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# De Novo Device E-filing Guide
- URL: https://www.fdaweb.com/de-novo-device-e-filing-guide/
- Published: 2023-09-29T12:00:00.000Z
- Updated: 2026-09-14T18:59:26.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5155451

*Federal Register* notice: FDA is making available a draft guidance entitled “‘Electronic Submission Template for Medical Device De Novo Requests.’’ The document is part of FDA’s commitment to develop electronic submission templates to improve submission consistency and enhance efficiency in the review process. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2023-09-29/pdf/2023-21405.pdf?ref=fdaweb.com).