August 5, 2026

Written by Austin Tyner

Clinical Review by Neel Parmar

What is a De Novo Classification Request? 

A De Novo request is a marketing pathway to classify novel medical devices for which general controls alone, or general and special controls, provide reasonable assurance of safety and effectiveness for the intended use, but for which there is no legally marketed predicate device. In other words, it is the FDA’s risk-based product assessment mechanism to evaluate whether a novel device can be safely regulated under the same controls that apply to established Class I and II products.

The De Novo pathway is established under section 513(f)(2) of the FD&C Act. FDA's implementing regulations are codified in 21 CFR Part 860, Subpart D. This provides a route for certain new types of devices to obtain marketing authorization as class I or class II devices. 

How does a De Novo Request differ from 510(k) and PMA pathways? 

The 510(k), PMA, and De Novo applications all serve as possible paths to market, but distinguish themselves based on the predicate device status and the determined class of the product pending risk assessment.

  • A 510(k) submission must demonstrate that the subject device has the same intended use as a legally marketed predicate and either has the same technological characteristics or has different technological characteristics that do not raise different questions of safety and effectiveness and are supported by appropriate performance data. It applies, with some exceptions, to Class II (moderate-risk) medical devices and nonexempt Class I devices. 
  • PMA (Premarket Approval) is the most stringent pathway, reserved for Class III device applicants. The products have no predicate and are higher risk and applicant devices are typically life-sustaining, life-supporting, or present a significant risk of illness or injury. PMA requirements include demonstrating safety and effectiveness independently through scientific review, typically supported by robust clinical data. They do not require a predicate Device to be identified within the application. 
  • De Novo applications are designed specifically for devices without a predicate and also without risk that would justify the Class III/PMA pathway. They do not require a substantial equivalence demonstration. The manufacturer must provide sufficient evidence to the FDA that general and special controls, or general and special controls, are enough to provide reasonable assurance of safety and effectiveness on their own. 

It can be useful to think about these pathways in terms of what the FDA is really asking the applicant to demonstrate. While a 510(k) must demonstrate substantial equivalence and a PMA must demonstrate high-risk device safety and effectiveness, the De Novo must strike a middle ground as a device without a predicate that must demonstrate low enough risk for general and special controls to be sufficient to address safety and effectiveness. 

How a Manufacturer Determines Which Path Applies 

There are two options for pursuing a De Novo request: 

  1. Not Substantially Equivalent (NSE) determination.  

    The manufacturer first submits a 510(k) in expectation of an SE finding. If the FDA comes back with a Not Substantially Equivalent (NSE) determination due to failure to establish a predicate device, a new intended use, or differing design or characteristics that raise questions of safety and effectiveness, the manufacturer can then pursue a De Novo request. 

  2. Direct submission.  

    The manufacturer, at the outset, determines that there is no legally marketed device to support an SE argument and files a De Novo request. 

The decision about which pathway is appropriate can be made by searching for a predicate device, followed by product risk assessment. The applicant should first look for anything on the market with a similar intended use and design profile. If nothing fitting the above criteria exists, De Novo becomes the logical route, provided that the device's risk profile is one that general or special controls can reasonably manage. 

Because risk judgment is important to application strategy, the FDA recommends that sponsors consider submitting a Pre-Submission to obtain feedback from the appropriate premarket review division before filing. Engaging in early dialogue with the FDA can confirm whether De Novo is the appropriate pathway before a company invests in a full submission. This can save significant time and expense if the FDA disagrees with the applicant's categorization of device risk. 

The FDA Submission Review Process  

Content and submission  

A De Novo request must include the elements defined under 21 CFR 860.220. Required content includes administrative information, detailed device description, recommended classification with supporting rationale, discussion of why general or special controls provide reasonable assurance of safety and effectiveness, relevant performance data, and a benefit-risk analysis. This is then submitted through eSTAR. 

Acceptance review 

Once the FDA receives a request, it conducts an administrative acceptance review to assess completeness and whether the submission meets the minimum threshold of acceptability. That technical screening is expected to occur within 15 calendar days of receipt and will begin only after the appropriate user fee has been paid. If the eSTAR submission is incomplete, the FDA notifies the submitter of the deficiencies and places the request on hold. A corrected submission must be received by the FDA within 180 days, or the request is considered withdrawn.  

Substantive review  

Reviewers conduct a classification analysis of legally marketed device types to confirm that no comparable device already exists and confirm the device’s De Novo eligibility, and then evaluate the safety and effectiveness data of the application. Minor issues are often resolved through informal interactive review. More significant concerns trigger a formal Additional Information letter, which places the request on hold. The requester then has 180 calendar days to submit a complete response, with no extensions granted. 

Outcome  

    1. Grant  

      The FDA grants the request and establishes a new classification regulation for the device type. The FDA voluntarily generates and publicly discloses a decision summary. The device may then be marketed, and it becomes available as a predicate for future 510(k) submissions. 

    2. Decline  

      The FDA declines the request if the controls are insufficient to assure safety and effectiveness, the data are inadequate to make that determination, or the probable benefits don’t outweigh the probable risks. The applicant can then either use the PMA pathway or refile a strengthened De Novo request. 

    3. Withdrawal  

      The FDA considers the application withdrawn if the requester formally withdraws it, fails to respond to a deficiency letter or Additional Information request in a timely manner, or denies FDA access for a facility inspection. 

How Accorto Can Help 

The Accorto medical device team can help at every stage of the De Novo process. Our experienced regulatory staff can help manufacturers determine whether the De Novo pathway is the right fit for their device, guide them through Pre-Submission planning, complete eSTAR submission, and manage FDA interactions to keep the review on track and avoid costly deficiencies or delays. 

Sources 

The United States Food and Drug Administration. De Novo Classification Request | FDA. https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/de-novo-classification-request  

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Austin Tyner

Document Specialist

Austin Tyner is Accorto’s document specialist, supporting the quality and publishing team with document onboarding, formatting, and FDA submission readiness. She holds a BA in English and Comparative Literature, with a minor in Public Policy, from the University of North Carolina at Chapel Hill.

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Neel Parmar

Regulatory Specialist I

A member of Accorto’s Regulatory Writing Team, Neel Parmar, recently graduated from Northeastern University with a Master of Science in Regulatory Affairs. His academic foundation was enriched by specialized coursework in regulatory compliance, strategic product lifecycle management, and advanced regulatory writing, preparing him to excel in complex regulatory documentation environments. Before his role at Accorto, Neel cultivated valuable experience as part of the team at Interscope Inc., contributing to the transition of a Class IIA medical device from MDD to MDR compliance. His role involved supporting the creation of critical regulatory documents and participating in comprehensive gap analyses to ensure alignment with MDR requirements.