What is the FDA De Novo pathway?
De Novo is a classification pathway for novel devices of low to moderate risk when there is no legally marketed predicate suitable for a 510(k).
Free FDA De Novo search · No signup
FDA De Novo Database Search
Find granted De Novo classification requests for novel low- to moderate-risk devices, including the new classification name, product code, device class, requester, and decision date.
Direct FDA source dataFree, no account requiredOfficial record links
Novel device decisions
Find devices that established a new Class I or Class II classification through De Novo.
New predicate direction
See the product code and classification created by a granted request for future devices.
Decision-document links
Open the official FDA record to review the classification order and decision summary.
Search FDA De Novo decisions
Find a De Novo by device name, requester, DEN number, or FDA product code.
Try:
DJ Fang
MedTech Regulatory Expert
Need help confirming a classification or planning your registration?
Important interpretation note
A prior De Novo decision does not establish the pathway for a different device. Confirm intended use, technology, risks, special controls, and current FDA requirements.
How De Novo decisions affect pathway research
A granted De Novo creates a new device classification and product code for a novel low- to moderate-risk device that lacked a suitable predicate.
After classification, later devices may be able to use the De Novo device as a predicate in a 510(k), but substantial equivalence still depends on intended use and technological characteristics.
Read the classification order, special controls, decision summary, and regulation rather than relying only on the device name or product code.
Frequently asked questions
What does a granted De Novo create?
FDA classifies the device into Class I or II, creates a new classification regulation and product code, and identifies applicable controls.
Can a De Novo device become a 510(k) predicate?
Yes, a legally marketed device classified through De Novo can potentially serve as a predicate for a later device when substantial equivalence can be demonstrated.
Where do these records come from?
FDA includes De Novo records with DEN-prefixed submission numbers in its releasable premarket dataset. This tool restricts searches to those records and links to the FDA De Novo detail page.