Devices

FDA Proposes De Novo Pathway Changes

David McFarland

— 2 min read
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FDA has issued a De Novo Classification Proposed Rule that, when finalized, will establish procedures and criteria for the de novo classification process and become part of the Medical Device Classification Procedures. The document says the new requirements “are intended to ensure the most appropriate classification of devices consistent with the protection of the public health and the statutory scheme for device regulation, as well as to limit the unnecessary expenditure of FDA and industry resources that may occur if devices for which general controls or general and special controls provide a reasonable assurance of safety and effectiveness are subject to premarket approval.”

The proposed rule provides that: 

  •          a person may submit a de novo request after submitting a 510(k) and receiving a not substantially equivalent determination;
  • ·        a person may submit a de novo request without first submitting a 510(k) if the person determines that there is no legally marketed device upon which to base a determination of substantial equivalence;
  •          FDA will classify devices according to the classification criteria in the Federal Food, Drug, and Cosmetic Act;
  •          FDA will classify devices by written order;
  •          a de novo request includes administrative information, regulatory history, device description, classification summary information, benefits and risks of device use, and performance data to demonstrate reasonable assurance of safety and effectiveness;
  •          FDA may refuse to accept a de novo request that is ineligible or is incomplete on its face;
  •          after a de novo request is accepted, FDA will begin a substantive review of the request that may result in either FDA requesting additional information, issuing an order granting the request, or declining the de novo request; and
  •          FDA may decline a de novo request if, among other things, the device is ineligible or insufficient information is provided to support de novo classification.

FDA commissioner Scott Gottlieb says the goal of the new proposal “is to make the de novo pathway significantly more efficient and transparent by clarifying the requirements for submission and procedures 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.”

 

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