The FDA has published the De Novo Classification Proposed Rule and, if finalized, would establish certain procedures and criteria for the organization’s De Novo pathway—used to review new, low- to moderate-risk medical devices—and become part of the Medical Device Classification Procedures (21 CFR Part 860).

If finalized, the proposed regulations and requirements of the new rule will “provide structure, clarity and transparency” for the De Novo classification process and include processes and criteria for accepting, granting, declining and withdrawing De Novo requests, according to a recent FDA press release.  

The announcement follows steps publicized by the FDA on Nov. 26 to modernize and finalize its 510(k) clearance pathway for the approval of medical devices into the market as well as related efforts in April.

The proposed rule also supports greater efficiency in the De Novo classification process outlined in the Medical Device User Fee Amendments 2017 (MDUFA IV) Commitment Letter from the FDA and industry representatives. The proposed rule is available for public comment. The FDA hopes that, if finalized, it and previous efforts will encourage more developers to use the pathway for novel devices.  

“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, MD, said in the prepared statement. “The proposed regulation we’re issuing today—as well as those steps that we announced last week—will help the FDA regulate new technologies in ways that enable us to protect patient safety while promoting innovations that can advance peoples’ health and function.”