FDA Proposes Updates to 510(k) Path

On September 6, 2023, the FDA released three draft guidance documents that seek to “modernize” the 510(k) premarket notification process.  Ever since the FDA first proposed “transformative new steps” to the program in 2018, the agency has promised to further update the 510(k) clearance pathway in an effort to better balance technological innovation and patient safety.  In …

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Will Heaston Member since October 19, 2023

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