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October 08, 2021

Health Law Weekly

FDA Issues Final Rule on “De Novo” Classification for Low-Risk Medical Devices

  • October 08, 2021

The Food and Drug Administration (FDA) published October 5 a final rule (86 Fed. Reg. 54826) to implement regulations for a “de novo” classification process aimed at offering manufacturers a less burdensome application pathway to market for lower-risk medical devices under the Food, Drug, and Cosmetic Act (FD&C Act).

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