Regulatory Affairs
FDA De Novo Classification Request
A market path for novel, low-to-moderate-risk devices with no predicate.
What It Is
The De Novo process creates a path to market for novel devices that are low to moderate risk but have no legally marketed predicate, so a 510(k) is not possible. A granted De Novo classifies the device into Class I or Class II, establishes special controls, and creates a new classification that future devices can use as a predicate. It is the route for genuinely new device types that are not high-risk enough to require a PMA.
When You Need It
You need De Novo when your device has no suitable predicate, when a 510(k) would be refused for lack of substantial equivalence, or when FDA has previously issued a Not Substantially Equivalent (NSE) determination. Many software-driven and first-of-kind diagnostic devices take this path.
What We Do
We assess De Novo eligibility, define the special controls your device will need to support, and build the benefit-risk and performance evidence package. A De Novo is typically a three-stage engagement: pre-De Novo strategy and gap assessment, a Pre-Submission to align with FDA on classification and testing, then the De Novo application itself in eSTAR with post-submission support through the review.
We Live It, Not Just Advise It
Novel devices need novel evidence, and that evidence comes from real benches and real cycles. Within our family we develop and manufacture devices (Boulder iQ), sterilize and validate them (Boulder Sterilization), and test them (Boulder BioLabs, Boulder Package Testing). We build the special-controls evidence package as people who have actually generated that kind of data, not just summarized someone else’s.
How AuditIQ Helps
AuditIQ helps map your evidence against the special controls a De Novo establishes, surfacing where your documentation and QMS need to be strengthened before submission.
Learn more about AuditIQ →Frequently Asked Questions
When should I use De Novo instead of a 510(k)?
Use De Novo when there is no legally marketed predicate device that is substantially equivalent to yours. If you cannot make a credible substantial-equivalence argument, a 510(k) will be found Not Substantially Equivalent, and De Novo becomes the correct low-to-moderate-risk path.
How long does a De Novo take?
FDA’s MDUFA goal is 150 review days, but De Novo programs commonly run 9 to 18 months of calendar time end to end, driven by the depth of the evidence package and the novelty of the device. A Pre-Submission is essentially mandatory in practice to align on classification and testing.
Does a granted De Novo become a predicate?
Yes. A granted De Novo creates a new device classification with special controls, and subsequent devices of that type can use it as a 510(k) predicate — which is a meaningful first-mover advantage worth factoring into your strategy.
Ready to Talk Through Your De Novo Project?
Tell us where you are in the process. We respond within one business day.
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One campus, one quality system. We manufacture, sterilize, and test medical devices in-house — so our regulatory and quality work is grounded in operations, not theory.