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FDA Proposes to Clarify and Formalize the De Novo Classification Process for Medical Devices

By Matthew Sprankle on January 16, 2019
Posted in FDA, Medical Device
FDA-Developments-MEME

On December 7, 2018, the U.S. Food and Drug Administration (“FDA”) published a proposed rule (“Proposed Rule”) that, if finalized, would clarify the de novo classification process for medical devices, including (1) the format and contents of a de novo request and (2) the criteria for accepting or denying a de novo request.…

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