The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a guidance document describing De Novo Classification Requests in the context of the effect on the FDA review clock and goals. The document continues the cycle of guidance documents dedicated to De Novo Classification Requests. The document constitutes a modified version of the respective guidance initially issued in October 2017. Due to its legal nature, the document is not intended to introduce new rules or requirements the parties involved should follow, but to provide additional clarifications and recommendations to be considered. Moreover, an alternative approach could be applied, provided such an approach complies with the respective regulatory requirements and has been agreed with the authority in advance. 

Regulatory Background 

First of all, the FDA mentions that the final rule on the De Novo Classification Process has been issued by the authority on October 5, 2021. Hence, the present guidance has been amended to align provisions contained therein with the recent changes to the regulatory framework. As it is stated by the FDA, the present guidance highlights the following aspects:

  • The different FDA actions that may be taken on De Novo requests;
  • The effect each action has on goal under MDUFA IV for De Novo requests received in FY 2018-2022; and
  • The different industry actions that may be taken on De Novo requests.

FDA Actions: Key Points 

The document further describes the actions that could be taken by the authority about De Novo’s requests. As described in respective guidance documents, the Agency commences the substantive review of the request received upon successful acceptance. By the applicable regulations, the authority should take one of the following actions:

  • Issue an order granting a De Novo request for classification (granting order);
  • Issue an order declining a De Novo request for classification (decline order); or 
  • Issue a request for additional information (AI request). 

As explained in the guidance, should the applicant fail to provide additional information requested by the FDA within 180 calendar days from the date the request has been provided, the authority will deem the initial request as withdrawn. Should this be the case, the authority will notify the applicant accordingly. As it is mentioned in the guidance, such notice is usually referred to as a “deletion letter”. According to the guidance, the first two actions are considered MDUFA decisions. 


Granting the Request 

The first decision the FDA can make is to grant the De Novo request to classify the medical device in question. In particular, the appropriate notice provided by the authority will explicitly state that the device subject to classification should be assigned to the particular class under the applicable risk-based classification. Hence, the entity responsible for the medical device is allowed to place it on the market, provided all the requirements related to the category are met. The particular criteria to be applied by the FDA when determining whether the decision to grant a request or to decline it should be made are prescribed by the respective legislation. According to the guidance, an order to grant a De Novo request shuts off the review clock meaning that the review procedure is completed, as such a decision of the authority is deemed final. 


Declining the Request 

Should the authority, upon review, identity that the medical device in question is either not eligible for De Novo classification, or the information provided in the request confirms the device should be assigned to class III, the decision to decline the request will be issued, and the applicant will be informed accordingly, meaning that the initial classification of the device remains unchanged. 

The guidance further provides a list of situations in which the authority may decide to decline the request. These situations include, inter alia, the following ones:

  • The product in question is not a class I or class II medical device;
  • The request itself contains incorrect information;
  • The labeling of the device does not meet the applicable regulatory requirements;
  • The product in question falls outside the scope of the definition of a medical device, and is not a combination product;
  • There is a similar medical device already placed on the market under the PMA framework;
  • There is a similar medical device already placed on the market, which could be used as a predicate to determine the applicable classification; 
  • A nonclinical study the request refers to does not meet the applicable requirements;
  • A clinical study supporting the request has been carried out not in compliance with the requirements;
  • A clinical or nonclinical study necessary to demonstrate that general controls or general and special controls provide reasonable assurance of safety and effectiveness (i) has not been completed per the study protocol, or (ii) deficiencies related to the investigation and identified in any request for additional information under 21 CFR 860.240(b)(1) have not been adequately addressed; or 
  • The applicant requesting a De Novo classification has implemented significant changes to the device in question in terms of indications for use or characteristics. 

As it is further explained in the guidance, the regulating authority would assess all the factors, so its decision could be based on several factors from the list provided hereinabove. For instance, the request could be declined if the information provided by the applicant is insufficient, even if the device itself is eligible for De Novo classification. The same decision will be made by the FDA in case it will determine the controls implemented by the manufacturer are insufficient to ensure safety for the risks associated with the device. As in the case of the order to grant, the order to decline is a final one and stops the review clock. 


Request for Additional Information 

As it was mentioned before, the regulating authority is entitled to request additional information, should it be reasonably necessary to assess the case. The appropriate notice will be provided to the applicant if the authority will determine that the information provided is insufficient to make a decision. The notice will outline the information required, and be provided via email. In terms of review time, the Agency states that once the request for additional information has been issued, the review process will be paused for the period during which the applicant should provide additional information requested. Once such information will be provided by the applicant, the review process will resume. 

The Agency additionally emphasizes that the applicant is allowed to submit additional information at its initiative. In such a case, the reference to the initial De Novo request should be made by indicating the respective number, and the appropriate justification for providing additional information should be communicated to the FDA. 

In summary, the present FDA guidance describes the way various actions are taken concerning De Novo classification requests impact the review timeline. The document highlights the most important aspects to be taken into consideration by medical device manufacturers to ensure compliance with the applicable regulatory requirements. 




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