacturers must submit applications for certain classes of medical. ....

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Medical device 510(k) submissions must be electronic by October 2023, FDA says | Hogan Lovells

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). ....

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FDA advisers to consider J&J Covid-19 boosters after endorsing Moderna's

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

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