FDA De Novo Classification Request Guide: When to Use It and What to Submit

The De Novo pathway is how FDA classifies new, low-to-moderate-risk devices that have no suitable predicate. A granted De Novo creates a new device type, writes the special controls for it and gives later devices a predicate for 510(k). This guide explains when to use De Novo, the two routes into it, what a request contains, current submission rules and how to avoid common delays.

When De Novo is the right pathway

Under section 513(f)(2) of the FD&C Act, a device that is not substantially equivalent to a legally marketed device is automatically class III. De Novo lets the sponsor ask FDA to classify the device into class I or class II instead, when general controls, or general and special controls, provide reasonable assurance of safety and effectiveness. It suits novel devices of low to moderate risk. If a valid predicate exists, a 510(k) is usually faster. If risk is high and controls cannot mitigate it, PMA is the route. For the full pathway comparison, see US FDA medical device regulations.

Two ways in

• Direct De Novo: you submit a De Novo request without first filing a 510(k), because you believe there is no predicate.
• De Novo after a 510(k): you file a 510(k), receive a not substantially equivalent (NSE) decision, and then submit a De Novo request.

A Pre-Submission meeting before a direct De Novo helps confirm the route, the evidence plan and the proposed special controls.

What a De Novo request contains

• Administrative information and device description, including principles of operation and any software.
• Indications for use and a classification recommendation, with the reasoning.
• Risk analysis: identified risks to health, how each is mitigated and the benefit-risk case. See ISO 14971 risk management.
• Proposed special controls and how the evidence shows they are enough.
• Performance data: bench, biocompatibility, software, electrical safety, human factors and clinical data as the device requires.
• Labelling. See medical device labeling requirements.
• Summary of the search for predicates, where relevant, and an explanation of why existing devices are not suitable.

Submission rules to know in 2026

• eSTAR is mandatory. Since October 1, 2025, De Novo requests must be submitted electronically with eSTAR, unless an exemption applies.
• User fees. A De Novo request carries a user fee that is reset every October 1, with a reduced fee for qualified small businesses holding a Small Business Determination. For FY2026 the published standard fee was about $173,782 and the small business fee about $43,446. Always check the current MDUFA fee schedule.
• Review goal. Under MDUFA V, FDA’s goal is a decision within 150 FDA days for most requests. Actual elapsed time depends on questions asked and your response time.
• MDUFA VI. A draft commitment letter for fiscal years 2028 to 2032 was discussed at an FDA public meeting in August 2026 and proposes changes to De Novo interactions. Treat it as proposed until finalised.

After a grant

FDA issues a decision letter and later publishes a classification order that sets the device type, its class and its special controls. Future devices of this type can use yours as a predicate, and most will need to meet the special controls in the order. Keep your own documentation current, because your design and post-market obligations continue under the QMSR.

Common mistakes

• Choosing De Novo when a reasonable predicate exists, or 510(k) when none does.
• Proposing special controls that are vague or not tied to the identified risks.
• Thin risk analysis that does not link each risk to testing.
• Weak or missing human factors and software documentation. See usability engineering.
• Ignoring the eSTAR structure, which leads to avoidable delays.

Frequently asked questions

How long does a De Novo take?

The MDUFA goal is 150 FDA days for most requests, but total time depends on FDA questions, your response time and the complexity of the device. Plan for more time than the goal.

Can I get Breakthrough designation for a De Novo device?

Yes. Breakthrough Devices can be reviewed through PMA, 510(k) or De Novo. Designation may also matter for Medicare coverage. See US medical device reimbursement.

What is the difference between De Novo and 510(k)?

510(k) compares your device to a predicate. De Novo creates a new classification when no predicate exists.

Does a granted De Novo give market protection?

No. Later devices can use yours as a predicate once the classification order is published, which can open the market to competitors.

Talk to the AptSkill team

Need training on FDA submission strategy for your regulatory team? Send us a message.