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# 4 Device De Novo Guidances Revised
- URL: https://www.fdaweb.com/4-device-de-novo-guidances-revised/
- Published: 2021-10-05T12:00:00.000Z
- Updated: 2026-09-14T17:17:49.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5150298

FDA has revised four guidance documents based on a final rule on the medical device de novo classification process. For example, the guidance [*Acceptance Review for De Novo Classification Requests: Guidance for Industry and Food and Drug Administration Staff*](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/acceptance-review-de-novo-classification-requests?ref=fdaweb.com)provides further detail about the types of information FDA believes are necessary to conduct a substantive review for a de novo request, as well as the recommendations regarding the acceptance review process. The other guidances with revisions are:

- [*De Novo Classification Process (Evaluation of Automatic Class III Designation): Guidance for Industry and Food and Drug Administration Staff*](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/de-novo-classification-process-evaluation-automatic-class-iii-designation?ref=fdaweb.com)
- [*FDA and Industry Actions on De Novo Classification Requests: Effect on FDA Review Clock and Goals: Guidance for Industry and Food and Drug Administration Staff*](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)
- [*User Fees and Refunds for De Novo Classification Requests : Guidance for Industry and Food and Drug Administration Staff*](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/user-fees-and-refunds-de-novo-classification-requests?ref=fdaweb.com)