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    STAT+: FDA proposes changes to key approval pathway for medical devices, five years after promising

    The FDA issued new guidelines clarifying the way they plan to evaluate medical devices that go through the controversial 510(k) pathway.
    by Lizzy Lawrence Sep 12, 2023 1 minute
    Last week, the FDA released a trio of guidelines clarifying the way they plan to evaluate devices that go through the 510(k) pathway.

    Five years after promising to fix a flawed regulatory pathway widely used by medical device manufacturers, the Food and Drug Administration has

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