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December 10, 2018

FDA Proposes Procedures and Criteria for De Novo Pathway for Medical Devices

December 5, 2018—The FDA announced it has published the De Novo Classification Proposed Rule. If finalized, the rule will establish procedures and criteria for the De Novo classification process and become part of the Medical Device Classification Procedures (21 CFR Part 860).

The proposed rule is available for public comment and will not be in effect until finalized. The FDA stated that it welcomes comments from stakeholders regarding this important step in bringing greater structure, clarity, and efficiency to medical device regulation. The agency noted that the De Novo pathwayis used for the review of novel low- to moderate-risk devices for which general controls, or general and special controls, provide a reasonable assurance of safety and effectiveness, but for which there is no existing predicate to use in determination of substantial equivalence.

According to FDA, the proposed rule would, if finalized, facilitate appropriate classification of new types of medical devices. For example, the proposed regulations and requirements will provide structure, clarity, and transparency on the De Novo classification process, including requirements related to the format and content of De Novo requests as well as processes and criteria for accepting, granting, declining, and withdrawing De Novo requests.

On November 26, the FDA announcedproposed changes intended to modernize the 510(k) clearance pathway to keep pace with the increasing complexity of rapidly evolving technology.

In the latest announcement, FDA Commissioner Scott Gottlieb, MD, commented, “The De Novo pathway for novel medical devices allows the FDA to conduct a rigorous review of new technologies so that patients have timely access to safe and effective medical devices to improve their health. At the same time, the FDA is modernizing its 510(k) pathway, which is used for clearance of low- to moderate-risk devices that are substantially equivalent to a device already on the market. The De Novo pathway provides a vehicle for establishing new predicates that can reflect modern standards for performance and safety and can serve as the basis for future clearances. 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. As a result, we expect to see more developers take advantage of the De Novo pathway for novel devices. In addition, we also believe that more devices will use the De Novo pathway as we take new steps to promote the use of more modern predicates in the 510(k) process. 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.”

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