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# Info Collection on Device De Novo Requests
- URL: https://www.fdaweb.com/info-collection-on-device-de-novo-requests/
- Published: 2024-05-28T12:00:00.000Z
- Updated: 2026-09-14T14:31:56.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5157061

*Federal Register* notice: FDA is seeking comments on an OMB information collection extension entitled “De Novo Classification Process (Evaluation of Automatic Class 3 Designation) — 21 CFR Part 860, Subpart D.” The collection supports agency regulations that establish a “De Novo” classification process and govern format and content elements for De Novo device classification requests, as well as withdrawal of the requests. They also explain FDA procedures for acceptance, review, and granting or denying a request. To view the notice, click [here](https://public-inspection.federalregister.gov/2024-11743.pdf?ref=fdaweb.com).