The FDA has issued its final guidance on the "Electronic Submission Template for Medical Device De Novo Requests." This guidance builds upon the previously established document, "Providing Regulatory Submissions for Medical Devices in Electronic Format – Submissions Under Section 745A(b) of the Federal Food, Drug, and Cosmetic (FD&C) Act."
Under Section 745A(b) of the FD&C Act, the FDA specifies which medical device submissions are required to be submitted electronically and identifies exemptions. This latest guidance introduces the electronic Submission Template And Resource (eSTAR) as the primary tool for submitting De Novo requests to the CDRH or CBER.
Starting October 1, 2025, all De Novo requests—unless exempted—must be submitted electronically using eSTAR.
