FDA Clearance & Compliance
Executed to Completion.
We build defensible regulatory strategies and submission-ready documentation for MedTech, AI/SaMD, OTC drugs, and MoCRA cosmetics, so teams move faster with fewer avoidable FDA questions.
Prefer to send details first? Submit your project.
510(k) + eSTAR
Predicate alignment, claim discipline, reviewer-ready narratives.
SaMD / AI
PCCP support, cybersecurity, transparency & evidence mapping.
OTC + MoCRA
Listings, labeling readiness, claim substantiation strategy.
Remediation
CAPA, 483 / warning letter response, inspection readiness.
Operating model
Senior-Led Execution, No Junior Handoffs.
Big-firm structure with boutique speed. We organize your submission around reviewer clarity: intended use, predicate rationale, evidence alignment, and labeling discipline.
Best fit for
- Teams targeting submission in the next 30–180 days
- Products where claims, evidence, and labeling must align tightly
- Founders needing fast, defensible senior direction
Not the best fit for
- “Just fill out the paperwork” expectations without strategy
- Projects unwilling to close evidence gaps before submission
- Lowest-cost provider selection over defendability
Service areas
Regulatory workstreams built for clearance.
Choose a lane or combine them into a single submission program with clear milestones.
FDA 510(k) Submissions
Predicate search, equivalence mapping, eSTAR build, testing matrix, and FDA interaction support.
Explore 510(k) Strategy →SaMD / AI Strategy
Classification, intended use discipline, cybersecurity documentation, PCCP alignment, and evidence planning.
Explore SaMD / AI →Regulatory Advisory Programs
Pathway assessment, claim and risk positioning, evidence roadmap, and timeline/cost planning.
View Advisory Programs →483 / Warning Letter Response
Root cause analysis, CAPA, response drafting, and inspection-ready remediation execution.
Warning Letter Support →Post-Market Surveillance
Complaints, MDR, trending, CAPA linkage, and audit-ready post-market documentation.
Post-Market Support →Risk Management & QMS
ISO 14971 files, QMS buildout (QSR/ISO 13485), internal audit prep, and corrective coaching.
Risk & QMS →Process
From Concept to Clearance, Structured and Fast.
A transparent operating rhythm designed to eliminate rework and reduce avoidable FDA questions.
Strategy Call
Define product, claims, timeline, evidence, and the fastest defensible pathway.
Pathway Assessment
Classification logic, predicate landscape, evidence map, and testing matrix.
Author & Assemble
Reviewer-ready narratives, labeling alignment, eSTAR build, and quality checks.
FDA Interaction
Interactive review support, response drafting, and clearance momentum management.
Outcomes
What changes when your program is built right.
Illustrative outcomes (replace with anonymized case studies as you publish them).
Submission story unified for reviewer clarity
- Claim set refined to match available evidence
- Predicate alignment documented with equivalence mapping
- Testing matrix created to close gaps before submission
Defensible change control + cybersecurity package
- PCCP-ready documentation roadmap
- Security controls & evidence plan aligned to intended use
- Reduced back-and-forth during review cycles
Inspection-ready CAPA and response execution
- Root cause analysis structured for auditors
- CAPA linkage and effectiveness verification plan
- Documentation standardized for sustained compliance
FAQ
Straight answers, built for decision-makers.
Clear guidance on pathway, evidence, timelines, and risk.
Do you work in eSTAR for 510(k) submissions?
Yes. We build and review eSTAR submissions, including device description, performance testing, labeling alignment, and reviewer-ready narratives to reduce avoidable questions.
How do you approach predicate selection?
We start with intended use and technological characteristics, then document equivalence logic and evidence mapping. If multiple predicates are needed, we structure the comparison defensibly.
Can a product be “510(k) exempt” and still create enforcement risk?
Yes. Exemptions have limitations (e.g., intended use, fundamental technology). If a product exceeds those limits, marketing without clearance can create misbranding/adulteration risk.
Do you offer flat-fee pricing?
Yes. Most engagements are fixed-scope with clear milestones so clients know total cost upfront and avoid surprise billing.
What do you need to start?
At minimum: product overview, intended use/claims draft, current evidence/testing status, labeling or IFU drafts (if available), and your target timeline.
Next steps
Ready to build a defensible FDA pathway?
Get a clear plan, a realistic evidence roadmap, and execution that holds up to scrutiny.
Contact
For fastest routing, include product type, intended use, current evidence, and target submission date.
Headquarters
1200 N Federal Hwy, Suite 300
Boca Raton, FL 33432
Phone
(866) 779-9719
info@verusfda.com
Resources
Submit your project
We’ll reply quickly with next steps and the info needed to scope accurately.