De Novo Classification Request

Dr.-Ing. Benedikt JannySenior Usability Engineer | Managing Partner
Last updated: October 2026
Short definition

The De Novo Classification Request (German: De-Novo-Verfahren) is an FDA regulatory pathway for novel medical devices for which there is no predicate device. The manufacturer requests classification into Class I or II instead of automatic Class III. If the FDA grants it, a new classification regulation is created, with special controls for Class II.

On this page

The De Novo Classification Request (German: De-Novo-Verfahren) is a regulatory pathway of the US agency FDA for novel medical devices. The legal basis is Section 513(f)(2) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), the US federal law on food, drugs and cosmetics. With the request, a manufacturer asks the FDA to classify its device into Class I or Class II (see FDA device classification).

The background is a peculiarity of US law. Devices of a new type that the FDA has not yet classified are automatically Class III under Section 513(f)(1), regardless of their actual risk. Without the De Novo pathway, only the costly premarket approval (PMA) would remain. The US Congress created the pathway in 1997 with the Food and Drug Administration Modernization Act (FDAMA) to avoid unnecessary effort for the agency and industry. The name refers to the fact that the FDA evaluates the novel device anew from the ground up. In the statute, the procedure is called “Evaluation of Automatic Class III Designation”.

Since a statutory amendment in 2012, the request can also be submitted without a prior 510(k). The procedural rules have been set out in 21 CFR Part 860 Subpart D since the final rule of October 5, 2021 (in effect since January 3, 2022). In addition, the FDA describes in its guidance “De Novo Classification Process (Evaluation of Automatic Class III Designation)” of October 2021 how it handles the procedure. Like all FDA guidance documents, it contains nonbinding recommendations.

When the De Novo pathway applies

The pathway is intended for devices for which there is no legally marketed predicate device on which a demonstration of substantial equivalence could be based (see substantial equivalence and predicate device). At the same time, the device must meet the criteria for Class I or II: general controls alone or together with special controls must provide reasonable assurance of safety and effectiveness. In the preamble to the final rule, the FDA states that in the procedure it must find a low to moderate risk for the device.

21 CFR 860.200 names two routes into the procedure:

  • After a 510(k): The FDA has decided on a 510(k) premarket notification that the device is not substantially equivalent (NSE). According to the guidance, De Novo may be considered if this decision is based on a missing predicate device, a new intended use or different technological characteristics. If the 510(k) failed solely because of insufficient performance data, the device is generally not suitable.
  • Direct request (Direct De Novo): The manufacturer itself determines that there is no predicate device and requests classification without a prior 510(k).

The pathway is not suitable if the device type has already been classified or if PMA approvals already exist for it. In that case, reclassification is the intended route. Before the request, the FDA strongly recommends a Pre-Submission, especially for devices that it has not yet reviewed in a 510(k). It is not mandatory. In the Pre-Submission, the FDA can assess, among other things, whether the device qualifies for De Novo, which controls are likely to be needed and which evidence the request requires.

Content of a De Novo request

21 CFR 860.220 specifies what a request must contain. The requester may omit individual items only with a justification. The following components are particularly important for classifying the device:

  • Intended use: description of the disease or condition, the patient population and all labeled uses, including whether the device is prescription or over the counter (see Indications for Use).
  • Classification summary: for a direct request, the searches performed, a list of potentially similar devices and regulations, and a rationale of how the device differs from them.
  • Risks and measures: the probable health risks and, for each risk, the intended measures, that is, general controls and, for Class II, special controls.
  • Proposal for special controls: if Class II is recommended, an initial draft with a rationale of how these controls ensure safety and effectiveness.
  • Evidence: a benefit-risk assessment, results of nonclinical and clinical studies, software information and the labeling with instructions for use.

Since October 1, 2025, according to the FDA, De Novo requests must be submitted electronically using the agency's eSTAR template unless an exception applies (as of October 2026).

Review process

The FDA reviews a request in two stages:

  • Acceptance review: Within 15 days of receipt, the FDA informs the requester whether the request contains the information needed for a substantive review. If the FDA does not complete the acceptance review within this period, the request is deemed accepted. It can refuse the request, for example, if mandatory content is missing or the request covers several device types.
  • Substantive review: The FDA first checks whether a legally marketed device of the same type exists after all. If so, it declines the request. If data are missing, it requests additional information. While the response is pending, the review clock is paused.

Under 21 CFR 860.240, the FDA decides by written order within 120 days of receipt of the acceptable request. If the requester does not respond completely to a request for additional information within 180 days, the request is considered withdrawn. Before the decision, the FDA may inspect facilities, for example to review data collection or the implementation of quality management system requirements (see QMSR and design controls).

Grounds for declining under 21 CFR 860.260 include: the device does not meet the criteria for Class I or II, the labeling does not meet the requirements, the device type has already been classified, necessary studies have not been completed, or the requester substantially changes the intended use or technological characteristics without being asked after acceptance. If the request is declined, the device remains in Class III and may not be marketed. The manufacturer can then apply for a PMA or submit a new De Novo request with additional data.

Outcome: new classification and special controls

If the FDA grants the request (“granted” in FDA terms), the device may be marketed from the date of the order. At the same time, a new classification regulation is created for the device type. For Class II, the FDA specifies the special controls. Within 30 days, it publishes the order in the Federal Register, the official gazette of the US federal government. The regulation is then added to Title 21 of the Code of Federal Regulations.

Under 21 CFR 860.3, special controls are the controls needed for a Class II device type to provide reasonable assurance of safety and effectiveness. They include, for example, performance standards, performance testing, post-market surveillance, patient registries and guidelines.

The device can then serve as a predicate device for later 510(k)s. Other manufacturers of a similar device then do not need their own De Novo request. They demonstrate substantial equivalence through the 510(k) and also show that their device meets the new special controls. The FDA publishes the order and a summary of the review on its website.

Relevance to human factors

The De Novo pathway matters for usability engineering for two reasons.

First, special controls can explicitly contain human factors requirements. Numerous classification regulations in the Code of Federal Regulations prescribe human factors or usability testing. One example is the regulation for software applications for contraception, created through the De Novo pathway (21 CFR 884.5370): A human factors assessment must show that the intended users can identify, based on the instructions for use alone, whether they belong to the intended population, and that they use the application correctly. Similarly, the regulation for over-the-counter ECG software (21 CFR 870.2345) requires human factors and usability testing. It is meant to show that users use the device correctly based on the labeling alone and interpret the output correctly. Because the requester itself helps propose the special controls, it influences the requirements that will later also apply to devices of the same type.

Second, the FDA guidance “Content of Human Factors Information in Medical Device Marketing Submissions” (final version of May 29, 2026) expressly names De Novo requests as a type of submission to which it applies. It derives the scope of human factors information for a new device from the use-related risk analysis (URRA). Tasks whose incorrect or omitted performance can cause serious harm are decisive. IEC 62366-1 considers such cases in hazard-related use scenarios, while the FDA speaks of critical tasks.

  • If the URRA yields no critical tasks, the submission falls into HF Submission Category 2.
  • If there are critical tasks, the question of whether data from a human factors validation are needed decides between Category 2 and 3.
  • Category 3 comprises an HFE/UE report with the results of the validation.

As a circumstance in which validation data may be needed, the guidance names a clear difference from similar marketed devices, for example a novel technological feature, a new indication or new user groups. For De Novo devices, for which by definition there is no predicate device, this point needs particularly careful review. Whether human factors data and which special controls are likely to be required can be clarified in the Pre-Submission before studies begin.

In brief

The De Novo Classification Request is the FDA pathway for novel medical devices without a predicate device whose risk can be controlled with general and, where applicable, special controls. Instead of automatic Class III, the device is classified into Class I or II.

Granting the request creates a new classification regulation, with special controls for Class II. These can prescribe human factors testing, and the device will serve as a predicate device for later 510(k)s.

Frequently asked questions (FAQ)

When do you choose the De Novo pathway instead of a 510(k)?

When there is no legally marketed predicate device on which substantial equivalence could be based, and the device still meets the criteria for Class I or II. The request can be submitted after a declined 510(k) or directly.

How does the De Novo pathway differ from a PMA?

The PMA is the approval pathway for Class III devices. The De Novo pathway, by contrast, leads to classification into Class I or II. It requires that general controls alone or together with special controls provide reasonable assurance of safety and effectiveness.

Is a Pre-Submission required before the De Novo request?

No. The FDA strongly recommends it, though, especially for devices that it has not yet reviewed in a 510(k). In the Pre-Submission, the FDA can assess whether the device is suitable and which controls and evidence are likely to be needed.

Does a De Novo request need human factors data?

That depends on the device. According to the FDA guidance on human factors information in submissions, the scope follows from the use-related risk analysis and the critical tasks. If there are critical tasks and a validation is needed, an HFE/UE report with validation data belongs in the submission.

What happens if the FDA declines the request?

The device remains in Class III and may not be marketed. The manufacturer can apply for a PMA, or collect additional data and submit a new De Novo request.

Are you preparing a De Novo request for a novel medical device and need robust human factors evidence for the FDA?

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