De Novo classification
De Novo is the route for a novel device where no legally marketed predicate exists. It asks FDA to classify the device into Class I or Class II on the basis that general controls, or general and special controls, provide reasonable assurance of safety and effectiveness. Without it, a device type FDA has never classified is automatically Class III by statute, and Class III means a premarket approval application.
FD&C Act 513(f)(2); 21 CFR 860 subpart D
At a glance
| When to use it | No legally marketed device exists on which to base a determination of substantial equivalence. |
|---|---|
| What it produces | A written classification order, a new classification regulation, and a device that can serve as a predicate for others. |
| Two routes | Directly, or after receiving a high-level Not Substantially Equivalent determination on a 510(k). |
| FDA fee, FY2027 | $191,020 standard. $47,755 as a qualified small business. |
| Statutory deadline | 120 days from receipt of the request. |
| MDUFA performance goal | 150 FDA Days for 70 percent of requests. FDA Days exclude time on hold. |
| Submission format | eSTAR, mandatory since 1 October 2025. |
| After it is granted | FDA publishes a final order in the Federal Register within 30 days, and the classification is codified in 21 CFR Parts 862 to 892. |
Two ways in
Route 1 — direct
Where the requester has determined there is no legally marketed device on which to base a determination of substantial equivalence, a De Novo request may be submitted without first filing a 510(k). This route was added by FDASIA in 2012.
Route 2 — after an NSE
Where a 510(k) has already been filed and FDA has returned a high-level Not Substantially Equivalent determination — no predicate, a new intended use, or different technological characteristics raising different questions — a De Novo request may follow. FDA states that where it believes a device found NSE may be eligible, the NSE letter will typically say so.
The direct route avoids the cost and the months of a 510(k) that was never going to succeed. It requires the requester to be confident that no predicate exists, which is a search that has to be done properly rather than quickly.
It opens the category for everyone
Granting a De Novo request allows the device to be marketed immediately, creates a classification regulation for devices of that type, and permits the device to serve as a predicate.
FDA publishes a final order in the Federal Register within 30 days of granting, and the device's identification, classification and applicable controls are codified in Title 21 of the Code of Federal Regulations.
The commercial consequence is worth stating plainly. A granted De Novo creates the category that competitors then enter through the 510(k) route, at a fraction of the cost. The first company through pays $191,020 and carries the evidentiary burden; the second pays $28,653 and cites the first as its predicate.
Questions people ask
How is De Novo different from a PMA?
A De Novo asks FDA to classify a device into Class I or II on the basis that general or special controls are sufficient. A PMA is the approval route for Class III devices, where those controls are not sufficient. The De Novo fee is roughly 30 percent of the PMA fee.
Can a De Novo device be used as a predicate?
Yes. The statute states that any device classified through this route shall be a predicate device for determining substantial equivalence, where the device is not itself exempt from premarket notification.
Is a De Novo eligible for Third Party Review?
No, and neither is a subsequent 510(k) citing certain De Novo devices as predicates. The statute excludes devices classified under 513(f)(2) from third party review, and FDA notes that devices requiring complex special controls initially classified through De Novo may be ineligible.
Does the small business rate apply?
Yes. A qualified small business pays $47,755 from 1 October 2026 rather than $191,020, a saving of $143,265. The determination must be granted before the request is submitted.
What if FDA declines the request?
The device remains Class III, and premarket approval is the route to market.