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# Guidance for Using De Novo Classification Process
- URL: https://www.fdaweb.com/guidance-for-using-de-novo-classification-process/
- Published: 2017-10-27T12:00:00.000Z
- Updated: 2026-09-14T22:58:40.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5139989

FDA has posted a guidance on “De Novo Classification Process (Evaluation of Automatic Class III Designation)” that provides recommendation on how to use the process to get a device classified and on the market. The pathway is intended for sponsors that believe their device is appropriate for classification into Class 1 or Class I and there is no legally marketed predicate device. To view the guidance, click [here](https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM080197.pdf?ref=fdaweb.com).