FDA Proposes Changes to the De Novo Pathway


On Tuesday, December 4th, FDA published the De Novo Classification Proposed Rule. If finalized, the rule would establish procedures for the De Novo classification process by facilitating appropriate classification for new medical devices. The proposed rule provides structure, clarity, and transparency for the De Novo process.  It establishes rules for the submission and withdrawal of requests for De Novo classification and creates criteria that the FDA will use when accepting, granting, declining, or withdrawing requests.

What is a De Novo request?

The De Novo pathway provides sponsors with a way to classify novel, low- to moderate-risk medical devices “or 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.”  The De Novo classification is considered a risk-based classification process and Do Novo determinations are made by FDA on a case by case basis.  However, if obtained, a De Novo classification allow sponsors to obtain FDA approval of their novel device without going through the time-consuming and expensive PMA process.  Since the creation of the process, 235 safe and effective medical devices have obtained a De Novo determination from the FDA.

History of the De Novo Classification Process

The De Novo classification pathway was established in 1997 through the Food and Drug Administration Modernization Act (FDAMA).  Prior to FDAMA, regardless of their level of risk, new devices without a predicate were classified as class III medical devices and therefore subject to premarket approval (PMA). The De Novo pathway was created to limit unnecessary expenditure of FDA and industry resources by allowing novel, low to moderate risk devices without a predicate, the ability to be classified as a Class I or Class II device through the De Novo classification process.

In 2012, the Food and Drug Administration Safety and Innovation Act (FDASIA) was passed, helping to further streamline the and increase the efficiency of the De Novo pathway.

On October 30, 2017, FDA issued a final guidance document that provides recommendations regarding the submission and review of De Novo requests. This document contains the information required to submit a complete De Novo request, as well as recommendations for successful interactions with FDA during the review process.

Proposed Components of Improved Pathway

FDA Commissioner Scott Gottlieb, M.D., commented on the proposed rule stating that FDA’s “goal is to make the De Novo pathway significantly more efficient and transparent by clarifying the requirements for submission and processes for review.” The proposed rule provides that:

  • A person may submit a De Novo request after submitting a 510(k) and receiving a not substantially equivalent (NSE) determination
  • A De Novo request may be submitted without a 510(k) submission if the Sponsor determines that a legally marketed device with substantial equivalence does not exist
  • FDA will classify devices according to the criteria determined by the FD&C Act
  • FDA will classify devices by written order
  • De Novo requests will include administrative information, regulatory history, device description, classification summary information, risks and benefits of using the device, and performance data to demonstrate reasonable assurance of safety and effectiveness
  • FDA reserves the right to refuse to accept any request that is ineligible or incomplete on its face
  • FDA will conduct a substantive review of the De Novo request that may result in the Agency requesting additional information, issuing an order to grant the request, or denying the request
  • The request may be denied by the FDA if the information is insufficient or the device is ineligible to support De Novo classification

If finalized, the rule would implement the De Novo process under the FD&C Act. In addition to the recently announced modern changes to the 510(k) medical device approval process, the proposed rule will help promote innovative techniques to advance patient health. The FDA encourages comments from persons with significant interest in medical device regulation. FDA is seeking feedback on the proposed rule and is asking that all comments be submitted by March 7, 2019.

Are you in the process of developing a medical device for submission to FDA? Do you think your device may be eligible for the De Novo pathway? We can assist with all regulatory aspects of your medical device.  To learn more about our medical device consulting services, contact us today.