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

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 The FDA will set a date for de novo requests within two years, according to a separate draft guidance.