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On September 6, 2023, the U.S. Food & Drug Administration (FDA) released three draft guidance documents to provide updated recommendations on the 510(k) Program to “keep pace with the increasing complexity of rapidly evolving...more

9/15/2023  /  510(k) RTA , Draft Guidance , Food and Drug Administration (FDA) , Medical Devices , Public Comment

FDA Issues Draft Guidance for Software Contained in Medical Devices

On November 3, 2021 the FDA issued draft guidance titled “Content of Premarket Submissions for Device Software Functions.” The final version will eventually replace the FDA’s “Guidance for the Content of Premarket Submissions...more

11/10/2021  /  Digital Health , Draft Guidance , FDA Approval , Food and Drug Administration (FDA) , Life Sciences , Medical Devices , Medical Software , Pharmaceutical Industry , Premarket Approval Applications
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