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# 510(k), De Novo, PMA Review Clock Guidances
- URL: https://www.fdaweb.com/510-k-de-novo-pma-review-clock-guidances/
- Published: 2022-10-04T12:00:00.000Z
- Updated: 2026-09-14T18:01:41.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5152891

FDA has published three guidances describing agency and industry actions on three types of medical device submissions – *de novo*, 510(k) and PMA – and the effect the actions have on the FDA review clock and goals. The documents cover performance goals negotiated as part of the MDUFA 5 reauthorization.

The *de novo* [guidance](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) describes the different actions that may be taken on de novo requests; the effect each action has on goals under MDUFA 4 for *de novo* requests received in FY 2018-2022; the effect each action has on goals under MDUFA 5 for *de novo* requests received in FY 2023-2027; and the different industry actions that may be taken on *de novo* requests.

Guidances with similar descriptions were published for [510(k)](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/fda-and-industry-actions-premarket-notification-510k-submissions-effect-fda-review-clock-and-goals?ref=fdaweb.com) and [PMA](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/fda-and-industry-actions-premarket-approval-applications-pmas-effect-fda-review-clock-and-goals?ref=fdaweb.com) submissions.