510(k) Medical Devices
Services & pricing built for reviewer clarity.
Verus FDA helps Class II device teams move from “we think it’s a 510(k)” to a submission package that holds up under review: predicate selection + substantial equivalence, right-sized testing strategy, and consistent eSTAR build + QA.
Predicate story
Alignment on intended use, tech characteristics, and claim boundaries.
Evidence map
Standards + testing plan tied to risks and performance claims.
eSTAR build
Structure, exhibits, naming, and cross-checks for completeness.
Reviewer readiness
Consistency across narrative, tables, labeling, and V&V.
Services & pricing
Transparent bands. Defensible deliverables.
Pricing depends on device complexity, software/cyber scope, testing burden, and how much content already exists (DHF, V&V, labeling, risk). Below are common engagement bands.
Predicate Search + Pathway Memo
- Product code + regulation + classification screen
- Predicate shortlist with rationale (intended use/tech/claims)
- High-level substantial equivalence approach + key deltas
- Testing strategy outline (bench/EMC/biocomp/software/cyber as applicable)
- Recommended submission type (Traditional/Special/Abbreviated) + risk notes
Deliverable: a concise memo you can share internally (and with investors) to explain the pathway, predicates, and evidence plan.
510(k) Project — Full Build
- Traditional / Special / Abbreviated strategy + scope lock
- SE narrative + comparison tables + differences justification
- Evidence mapping + testing roadmap (and standards alignment)
- eSTAR assembly, exhibits, naming conventions, cross-checks
- Submission readiness QA to reduce avoidable RTA issues
Typical range is driven by software/cyber, number of indications/claims, testing burden, and completeness of existing DHF/V&V.
eSTAR / RTA / AI Rescue
- 48-hour eSTAR audit (structure, completeness, inconsistencies)
- RTA remediation plan + section-level fixes
- AI request response drafting support (technical + formatting)
- Evidence/labeling alignment to reviewer questions
If your 180-day clock is running, speed and internal consistency matter more than “perfect prose.”
QMSR Gap Audit
Typical: $5,000–$7,500
- DHF/design control readiness for submission + inspection
- CAPA/risk/design traceability gaps
- Prioritized remediation plan
eSTAR Build + QA (Packaging Only)
Typical: $4,500–$15,000
- Section mapping + exhibit structure
- Consistency checks across docs/tables/labeling
- Final completeness and formatting QA
Testing Strategy & Standards Roadmap
Typical: $3,500–$12,500
- Recognized standards selection + rationale
- Test plan outline + sequencing
- Traceability: requirements → risks → V&V → labeling
• Fees are for consulting services and document preparation (testing lab fees and clinical study costs are separate).
• Final pricing is confirmed after intake (intended use/claims, tech characteristics, software/cyber scope, and evidence status).
• We support full authoring, co-authoring, or a “quality layer” (packaging/QA + reviewer readiness).
Submission types
Choose the fastest route that remains defensible.
We recommend the pathway based on indications, technology, evidence plan, and eligibility rules.
Traditional 510(k)
Default route for most Class II devices with broader evidence packaging.
- Full SE narrative + comparisons
- Broader performance evidence
- Complex tech/claims support
Special 510(k)
Design-control-based modifications when eligibility is defensible.
- Eligibility rationale
- Change impact + V&V traceability
- Package built for speed
Abbreviated 510(k)
Leverages recognized standards/guidance for efficiency where appropriate.
- Conformance approach
- Standards rationale
- Efficient evidence packaging
RTA / AI Rescue
Recovery + response support to protect your timeline.
- RTA fixes + completeness
- AI drafting + evidence alignment
- Reviewer-ready clarity
Process
How we run 510(k) engagements.
A repeatable method that keeps documents consistent and timelines predictable.
Pathway + Predicate
Lock intended use/claims, confirm product code fit, and select the strongest predicate strategy.
Evidence Strategy
Standards + testing roadmap (and clinical strategy if needed), mapped to risks and performance claims.
SE Narrative + Drafting
Write/co-write key sections, build comparison tables, and maintain defensible substantial equivalence logic.
eSTAR + QA
Assemble in eSTAR, run final QA, and prepare for RTA/AI response readiness.
FAQs
Straight answers for decision-makers.
Pathway, evidence, timelines, and pricing—without fluff.
What exactly is included in the Predicate Search + Pathway Memo?
A predicate shortlist and recommendation with a clear rationale, your likely product code/regulation fit, a high-level SE approach, and a “what evidence will we likely need” testing roadmap—designed to turn ambiguity into a defendable plan.
Is the Predicate Search fee credited if we move forward?
Yes. If you retain Verus FDA for the full 510(k) project, the $3,500–$7,500 Predicate Search + Pathway Memo fee is credited toward the project fee.
Can you do eSTAR assembly even if we draft the content?
Yes. We can own the full build, co-author key sections, or act as a “submission quality layer” for packaging/QA and consistency checks.
What drives the spread in project pricing?
The biggest drivers are software/cybersecurity scope, number of indications/claims, testing burden, and how complete your DHF/V&V and labeling already are.