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# 2 FDA Guidances on De Novo Device Requests
- URL: https://www.fdaweb.com/2-fda-guidances-on-de-novo-device-requests/
- Published: 2019-09-09T12:00:00.000Z
- Updated: 2026-09-15T01:48:33.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5144946

FDA has issued two guidances related to medical device de novo classification requests. The first [guide](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/fda-and-industry-actions-de-novo-classification-requests-effect-fda-review-clock-and-goals?ref=fdaweb.com), “FDA and Industry Actions on De Novo Classification Requests: Effect on FDA Review Clock and Goals,” describes·different FDA actions that may be taken on De Novo requests and the effect each action has on goals under the user fee performance goals. It also discusses the different industry actions that may be taken on de novo requests.

The [second guide](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/user-fees-and-refunds-de-novo-classification-requests?ref=fdaweb.com), “User Fees and Refunds for De Novo Classification Requests,” identifies the types of de novo requests subject to user fees and the exceptions to being assessed user fees. The document also discusses the actions that may result in refunds of user fees that have been paid.