Pricing
Choose a fixed price when the deliverable is clear, or hourly support when the work is ongoing or still taking shape. Most clients use both: a fixed-price Pre-Sub or 510(k), with hourly engineering alongside.
Fixed-price packages
A defined scope, deliverables and timeline agreed before we start. Final price depends on device complexity and is confirmed in a written proposal.
Regulatory Strategy & Pathway Report
From $5,000
Typically 2–3 weeks
Device classification, product code, predicate search and a written FDA pathway recommendation.
- Classification & product code analysis
- Predicate device search
- Pathway recommendation
- Applicable standards list
- Testing & submission roadmap
FDA Pre-Submission (Q-Sub) Package
From $8,000
Typically 4–6 weeks
A complete Pre-Sub package with targeted questions for FDA, plus meeting preparation and attendance.
- Device description & proposed testing
- FDA question set
- eSTAR/PreSTAR package
- Meeting preparation and attendance
- Meeting minutes
510(k) Submission
From $20,000
Typically 8–16 weeks
Preparation and management of your 510(k) in eSTAR, including responses to FDA questions.
- Substantial equivalence comparison
- eSTAR compilation
- Testing summaries
- Labeling review
- Additional Information (AI) response support
De Novo Submission
From $60,000
Typically 12–24 weeks
Benefit-risk analysis, special controls proposal and De Novo request for novel low-to-moderate risk devices.
- Classification rationale
- Benefit-risk analysis
- Proposed special controls
- eSTAR De Novo package
- FDA interaction support
QMS Starter (ISO 13485 / QMSR)
From $15,000
Typically 6–10 weeks
A right-sized quality system for startups, ready for FDA QMSR inspections.
- Quality manual & core SOPs
- Design control procedures
- Risk management procedure
- Supplier controls
- Training & internal audit
V&V Test Protocol Pack
From $10,000
Typically 3–6 weeks
Verification and validation plans, protocols and report templates traced to your design inputs.
- V&V master plan
- Test protocols with acceptance criteria
- Sample size rationale
- Traceability matrix
- Test report templates
U.S. Market Entry for International Companies
From $1,500/yr
Typically ongoing
U.S. Agent service, establishment registration, device listing and small business fee qualification.
- U.S. Agent designation
- Registration & listing
- Small Business Determination support
- Importer guidance
Hourly support
For ongoing engineering, quality and regulatory work. You see who works on your project and pay only for the time used, billed monthly.
- Monthly retainer: 10% off hourly rates with a commitment of 40 hours or more per month.
- Minimum: 5 hours per engagement.
| Role | Rate |
|---|---|
Principal consultant Regulatory strategy, FDA meetings, submission review and sign-off. | $325/hr |
Senior engineer or regulatory specialist Design and development, risk management, V&V planning, submission writing. | $250/hr |
Engineer or quality specialist Test execution support, design documentation, QMS procedures, traceability. | $175/hr |
Documentation and project support Document formatting, eSTAR compilation, records and project coordination. | $110/hr |
What isn't included
- FDA user fees, paid directly to FDA. A 510(k) costs $28,653 in fiscal year 2027, or $7,163 for a qualifying small business. Estimate your fees
- Third-party lab testing, such as IEC 60601 safety, EMC and ISO 10993 biocompatibility. We plan and manage it, and the lab bills you directly.
- Clinical studies, if FDA requires them for your device.
Common questions
How long does a 510(k) take?
FDA's review goal is 90 FDA days, but the clock stops while you answer questions. Plan on roughly 4 to 6 months from submission to decision, plus the time to prepare testing and documentation.
What does FDA charge?
For fiscal year 2027 the standard 510(k) fee is $28,653, or $7,163 for a qualifying small business. Every establishment also pays an annual registration fee of $13,785. Estimate your fees
Can companies outside the U.S. get small business fees?
Yes. If your revenue, including affiliates, is $100M or less, you can qualify using a certification from your national tax authority. Request it before the fee is due and renew it every fiscal year.
Do we need a Pre-Submission?
It isn't required, but it's the cheapest way to avoid testing the wrong thing. We recommend one for novel devices, De Novo requests, AI-enabled devices and any uncertain test strategy. FDA aims to send written feedback within 70 days.
Do you work hourly or at a fixed price?
Both. Clearly scoped deliverables such as a Pre-Sub package or a 510(k) have fixed prices. Ongoing engineering, quality or regulatory support is billed hourly. See packages
Can you act as our U.S. Agent?
Yes. Every foreign establishment needs a U.S. Agent for FDA. It's part of our U.S. market entry package, together with registration and device listing.
Not sure what you need?
A free 30-minute call is enough for us to recommend a package or an estimate.