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Home » FDA draft guidance for 510(k) clinical data draws fire
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FDA draft guidance for 510(k) clinical data draws fire

Dec. 15, 2023
By Mark McCarty
The FDA’s ongoing efforts to modernize the 510(k) program produced three draft guidances in the waning days of fiscal year 2023, one of which is a draft for the scenarios in which clinical data would be required for a 510(k) application.
BioWorld MedTech Regulatory U.S. FDA

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