Regulatory
De Novo Classification Request(De Novo)
In one line
Pathway to classify novel low- to moderate-risk devices that lack a predicate.
Definition
The De Novo classification process provides a marketing pathway to classify novel medical devices for which general controls alone, or general and special controls, provide a reasonable assurance of safety and effectiveness for the intended use, but for which there is no legally marketed predicate device.
A granted De Novo creates a new classification regulation and product code, so the device can then serve as a predicate for future 510(k) submissions. Requirements are set out in 21 CFR Part 860, Subpart D.
Why it matters
Granting a De Novo creates a new device classification (Class I or Class II with special controls) and can serve as a predicate for future 510(k) submissions, shaping the regulatory framework for an entire device category. It is intended for novel devices where risk is low to moderate but no legally marketed predicate exists.
Common pitfalls
- •Filing a De Novo when a plausible predicate exists. FDA may redirect the submission to a 510(k), losing months.
- •Underestimating the special controls FDA may impose, which become binding on the applicant and future 510(k) followers.
- •Skipping a Pre-Submission (Q-Sub) meeting to confirm De Novo is the correct pathway.
Sources