Risk-based pathway for first-of-kind low-to-moderate risk devices.
How we help
We craft De Novo submissions with a defensible benefit-risk profile, special controls draft, and probable-benefit clinical evidence.
Category
Medical Device Regulatory
FDA De Novo Classification
Risk-based pathway for first-of-kind low-to-moderate risk devices.
Representative work
IV Bag
Novel point-of-care reader — De Novo
Diagnostic instrumentation
Guiding catheter
Device classes & artefacts we support.
The problem
Without a predicate, the De Novo is your only fast path — and it lives or dies on benefit-risk framing.
Our solution
We craft De Novo submissions with a defensible benefit-risk profile, special controls draft, and probable-benefit clinical evidence.
Process
How we run this engagement.
Classification analysis & predicate-free strategy
Pre-Submission with benefit-risk discussion
Special controls proposal
Clinical / probable-benefit evidence
Response strategy & holistic deficiency answers
Ready to start?
Tell us about your program — we typically respond within one business day.
Book a free 30-min consult