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# Guide on Acceptance Review for De Novo Devices
- URL: https://www.fdaweb.com/guide-on-acceptance-review-for-de-novo-devices/
- Published: 2019-09-06T12:00:00.000Z
- Updated: 2026-09-15T01:48:16.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5144935

FDA has issued a final guidance entitled “Acceptance Review for De Novo Classification Requests.” The document is intended to provide clarity about the de novo pathway and explains the procedures and criteria the agency will use to determine if such a request meets a minimum threshold of acceptability and should be accepted for substantive review. It also includes a de novo acceptance checklist and a recommended content checklist. This guidance was mandated under FDA’s [Medical Device User Fee Amendments of 2017 (MDUFA IV) commitment](http://s2027422842.t.en25.com/e/er?utm%5Fcampaign=09-06-2019%20Final%20Guidance%20on%20Acceptance%20Review%20for%20De%20Novo%20Classification%20Requests&utm%5Fmedium=email&utm%5Fsource=Eloqua&s=2027422842&lid=9544&elqTrackId=F80FC51281905D7B3795F475A19A7BDB&elq=26b93867222f44679afc0c3b6555cf71&elqaid=9351&elqat=1).