FDA Releases Proposed Rule on De Novo Pathway for Novel Devices

December 10, 2018

The FDA published a proposed rule that would further streamline the agency’s De Novo classification process.

If finalized in its current form, the rule would establish new procedures for submitting and withdrawing De Novo requests, along with procedures and criteria for the agency to accept, review, grant and decline them.

“Our goal is to make the De Novo pathway significantly more efficient and transparent by clarifying the requirements for submission and our processes for review,” FDA Commissioner Scott Gottlieb said.

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