United States · Food and Drug Administration · Medical devices
Review target
150 days
performance goal
Legal time limit
120 days
law
Steps
4
2 requirements
Application fee
$191,020
FY2027
A route for a new type of device with no predicate, where general controls, or general and special controls, can give reasonable assurance of safety and effectiveness. If granted, the device is classified into Class I or II. A novel device where general controls, or general and special controls, can give reasonable assurance of safety and effectiveness.
The official review target is 150 days (performance goal, met in 70% of cases). The legal time limit is 120 days. Time the applicant takes to answer questions (clock stops) is not counted. Targets are not actual review times.
The de novo classification request fee is $191,020 for FY2027. A reduced fee of $47,755 applies in some cases (Reduced fee for qualifying small businesses).
1. Send the De Novo request in eSTAR; 2. Review (150 days); 3. Questions to the maker (clock stopped); 4. Grant or decline.
Outcome: A grant order that creates a new classification regulation, or a decline.
Legal basis: Section 513(f)(2) of the Federal Food, Drug, and Cosmetic Act; 21 CFR Part 860 Subpart D
Each box is one step; arrows show the order. Dashed boxes happen only in some cases; the orange arrows go back (for example after questions).
About 150 days end to end with the official step targets. Targets, not actual times.
From the official approvals data of this market, all products of this pathway type and segment
In order, with the official target for each step
What the applicant must provide or meet
Targets, not actual review times
| Legal time limitlaw. The law says the request is classified within 120 days. | 120 days |
| Review targetperformance goal, met in 70% of cases. 150 review days for 70 percent of requests. This is an official target, not an actual review time. | 150 days |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| De Novo classification request feeApplication · FY2027 · Reduced fee for qualifying small businesses. | $191,020reduced $47,755 |
Other routes in United States: Premarket notification (510(k)), Premarket approval (PMA), Humanitarian device exemption, Class I devices exempt from premarket notification, Software as a medical device: how it is regulated, Breakthrough devices program, Emergency use authorization. See all routes on the United States page or explore them in the Regulatory section.
Not legal or regulatory advice. Check the current official rules before you act. This summary was checked against the official laws, regulations and regulator guidance on October 3, 2026 (8 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.