Paige Cappelli

Knobbe Martens

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FDA Releases Draft Guidances on 510(k) Submissions

On September 6, 2023, the U.S. Food & Drug Administration (FDA) released three draft guidance documents to provide updated recommendations on the 510(k) Program to “keep pace with the increasing complexity of rapidly evolving...more

9/15/2023  /  510(k) RTA , Draft Guidance , Food and Drug Administration (FDA) , Medical Devices , Public Comment
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