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Final Guidance Sets Date For Mandatory De Novo Electronic Submissions

 
• By Brian Bossetta

The Food and Drug Administration’s final guidance outlines the agency’s thinking for sponsors submitting de novo requests electronically, which they must starting in October 2025.

Electronic Submissions
• Source: Shutterstock

The Food and Drug Administration has published a final guidance document to help sponsors prepare to submit de novo requests electronically. The document, “Electronic Submission Template for Medical Device De Novo Requests,” describes the technical standards associated with preparation of the electronic submission template, or eSTAR, for de novo classification requests solely in electronic format.

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