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# Guide on De Novo Device Acceptance Review
- URL: https://www.fdaweb.com/guide-on-de-novo-device-acceptance-review/
- Published: 2019-09-10T12:00:00.000Z
- Updated: 2026-09-15T01:48:41.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5144963

*Federal Register* notice: FDA has made available a final guidance entitled “Acceptance Review for De Novo Classification Requests.” The document explains the procedures and criteria FDA intends to use in assessing whether a request for an evaluation of automatic Class III designation (De Novo classification request or De Novo request) meets a minimum threshold of acceptability and should be accepted for substantive review. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2019-09-09/pdf/2019-19350.pdf?ref=fdaweb.com).