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# De Novo Classification Rule Webinar
- URL: https://www.fdaweb.com/de-novo-classification-rule-webinar/
- Published: 2021-11-24T12:00:00.000Z
- Updated: 2026-09-14T17:23:38.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5150645

FDA has scheduled a 12/14 Webinar for stakeholders interested in learning about the final rule *Medical Device De Novo Classification Process* and associated guidance document updates. An online [notice](https://www.fda.gov/medical-devices/workshops-conferences-medical-devices/webinar-final-rule-medical-device-de-novo-classification-process?ref=fdaweb.com) says the Webinar will: 

- describe the background and history of the de novo program;
- describe the de novo regulations and changes to the de novo review process;
- describe what the updated de novo guidance documents cover; and
- identify the contents of the updated de novo refuse-to-accept checklist and what is required for the acceptance of a de novo request.