The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of medical devices, has published a guidance document dedicated to the actions related to De Novo classification requests in the context of their effect on FDA review clock and goals. The document continues the cycle of FDA guidance documents describing various aspects related to De Novo classification requests, such as acceptance review or FDA actions. The present document constitutes an updated version of the respective guidance initially published in October 2017. It is important to mention that FDA guidance documents are non-binding, and are intended to provide additional clarifications regarding the applicable regulatory framework, as well as recommendations to be considered by medical device manufacturers and other parties involved. Moreover, an alternative approach could be applied, provided such an approach complies with existing regulatory requirements and has been agreed with the authority in advance. The authority also reserves the right to amend the present guidance document and recommendations provided therein, should it be reasonably necessary to reflect changes to the applicable legislation.

Regulatory Background 

First of all, the FDA refers to a final rule on the De Novo Classification Process issued earlier in October 2021. The aforementioned rule is intended to establish a procedure for reviewing the requests for evaluation of automatic Class III designation, especially in terms of the information that is required to conduct such a review. 

As further explained by the Agency, the scope of the present guidance covers:

  • The different FDA actions that may be taken on De Novo requests;
  • The effect each action has on goals 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. 

As it was described in respective guidance documents, the authority commences the substantive review of a De Novo request only upon its successful completion of the acceptance review, during which the Agency assesses the completeness of the information provided for determining the classification of a product in question. The actions to be taken by the authority upon completion of a substantive review include the following ones:

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

Should the applicant fail to provide the authority with the information requested within 180 calendar days from the days such a request has been issued, the initial application will be deemed withdrawn, and the applicant would have to commence the process from the very beginning. In such a case, the authority will issue a “deletion letter” notifying the applicant about the change in the status of the application due to the lack of response. 

Class I Software Medical Devices 

Class I is the lowest class under the applicable classification system and applies to the devices with the lowest risk associated thereto. Hence, the applicable regulatory controls are quite low as well. In the case of software-based medical devices, this class applies for the devices that are:

  • Intended to monitor the state or progression of a disease;
  • Providing information that does not indicate if an individual may be in danger;
  • Associated with a low public health risk. 

Class IIa Software Medical Devices 

This category applies to medical devices associated with medium risk. An example provided by the TGA describes diabetes diagnosis software that is intended to be used by a healthcare professional. Thus, such a product is a Class IIa medical device as the device provides information to a relevant health professional to inform the diagnosis of a serious disease. This category also covers risk prediction software, as well as the tools that record data from a patient monitor or images directly from an MRI scanner (provided that such software does not impact the operations of a scanner itself). 

Class IIb Software Medical Devices 

This category applies to medical devices associated with medium-high risk. For instance, such classification should be applied to a product that is intended to analyze a cardiac MRI in order to provide information used in making diagnoses of related diseases. As in the previous example, the software is intended to provide information to healthcare professionals only. As described in the guidance, Class IIb applies to medical software that is intended by the manufacturer (the software developer) to provide information to a relevant health professional to inform the diagnosis of a serious disease. Other examples of Class IIb products include tools intended to be used to diagnose an acute arterial occlusion due to the severity of potential consequences of this disease if the necessary treatment is not applied. This category also covers software products that are intended to provide recommendations for treatment or intervention on the basis of input data (e.g., a coronary angiogram). As in the previous cases, such software should be used only by healthcare professionals. Consequently, a Class IIb software-based medical device is the one that is intended to:

  • Recommend a treatment or intervention to a relevant health professional for the purposes of making a decision about the treatment or intervention; and 
  • Be used in cases when the absence of a treatment or a treatment itself could result in severe health deterioration or other adverse consequences. 

The same classification applies to wearable devices intended to collect and analyze data for screening for serious heart diseases, as well as questionnaire apps intended to analyze the information provided by a patient and provide a diagnostic output. 

De Novo Performance Goals for MDUFA IV

The guidance further describes each of the actions the Agency may take and explains the way these actions impact the review clock and also provides additional clarifications on De Novo’s performance goals. As described in the document, the aforementioned goals include, inter alia, the following ones:

  • Most De Novo requests are subject to a user fee;
  • FDA will issue draft and final guidance that includes a submission checklist to facilitate a more efficient and timely review process;
  • De Novo requests are subject to a one-tier MDUFA decision goal (there are no “cycle” (or review cycle) goals for interim actions); and
  • For De Novo requests for which an MDUFA decision has not been rendered within 180 days, at the requester’s request and resources permitting, but not to the detriment of meeting the quantitative review timelines, FDA will discuss with the requester all outstanding issues with the submission preventing FDA from reaching a decision. 



Under the general rule, eCopy requirements should be applied to De Novo requests as well. In this regard, the authority refers to the appropriate guidance document dedicated to the eCopy Program for Medical Device Submissions. The authority also emphasizes the importance of a fee to be paid by the applicant (requester). In particular, it is stated that the request will not be forwarded to the respective department for review unless such a fee has been paid. 


Acceptance Review 

As prescribed by 21 CFR 860.230, once a De Novo classification request has been received, the authority shall complete an acceptance review no later than 15 calendar days from the date a request has been initially received. In the course of this review, the authority will assess whether the request submitted contains all the information necessary to proceed with substantive review. Should the Agency decide to refuse the request, the applicant will be notified accordingly within the same period. When notifying about a refusal, the authority will specify the particular grounds for such a decision. In such a case, the review process will be paused until the applicant will provide the information required. The FDA additionally emphasizes that the aforementioned procedure applies to initial acceptance review, but should not be applied on later stages when additional deficiencies could be identified. 


Substantive Review 

Upon successful completion of an acceptance review, the Agency will commence a substantive review to assess the subject matter. The appropriate procedure is prescribed by 21 CFR 860.240(a). When describing the way the authority may interact with the applicant in the course of a substantive review, the guidance applies the concept of a Substantive Interaction which covers all types of communications that could be issued by the FDA about deficiencies identified, as well as additional requests. As explained in the guidance, such requests for additional information result in placing the review clock on hold until the moment additional information will be provided. However, the approach to be applied in case of deficiencies is slightly different – the Agency expects the applicant to resolve them immediately, so the review process continues without being placed on hold. As explained in the guidance, in such cases the Interactive Review concept applies.  


Missed MDUFA Decision Communication 

The document also describes the way of actions in case the FDA fails to provide its final decision within 180 days as required under the general rule. According to the guidance, should it be the case, the Agency will contact the applicant (requester) to conduct a meeting or teleconference and discuss the reasons why the decision has not been taken. In the course of such a meeting, the parties would discuss the actions to be taken by each party, and decide on estimates for completion of the process. 

In summary, the present FDA guidance highlights the most important aspects related to actions the FDA may take about a De Novo classification request, and also the way these actions impact the review clock. The document also provides additional clarifications regarding the way the authority will interact with the applicant to facilitate the review process. 



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