This article focuses on De Novo classification requests to the US FDA. The five most common FDA submission types are: Investigational Device Exemption (IDE), Premarket Notification (510(k)), Premarket Approval (PMA), De Novo requests and Humanitarian Device Exemption (HDE).
The De Novo request provides a pathway to classify novel medical devices for which there is no legally marketed Class I or Class II predicate.
Many people consider De Novo similar to China’s medical device classification determination, but in fact they differ in regulatory positioning, legal effect, value for innovation and review focus. The FDA mechanism closest to China’s classification determination is the 513(g) request.
When to submit a De Novo request: companies can submit within 30 days of a 510(k) being found “not substantially equivalent”, or submit directly after determining that there is no predicate device.
The complete submission requirements are defined in 21 CFR 860.220, with materials submitted according to the FDA’s electronic Submission Template And Resource (eSTAR). The cover of the eSTAR template found on the FDA website is shown below.
From 1 October 2025, all De Novo requests must be submitted online as eSTAR premarket submissions via the CDRH Portal.
CDRH Portal registration: https://ccp.fda.gov/prweb/PRAuth/app/registration/XF7lmLtd58qPLCTz5HEph8Lu3DAILPj7*/!STANDARD
User fees apply. From 1 October 2025 to 30 September 2026, the standard fee for a De Novo request is $173,782, and the small business fee is $43,446. There is also an annual establishment registration fee of $11,423. The FDA waives the annual establishment registration fee (excluding the initial registration fee) for some small businesses qualified under the Small Business Determination (SBD) program.
The technical screening is completed within 15 calendar days of the FDA receiving the electronic submission (De Novo eSTAR). The FDA only starts technical screening for De Novo eSTARs for which the user fee has been paid. If the eSTAR is incomplete, the FDA notifies the submitter by email, identifies the missing information and places the De Novo request on hold. If no replacement eSTAR is received within 180 days of the technical screening deficiency notice, the FDA considers the De Novo request withdrawn and closes it in the system.
The FDA makes a decision on a De Novo request within 150 review days, calculated as calendar days excluding days on hold for additional information requests.
After review, the FDA makes a final decision to grant or decline. In certain circumstances the FDA may also consider a De Novo request withdrawn. If the FDA grants a De Novo request, it means:
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The new device is authorized for marketing and must comply with the applicable regulatory controls (general controls, or general and special controls);
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A new classification regulation is created for the device type;
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Where applicable, the new device can now serve as a predicate for future 510(k) submissions of similar devices;
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The FDA publishes a notice in the Federal Register announcing the new classification regulation and controls.
For manufacturers wishing to use the device as a predicate, the De Novo decision summary is also a useful reference for the type of information needed to support substantial equivalence; it is publicly available in the De Novo database at:
5. In general, the FDA declines a De Novo request when:
(1) Regulatory controls are insufficient to provide reasonable assurance of the device’s safety and effectiveness;
(2) The data in the request are insufficient to determine whether controls can provide reasonable assurance of safety and effectiveness;
(3) The probable benefits of the device do not outweigh its probable risks;
(4) If a De Novo request is declined, the device remains in Class III and the applicant may not legally market it. The applicant should usually either submit a PMA or supplement the information and submit a new De Novo request including it.
6. The FDA considers a De Novo request withdrawn when: (1) the applicant states that it withdraws the request; (2) the applicant fails to provide a complete response to an additional information request, or the deficiencies are not resolved within 180 days of the FDA’s request.
Chinese companies taking the FDA De Novo pathway should focus on the core conditions of “no predicate device + low-to-moderate risk” and improve their success rate through precise technical justification and good process management. Key points:
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Confirm there is no predicate: search the FDA product classification database to demonstrate that there is no legally marketed substantially equivalent product – the primary prerequisite for a De Novo request.
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Risk assessment: the product must be low-to-moderate risk (Class I or II), with safety and effectiveness ensured through general controls or general and special controls. If the risk is too high (Class III), the PMA pathway should be considered directly.
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Before formally submitting a De Novo, we recommend first submitting a 513(g) request (comparable to China NMPA’s classification determination) to obtain the FDA’s preliminary view on the product’s classification.
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Use a Pre-Submission meeting: for high-risk or technically complex innovative devices, a Pre-Submission meeting can be requested 60 days before formal submission to clarify review concerns.
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Appoint a reliable US Agent: overseas manufacturers must designate a “US Agent” residing in the US, responsible for emergency contact and day-to-day communication with the FDA – the most basic access requirement.
Conclusion
This is a series of educational articles introducing regulations and standards of the FDA, NMPA, GMP, CE MDR/IVDR and MDSAP.
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