De Novo classification for devices without a predicate.
When there is no legally marketed predicate, the De Novo pathway creates one. REGARA helps you build the risk-based, special-controls case the FDA needs to grant classification.
The De Novo classification request is the FDA route for novel devices of low-to-moderate risk that have no valid predicate and would otherwise default to Class III. A granted De Novo classifies the device into Class I or II and establishes the special controls that future devices of that type can use as a predicate for their own 510(k)s.
Because there is no predicate to compare against, a De Novo lives or dies on its benefit-risk analysis and the special controls proposed to mitigate each identified risk. The documentation burden is closer to a PMA in rigor than a routine 510(k).
REGARA structures the request around the risk framework the FDA applies — drafting the classification rationale, mapping each probable harm to a proposed control, and keeping the evidence for each mitigation traceable.
- 01Benefit-risk drafting
Draft the classification summary and benefit-risk analysis against current De Novo guidance, with each conclusion anchored to its supporting data.
- 02Special-controls mapping
Map every identified probable harm to a proposed special control and the evidence that shows it is adequate — the heart of a grantable De Novo.
- 03Precedent research
Surface granted De Novos and their special controls for comparable device types to calibrate what the FDA has accepted before.
- 04Reviewer simulation
Anticipate the classification questions a lead reviewer will raise, and close the gaps before submission.
Why De Novo is a different kind of submission.
You define the type.
A De Novo doesn’t compare to an existing device — it creates a new classification. The reasoning has to stand entirely on its own.
Mitigation is the argument.
The FDA grants based on whether your proposed special controls adequately mitigate each risk. REGARA keeps that mapping explicit and evidenced.
You become the predicate.
A granted De Novo becomes the predicate for an entire device category — a strategic asset worth getting right.
- QWhat is a De Novo classification request?
A De Novo request asks the FDA to classify a novel low-to-moderate-risk device into Class I or II when no legally marketed predicate exists. Without it, such a device would automatically fall into Class III and require a PMA.
- QWhen should I use De Novo instead of a 510(k)?
Use De Novo when your device has no valid predicate to establish substantial equivalence but is not high-risk enough to warrant a PMA. If a suitable predicate exists, a 510(k) is usually the faster route.
- QWhat are special controls?
Special controls are the specific requirements — performance standards, labeling, biocompatibility, clinical data, and more — that the FDA determines are necessary to provide reasonable assurance of safety and effectiveness for a device type. They are proposed in the De Novo and reused by later 510(k)s.
- QHow does REGARA help with a De Novo?
REGARA drafts the classification and benefit-risk narrative against current guidance, maps each probable harm to a proposed special control with traceable evidence, and surfaces comparable granted De Novos so your case reflects what the FDA has accepted.
Explore related pathways and research.
Draft and defend a substantial-equivalence submission with predicate evidence built in.
PathwayAssemble a modular PMA with clinical evidence and manufacturing sections.
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Make your De Novo grantable.
Bring your novel device. We’ll draft a classification rationale and a special-controls map in a 30-minute working session.