Definition · Plain-language
De Novo classification
De Novo classification is the FDA pathway for novel low-to-moderate-risk medical devices that have no legally marketed predicate, providing a route to market that creates a new device classification.
The step most authors miss
Doing CRediT right? Don’t stop at the statement.
A CRediT statement credits you inside one paper. The recognition CRediT was built for happens when those roles are tied to you, persistently. Sign in with your ORCID — free — and claim your CRediT contributions on casrai.org, the home of the standard. They become a verified, portable part of your identity, not a line that disappears into one PDF.
Free: claim your contributions, then export a journal-ready CRediT statement, schema.org structured data, JATS XML, CSV or BibTeX — and preview your public profile. A membership publishes that profile publicly and verifies the journals you serve.
The problem De Novo solves
When a new device has no legally marketed predicate, it cannot use the 510(k) substantial-equivalence pathway. Historically such a device would be automatically classified as Class III — the high-risk category — and pushed toward Premarket Approval, even if it actually posed only low or moderate risk. The De Novo route was created to address this mismatch. It lets the FDA classify a novel low-to-moderate-risk device into Class I or Class II based on a risk-based evaluation, with general or special controls sufficient to provide reasonable assurance of safety and effectiveness.
How the process works
A sponsor submits a De Novo request asking the FDA to make a risk-based classification determination for a device of a new type. The FDA reviews the device’s characteristics, intended use and the controls needed to mitigate its risks. If granted, the device is classified — typically into Class I or II — and may be marketed. The agency establishes a new classification regulation and identifies the controls that apply, building a regulatory category where none previously existed.
Why it matters for later devices
Because a granted De Novo creates a new device type and classification, it can serve as a predicate for subsequent 510(k) submissions by other manufacturers making similar devices. In this way the pathway not only brings the first-of-its-kind device to market but also opens a 510(k) route for follow-on products. It thus complements the 510(k) and PMA pathways, filling the gap for genuinely novel devices whose risk profile does not justify the most stringent review.
Key facts
At a glance
- Definition: Pathway to classify a novel low-to-moderate-risk device with no predicate.
- Stands for: De Novo classification request.
- Problem solved: Avoids automatic Class III status for novel lower-risk devices.
- Typical result: New Class I or Class II classification with controls.
- Knock-on effect: A granted De Novo can be a predicate for later 510(k)s.
- Authority: Section 513(f)(2) of the Federal Food, Drug, and Cosmetic Act.
Common misconceptions
What people often get wrong
Often heard: De Novo is only for high-risk devices.
Actually: De Novo is specifically for novel devices of low to moderate risk that lack a predicate. High-risk Class III devices generally require Premarket Approval, not De Novo classification.
Often heard: A De Novo device can never be used as a predicate.
Actually: A granted De Novo establishes a new device type and classification, which can then serve as a predicate for future 510(k) submissions by other manufacturers.
Often heard: De Novo is just a faster version of Premarket Approval.
Actually: They are different instruments. De Novo is a risk-based classification route for novel lower-risk devices, resulting in Class I or II status, whereas PMA is the approval pathway for high-risk Class III devices.
Going deeper
