Blog Post

De Novo Classification Final Rule to Take Effect Next Year

MoFo Life Sciences

20 Dec 2021

On Tuesday, December 14, 2021, the U.S. Food and Drug Administration (FDA) hosted a webinar discussing the final rule, Medical Device De Novo Classification Process, and associated guidance document updates. The final rule, which will take effect on January 3, 2022, codifies the medical device De Novo classification process by adding new regulations at 21 CFR Part 860, Subpart D. Dr. Peter Yang, De Novo Program Lead at the FDA Center for Devices and Radiological Health (CDRH), led the webinar. Dr. Yang described the new De Novo regulations, explained how the regulations may or may not change the current De Novo review process, and answered questions from various interested parties.

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