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
Fee schedule effective October 1, 2026 (FY2027)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). Fees quoted as “from” reflect a minimum scope and are confirmed in writing after intake.
Predicate & Pathway Assessments
- Predicate & SE Landscape Memo$3,500
- — complex, multi-predicate, or novel tech (SaMD, AI)$5,500
- Predicate Verification (confirm a predicate you have)$2,500
- FDA Pathway & Readiness Diagnostic$6,500
- 513(g) Request for Information$4,500
- Pre-Submission (Q-Sub) prep + meeting support$7,500
Delivered within 5 business days. Includes review of the actual clearance letters and 510(k) summaries — not database listings.
510(k) Project — Full Build
- Special 510(k)from $12,500
- Abbreviated 510(k)from $18,500
- Traditional 510(k)from $32,500
- SaMD / AI-enabled 510(k)from $45,000
- De Novo requestfrom $65,000
- Additional model or variant on a filing$2,500
- Additional product code$5,000
Includes SE narrative and comparison tables, evidence mapping and standards alignment, eSTAR assembly with exhibits and cross-checks, and submission-readiness QA to reduce avoidable RTA issues. Small Business Determination filing is included.
Prefer to spread it out? The 510(k) Build Plan runs the same scope at $7,500/month over a six-month minimum, with predicate watch and the risk file included.
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
$9,500
- DHF/design control readiness for submission + inspection
- CAPA/risk/design traceability gaps
- Prioritized remediation plan
eSTAR Build + QA (Packaging Only)
$6,500–$18,500
- Section mapping + exhibit structure
- Consistency checks across docs/tables/labeling
- Final completeness and formatting QA
Testing Strategy & Standards Roadmap
$5,500–$12,500
- Recognized standards selection + rationale
- Test plan outline + sequencing
- Traceability: requirements → risks → V&V → labeling
ISO 14971 Risk Management File
$8,500
- Hazard analysis + risk control traceability
- Risk management plan and report
- Linked to V&V evidence and labeling
Cybersecurity Documentation Package
$12,500
- Security risk management (AAMI SW96) + threat model
- Rated cybersecurity risk assessment
- Architecture views + SBOM framework
Registration, Listing & SBD
$850–$2,750
- SBD filing — domestic (Form 3602)$1,500
- SBD filing — foreign$2,750
- Annual SBD renewal$850
- Establishment registration / renewal$1,200/yr
- Device listing (new or update)$250
- U.S. Agent designation$1,500/yr
SBD supporting information must reach FDA at least 60 days before the user fee is due.
• Fee schedule effective October 1, 2026 (FY2027). Existing clients are held at prior-year pricing through their next renewal.
• Fees are for consulting services and document preparation. FDA user fees, testing lab fees, and clinical study costs are billed at cost and 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).
• Predicate Watch monitoring is available at $500/month, and is included in the Device Growth Partner, 510(k) Build Plan, and Inspection-Ready programs.
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)
from $32,500
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)
from $12,500
Design-control-based modifications when eligibility is defensible.
- Eligibility rationale
- Change impact + V&V traceability
- Package built for speed
Abbreviated 510(k)
from $18,500
Leverages recognized standards/guidance for efficiency where appropriate.
- Conformance approach
- Standards rationale
- Efficient evidence packaging
RTA / AI Rescue
$4,500–$12,500
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 & SE Landscape 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. We read the actual clearance letters and 510(k) summaries, not just the database listing, because that is where the discrepancies live: a listing that references a clearance is not the same as holding one, and wavelengths, indications, or models present in marketing material are routinely absent from the clearance itself.
What is the difference between the Memo, the Diagnostic, and a 513(g)?
The Predicate & SE Landscape Memo ($3,500) answers which predicate and whether the equivalence argument holds. The Pathway & Readiness Diagnostic ($6,500) adds classification and product code mapping, an evidence gap analysis, a testing matrix, and timeline/budget — the whole path. A 513(g) ($4,500 plus the FDA fee) buys FDA’s own written classification answer rather than our analysis.
Is the assessment fee credited if we move forward?
Yes. One assessment fee is credited in full against a 510(k) or De Novo engagement opened within 90 days. If you purchased more than one assessment, the highest is credited.
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 at $6,500–$18,500 depending on submission size.
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. A SaMD submission carries IEC 62304 documentation, a cybersecurity package, and software V&V that a non-powered device does not, which is why the floors differ by more than $30,000.
Do you handle Small Business Determination?
Yes, and it is included at no additional charge with any 510(k) project. Standalone, it is $1,500 domestic or $2,750 where a national taxing authority certification is required. Timing matters: supporting information must reach FDA at least 60 days before the user fee is due, and qualification must be renewed each fiscal year before September 30.