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Today, the U.S. Food and Drug Administration (FDA) issued this final guidance: Electronic Submission Template for Medical Device De Novo Requests. This guidance builds on the guidance Providing Regulatory Submissions for Medical Devices in Electronic Format – Submissions Under Section 745A(b) of the Federal Food, Drug, and Cosmetic (FD&C) Act.
Section 745A(b) of the FD&C Act specifies which medical device submissions will be required to be submitted in electronic format and which submissions are exempt from electronic format requirements. This guidance describes resources, specifically the electronic Submission Template And Resource (eSTAR), to support electronic submission of De Novo requests to the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER).
Starting October 1, 2025, all De Novo Requests, unless exempted, must be submitted as electronic submissions using eSTAR.
Facts about the final guidance
This guidance:
- Describes significant terminology associated with electronic submissions.
- Explains current electronic submission template structure, format, and use.
- Explains electronic submission template waivers, exemptions, and timing.
This guidance represents one of several steps in meeting the FDA’s commitment to develop electronic submission templates to serve as guided submission preparation tools for industry to improve submission consistency and enhance efficiency in the review process.
Questions?
If you have questions about this final guidance, contact the Division of Industry and Consumer Education.
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