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A curated library of Verus FDA work across 510(k), SaMD/AI, OTC-to-insurance growth, FSA/HSA eligibility, remediation, predicate strategy, international entry, and payer alignment—built to rank in search and convert serious founders, brands, and manufacturers.
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Pathways, risks, and deliverables are explicit—no vague “consulting” claims.
Commercial Outcomes
Positioning, reimbursement, and channel unlocks that protect margins.
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De-risking narratives that support diligence, fundraising, and partnerships.
Case study series across Verus FDA services
Publish as individual pages or keep as a single “library” page. Each card can become its own URL later.
How Verus FDA Secured 510(k) Clearance for a Light-Based Acne Device in 92 Days
The Challenge
A dermatology-focused device company developed a blue-light acne treatment device but underestimated FDA submission complexity. They believed they could “add blue light” to an existing predicate without new regulatory analysis.
Regulatory Risk
- New wavelength = new technological characteristic
- Risk of FDA Additional Information (AI) hold
- Biocompatibility testing gaps
- Incomplete ISO 14971 risk management file
- Labeling inconsistencies
Verus Strategy
- Predicate matrix + technology comparison grid
- Risk assessment per ISO 14971
- IEC 60601 testing alignment
- eSTAR build-out
- Indications for Use refinement
- Clinical literature bridging strategy
Outcome
- Submission accepted without Refuse to Accept (RTA)
- No major Additional Information cycle
- Cleared in 92 days
- Enabled dermatology distribution expansion
Navigating FDA Clearance for an AI-Powered Neurological Software Platform
The Challenge
An AI-driven neurological assessment platform assumed that “software” meant lower FDA scrutiny.
Regulatory Risk
- Incorrect device classification
- Algorithm change control uncertainty
- Insufficient clinical validation
- Lack of cybersecurity documentation
Verus Strategy
- Classification triage
- Q-Sub strategy
- Algorithm transparency documentation
- Clinical performance framework
- Cybersecurity risk file
- SaMD-specific labeling
Outcome
- Defined appropriate regulatory pathway
- Avoided unnecessary De Novo
- Strengthened investor confidence
- Reduced regulatory timeline by 6–9 months
Transitioning an OTC Dermatology Brand into Insurance-Reimbursable Channels
The Challenge
An established OTC eczema brand wanted payer access but had no ICD-10 alignment, NDC strategy, or reimbursement pathway.
Regulatory & Commercial Risk
- No recognized coding pathway
- IRS 213(d) ambiguity
- Inability to access HSA/FSA channels
- Retail margin pressure
Verus Strategy
- ICD-10 disease-state mapping
- NDC drug listing strategy
- Label claims review
- Insurance positioning assessment
- 213(d) qualification framework
- Commercial access roadmap
Outcome
- Eligible for FSA/HSA programs
- Positioned for Medicaid discussions
- Improved retail leverage
- Enhanced perceived medical legitimacy
Making a Red-Light Therapy Device Eligible Under IRS 213(d)
The Challenge
A wellness device brand wanted to advertise “FSA/HSA eligible” but had no substantiation framework.
Risk
- IRS compliance exposure
- Marketing misrepresentation
- Retail rejection
- Consumer chargebacks
Verus Strategy
- IRS 213(d) analysis
- Medical purpose documentation
- Indications alignment
- Letter of Medical Necessity structure
- Marketplace compliance alignment
Outcome
- Approved for FSA/HSA platforms
- Increased conversion rates
- No price discounting required
- Expanded DTC profitability
Responding to an FDA Warning Letter in 15 Business Days
The Challenge
A manufacturer received an FDA warning letter for QMS deficiencies and improper labeling claims.
Risk
- Product seizure
- Import detention
- Retail termination
- Reputation damage
Verus Strategy
- Gap assessment
- CAPA rebuild
- Risk file remediation
- Revised labeling
- Formal FDA response drafting
Outcome
- FDA accepted response
- Avoided escalation
- Restored commercial operations
- Implemented audit-ready QMS
Avoiding a Costly De Novo Through Strategic Predicate Selection
The Challenge
A startup believed their device had no predicate.
Risk
- $200K+ unnecessary regulatory pathway
- 2–3 year delay
Verus Strategy
- Expanded technological search
- Cross-indication comparison
- Regulatory database deep dive
- Substantial equivalence matrix
Outcome
- Identified viable predicate
- Avoided De Novo
- Reduced timeline by 18+ months
Regulatory Strategy for Entering the Brazilian Medical Device Market
The Challenge
A U.S.-cleared device sought Brazil distribution without a local regulatory partner.
Risk
- ANVISA noncompliance
- Distributor misalignment
- Labeling rejection
Verus Strategy
- Classification analysis
- Brazil regulatory mapping
- Label translation compliance
- Distributor regulatory vetting
Outcome
- Market entry structured
- Reduced approval timeline
- Local compliance safeguards established
Structuring a Dermatology Device for Medicaid Recognition
The Challenge
A brand wanted access to Medicaid but lacked coding and disease-state positioning.
Verus Strategy
- ICD-10 mapping
- CPT cross-reference
- State Medicaid framework review
- Label positioning guidance
Outcome
- Reimbursement pathway clarity
- Improved payer discussions
- Increased institutional interest
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