De Novo / Novel Devices
Make the pathway defensible before you spend on trials.
When a credible 510(k) predicate route isn’t viable, De Novo may be the right path—if you build it the right way. We help teams define the risk classification narrative, anticipate special controls, right-size clinical & performance evidence, and use Pre-Sub (Q-Sub) to de-risk FDA expectations before committing major time and capital.
Pathway clarity
Confirm “no viable predicate” before you commit resources.
Controls first
Special controls designed to be testable and measurable.
Evidence discipline
Right-sized bench/clinical plan aligned to claims.
FDA alignment
Pre-Sub to lock expectations and prevent late surprises.
Fit
When De Novo is the right call
De Novo is generally appropriate when your device is low-to-moderate risk and there is no legally marketed predicate to establish substantial equivalence. The win condition is a clear controls framework and an evidence story that supports safety and effectiveness.
Good fit indicators
- No viable predicate route for indications/technology
- Risk profile manageable with controls + testing
- Clear benefit story + measurable performance endpoints
- Clinical evidence is feasible (or avoidable with strong bench/performance)
Common red flags
- High-risk profile trending toward PMA expectations
- Vague intended use or unclear outcomes/endpoints
- Evidence plan relies on marketing claims vs performance measures
- Uncontrolled software/AI change and explainability gaps
Our first move
- Confirm no credible 510(k) pathway is available
- Draft the risk + controls narrative
- Map what FDA will likely ask for (and how to answer it)
Risk control
Why novel pathways fail—and how we prevent it
De Novo is won or lost on clarity: the intended use, the risk profile, the proposed controls, and whether evidence supports the claims. We force alignment early so you don’t discover late-stage that FDA expects different endpoints, different controls, or a different study.
Typical failure modes
- Unclear use case: indications and claims aren’t stable enough to design evidence.
- Controls not credible: “special controls” are vague or not testable.
- Evidence mismatch: endpoints, population, and performance claims don’t line up.
- Late FDA surprises: no Pre-Sub means you learn expectations the hard way.
Our prevention system
- Feasibility memo: pathway rationale + what De Novo must prove.
- Controls architecture: testable controls mapped to risks and claims.
- Evidence discipline: bench/clinical plan matched to endpoints and labeling.
- Pre-Sub alignment: FDA feedback to lock expectations before major spend.
Programs
De Novo & novel device programs
Pick the engagement level that matches your stage. Most teams start with feasibility + Pre-Sub planning.
De Novo feasibility + pathway memo
Typical range: $5,000–$15,000
Confirm viability and avoid months chasing the wrong pathway.
- “No viable predicate” rationale (why 510(k) won’t hold)
- Risk classification framing + controls mindset
- Special controls map + evidence plan (bench/clinical/software)
- Go/no-go recommendations + timeline assumptions
Pre-Sub (Q-Sub) for novel devices
Typical range: $8,000–$25,000+
Lock endpoints, testing scope, and controls before you spend heavily.
- Question strategy + meeting objectives
- Briefing package drafting + exhibits
- Clinical/performance testing plan framing
- Meeting prep + minutes support
Special controls + evidence architecture
Typical range: $10,000–$35,000+
Build the “spine” of the De Novo: controls, risk management, performance claims, traceability.
- Proposed special controls framework (testable + measurable)
- Risk management aligned to controls and verification evidence
- Requirements → hazards → mitigations → V&V traceability
- Labeling strategy aligned to controls and evidence
De Novo submission build support (scoped)
Typical range: $25,000–$85,000+
Drafting + packaging with document control and deficiency-response readiness.
- Core narrative drafting and exhibit planning
- Clinical/performance evidence integration
- Reviewer-readability QA + consistency checks
- Deficiency response planning + response drafting support
Note: Final scope depends heavily on clinical requirements and novelty.
Novel software / AI considerations
If your novel device includes software, AI/ML, connectivity, or cybersecurity risk, we incorporate the right artifacts into the strategy: software lifecycle expectations, change control, threat modeling, and performance validation framing.
Start async (preferred for scoping)
Share your intended use, target users, key claims, device description, and any prototype test data. We’ll respond with a scoped plan and the quickest path to FDA alignment (often via Pre-Sub).
Process
A de-risking workflow that prioritizes alignment before spend.
We stabilize the story, frame controls, align FDA expectations, then build the submission with rigor.
Intended use + claims
Stabilize the indications/claims and define measurable outcomes/endpoints.
Risk + controls
Build the risk classification narrative and a testable special controls framework.
Pre-Sub strategy
Use Q-Sub to confirm evidence expectations (bench, clinical, software/cyber) and avoid surprises.
Submission + defend
Draft and package the submission with document control and deficiency-response readiness.
FAQs
What founders and teams ask most.
Straight answers so you can make the next decision with confidence.
Is De Novo “better” than 510(k)?
It’s different. De Novo can be appropriate when there’s no credible predicate, but it often requires more planning and sometimes more evidence. We treat it as a pathway that must be justified—not a default choice.
Do we always need a clinical study for De Novo?
Not always. Some De Novo devices can be supported with strong performance/bench evidence, depending on the risk profile and claims. We screen clinical need early and use Pre-Sub to confirm expectations when uncertainty is high.
What do you need to start?
Intended use/claims, target users, device description/configurations, risk considerations, and any prototype or pilot performance data. If you have a draft study idea, we can refine endpoints and design to align with the regulatory story.