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 regulatory framework associated thereto.

Due to its legal nature, the document is not intended to introduce new rules and requirements itself but rather to provide additional clarifications and recommendations to be considered by the parties involved. The authority additionally states that an alternative approach could be applied, provided such an approach complies with the applicable regulatory requirements and has been approved by the authority in advance. Accordingly, the recommendations the guidance contains are non-binding.

Regulatory Background 

The present FDA guidance is intended to provide additional clarifications regarding the way an interested party should file an application for De Novo classification (“De Novo request”) and also describes the regulatory procedures associated thereto. Clarifications provided in the guidance are based on the provisions of the Federal Food, Drug, and Cosmetic (FD&C) Act, which constitutes a basis for the applicable regulatory framework. In particular, the guidance describes in detail the approach to be applied in the case of Class I or Class II classification for medical devices for which general controls or general and special controls provide a reasonable assurance of safety and effectiveness, but for which there is no legally marketed predicate device. The authority additionally emphasizes that Class III medical devices are not eligible for the De Novo classification process. According to the applicable legislation, determination of the respective class of the device should be based on the risks associated thereto, as well as on the special controls to be duly developed and implemented by its manufacturer in order to ensure its safety and effectiveness when used for the intended purpose. 

However, there are situations when a new medical device is assigned to Class III automatically, by default. This applies in cases when there is no similar medical device already placed on the market to be used as a predicate. At the same time, the actual risks associated with such devices could be lower than those corresponding to Class III medical devices. Hence, an unnecessary regulatory burden could arise. In order to avoid this, the “De Novo classification process” has been introduced. Under the appropriate framework, the party responsible for such product is entitled to submit a De Novo request with regard to a medical device that has been automatically classified as a Class III product resulting in additional regulatory requirements to be followed. The authority additionally emphasizes that according to the applicable legislation, in order to submit a De Novo request, a device first had to be found not substantially equivalent (NSE) to legally-marketed predicate devices through a premarket notification (510(k)).

At the same time, the applicable legislation provides an alternative pathway under which determination as not substantially equivalent to a marketed device is not required. Thus, if the medical device manufacturer has reasonable grounds to consider its product Class I or Class II medical device, while there are no similar medical devices placed on the market, the manufacturer is entitled to submit a De Novo request. The procedure of submitting De Novo requests without determining NSE is referred to as “Direct De Novo.” 

The latest update of the regulatory requirements for the De Novo Classification Process took place on October 5, 2021. According to the guidance, this final rule will add new regulations at 21 CFR Part 860, Subpart D — De Novo Classification that describes the procedures and criteria FDA will use in assessing whether a request for an evaluation of automatic class III designation (De Novo classification request or De Novo request) contains the information necessary to permit a substantive review. The present document is intended to provide additional clarifications regarding the way the new provisions should be interpreted. 

De Novo Classification Process 

The document further describes in detail the De Novo Classification Process and regulatory requirements associated thereto. According to the guidance, the De Novo request should contain detailed information regarding the medical device in question, as well as a sufficient justification and reasoning for the classification the manufacturer is requesting. Under the general rule, the regulating authority should make its determination no longer than 120 days from the date a complete request has been received. Should the necessary requirements be fulfilled, the De Novo request will be granted by the FDA. Consequently, the regulatory status of a product would be Class I or Class II medical device. It is stated that the granting of the De Novo request allows the device to be marketed immediately, creates a classification regulation for devices of this type, and permits the device to serve as a predicate device. The appropriate notice will be published in the Federal Register. 

However, should the FDA decide to decline the De Novo request, the device should be classified as a Class III medical device, and all the relevant regulatory requirements should be applied. In such a case, the device would be allowed for marketing only if:

  • The device is found substantially equivalent to an existing legally marketed Class I, Class II, or preamendments device;
  • The device is reclassified under section 513(f)(3) of the FD&C Act;
  • A PMA is approved; or 
  • A new De Novo request is granted. 

De Novo Classification Process: Limitations of Use

In order to assist medical device manufacturers and other parties involved in applying the rules described herein, the authority also provides additional clarifications regarding the applicability of the De Novo Classification. First, the Agency mentions that this approach could be followed if there are no similar medical devices (products of the same type) already placed on the US market. Hence, it is not reasonably possible to make references to a predicate device. If the device in question has already passed a 510(k) review, it could be found eligible for a De Novo request if it was found NSE due to:

  • The lack of an identifiable predicate device, 
  • A new intended use, or 
  • Different technological characteristics that raise different questions of safety and effectiveness. 

At the same time, the authority explicitly states that should the NSE determination be based on a failure of the applicant to provide sufficient information demonstrating substantial equivalence to a predicate device, the De Novo Classification Process should not be applied. 

In summary, the present FDA guidance provides an overview of the principles of the De Novo Classification Process. The document outlines the main eligibility criteria and provides additional clarifications regarding the applicable regulatory requirements set forth under existing legislation. 


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