FDA details switch to electronic filings for 510(k), de novo submissions

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via The Food and Drug Administration has published two guidance documents on the structure of electronic filings for 510(k) and de novo clearances.
In a final guidance issued on Monday, the FDA identifies Oct. 1, 2023 “as the date on which the 510(k) electronic submission requirements will take effect.” The FDA will set a date for de novo requests within two years, according to a separate draft guidance.

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