The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a guidance document dedicated to the De Novo classification process and requests associated thereto. The document provides an overview of the regulatory framework, clarifications and recommendations regarding the submissions and also describes in detail the review process.

Please note that the provisions of the guidance are non-binding in their legal nature and should be construed as additional recommendations to be taken into consideration by medical device manufacturers and other parties involved.

Commencing the Process

In certain cases, when reviewing a 510(k) submission, the regulating authority could identify that there are no medical devices already placed on the market that are similar enough to the medical device subject to review to establish substantial equivalence. In such a case, the medical device in question is considered non-substantially equivalent (NSE). However, should the FDA determine that the device could still meet the applicable regulatory requirements in terms of safety and effectiveness, it could recommend the manufacturer to follow the De Novo classification pathway. The authority explicitly states that such a recommendation itself should not be construed as confirmation of the fact that the information submitted by the manufacturer in the context of the 510(k) process is sufficient to proceed with the De Novo request. Rather, it confirms that the device subject to review may be eligible for the De Novo classification.

Acceptance Review

First, the regulating authority conducts an acceptance review of each De Novo request received. Such a review is intended to assess the completeness of a request in terms of the information provided. At this stage, the FDA will assess whether the information provided is sufficient to commence the review of a request (a substantive review) and whether it meets any and all applicable requirements. It is further stated the particular acceptance criteria to be applied by the FDA when determining the admissibility of a De Novo request are prescribed by regulation 21 CFR 860.230. In this regard, the Agency also refers to the appropriate guidance “Acceptance Review for De Novo Classification Requests.”

Should, upon conducting the initial acceptance review, the Agency find the De Novo request in question incomplete, it will temporarily suspend the process and duly inform the applicant. The applicant shall provide additional information requested by the FDA not later than 180 calendar days from the date such a notification has been provided. Otherwise, the request will be considered withdrawn.

Under the general rule, it takes 15 calendar days from the date the request was received for the Agency to review it and inform the applicant of the decision taken. Should the regulating authority fail to conduct a review within the aforementioned period, a request would be accepted by default, and the applicant should be notified accordingly.

Substantive Review 

Once the initial acceptance review is completed and the De Novo request has been accepted, the FDA commences the substantive review in order to determine the applicable classification for the medical device in question. According to the guidance, FDA intends to analyze whether an existing legally marketed device of the same type exists (e.g., whether [submitted for review] device likely falls under an existing classification regulation), including whether a predicate was established through the De Novo classification process. Should the authority identify a similar device already placed on the market, that could be referred to as a predicate, or determine that the medical device in question meets classification criteria for one of the classes of medical devices under existing risk-based classification, the medical device subject to review would be deemed as not eligible for classification under the De Novo framework, and the appropriate request would be declined accordingly. It is stated that the authority will duly notify the applicant about any grounds for declining the request. If the medical device formally meets criteria relevant for Class III medical devices, but the Agency finds it acceptable to provide a reasonable assurance of safety and effectiveness, the device could be reclassified and assigned to a lower class under the applicable risk-based classification. 

Should in the course of the substantive review, the FDA identify that the information reasonably needed to complete the review is missing, it is entitled to request such information to be provided by issuing an additional information (AI) letter. According to the applicable regulations, once an AI letter is issued, the review timeline suspends, and the applicant has 180 calendar days to provide additional information requested by the Agency. Otherwise, the request would be considered withdrawn. In such a case, to commence a review, the applicant would have to submit a new De Novo request and commence the process from the very beginning. 

Apart from the situations described above, the FDA may decline a De Novo request for various reasons. In such a case, the appropriate notice would be provided to the applicant to inform them about the grounds behind the decision taken. It is also important to mention that while the medical device of which the De Novo request has been declined should not be placed on the market, the applicant would have two options available:

  • To submit an application for premarket approval (PMA) under section 515 of the FD&C Act; or
  • To collect additional information to address the issues and submit a new De Novo request that includes the additional information. 

If none of the reasons to decline a De Novo request are applicable, the Agency will grant the appropriate request and notify the applicant accordingly. The order to be issued by the FDA in this regard would contain information about the classification of a medical device question, as well as references to the special controls (in the case of Class II medical devices). According to the applicable legislation, the interested party is allowed to supply the medical device in question from the date such order has been granted, while the device itself could be used as a predicate device for future 510(k) submissions. As it is stated in the guidance, a De Novo request for a device that receives marketing authorization via the De Novo classification process is referred to as having been “granted” (similar to “PMA approved” and “510(k) cleared”). 

In summary, the present FDA guidance provides additional information and clarifications regarding the De Novo classification process. The document describes in detail the approach FDA applies when reviewing a De Novo request, including the initial acceptance review and substantive review, and also outlines the situations when a request could be declined. 


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