Novel Devices, Strong Evidence Plans — Without Strategic Missteps
We help innovators pursue Breakthrough Device designation and/or De Novo classification with a disciplined approach: eligibility framing, Q-Sub strategy, evidence roadmaps, and submission builds that translate innovation into a reviewable package.
Why Advanced Pathways Need More Than “Good Science”
For novel devices, the failure mode is rarely “the idea.” It’s the framing: indications that are too broad, unclear benefit/risk, underpowered evidence plans, missing special controls, or a submission that doesn’t read like a controlled system. We help you translate innovation into structured claims, defensible endpoints, and review-ready documentation.
- Eligibility & scope: Breakthrough and De Novo hinge on precise indications and meaningful benefit framing.
- Evidence planning: clinical, bench, software, usability, and real-world evidence must be coordinated and justified.
- Special controls: De Novo success depends on proposing realistic controls and showing you can meet them.
- Regulatory storytelling: the dossier must connect benefit → risks → controls → verification in a single narrative.
Breakthrough & De Novo Programs
Programs designed for novel devices where strategy and evidence design matter as much as the paperwork.
Advanced Pathway Strategy Sprint
Typical range: $3,500–$9,500
For teams deciding: Breakthrough? De Novo? 510(k)? and what evidence is realistically required.
- Regulatory pathway triage + indication scoping
- Benefit/risk framing and “why existing options are inadequate” narrative
- Evidence roadmap: bench/clinical/usability/software/cyber as applicable
Breakthrough Designation Package
Typical range: $6,000–$15,000
For eligible devices that can demonstrate meaningful advantage for serious conditions.
- Eligibility analysis + designation strategy
- Drafting the request (clinical context, alternatives, benefits, evidence summary)
- Submission packaging + response support if FDA asks follow-ups
De Novo Evidence & Special Controls Plan
Typical range: $7,500–$22,000
For novel devices that need a structured plan that anticipates special controls and review expectations.
- Draft special controls concept (testing, labeling, clinical, post-market as needed)
- Risk management alignment: hazards → controls → verification
- Study and testing strategy (endpoints, usability, human factors, software/cyber)
De Novo Submission Full Build
Typical range: $25,000–$85,000+
For complete De Novo submissions built to read like a controlled system, not a loose collection of documents.
- Full drafting and assembly: device description, risks/mitigations, performance, labeling
- Coordination support for testing vendors + report review + gap closure
- Deficiency response support (structured, evidence-driven, consistent)
Who We Help
First-in-Class Devices
Novel technology where there is no clean predicate and the “special controls” conversation must be shaped carefully.
Software-First & AI/ML Devices
Teams needing rigorous evidence planning, clinical validation framing, and software/cyber documentation that’s reviewable.
Serious Condition / Unmet Need
Devices that may qualify for Breakthrough and need the “meaningful benefit” case written with discipline.
Clinical Strategy Tightening
Projects with data but unclear endpoints, comparators, or claims—where small wording changes shift the whole pathway.
Investor-Driven Roadmaps
Teams that need a credible FDA timeline and evidence plan that withstands diligence and avoids fantasy assumptions.
Stalled or Conflicted Pathways
Products that tried 510(k) and got stuck, or that need a fresh De Novo strategy to move forward.
How We Run Advanced Pathway Engagements
Tight framing, evidence discipline, and documentation control from day one.
Indications + Benefit
We lock indications, target population, and meaningful benefit framing—so eligibility and evidence requirements stay stable.
Evidence Roadmap
We design an evidence plan spanning bench, usability/human factors, software/cyber, and clinical/RWE where appropriate.
Special Controls + Risk
We map hazards to controls and propose special controls that are realistic—and provable with planned verification.
Build + Defend
We assemble the submission and manage deficiency responses with consistency and evidence, without creating new issues.
Breakthrough & De Novo FAQs
Does Breakthrough mean “automatic approval”?
No. Breakthrough designation can provide enhanced interaction and prioritized processes, but you still need a complete evidence package. We use it to improve alignment and reduce strategic drift—not to skip requirements.
When is De Novo the right move?
When there isn’t a suitable predicate and your device can be reasonably assured safe and effective under a defined set of controls. We help you scope indications and propose special controls you can actually meet.
Do we need a Q-Sub before De Novo?
It’s not always mandatory, but it’s often strategically smart for novel devices. We’ll recommend it when it materially reduces risk or helps lock your evidence plan.
Are these pricing ranges fixed?
No—these are typical working bands. After a short triage call we can provide a fixed or milestone quote based on novelty, clinical scope, software/cyber requirements, and current documentation maturity.
Talk Through Your Breakthrough / De Novo Strategy
Share your device, target condition, current data (bench/clinical), and your intended claims. We’ll outline a sequenced plan (frame → evidence → controls → submit) with clear deliverables and a quote aligned to your timelines.
Based in Charleston, SC • Supporting device innovators worldwide
Prefer direct email? info@verusfda.com