FDA SaMD cost calculator
A Class I exempt SaMD with a lightweight quality system costs $90,000–$160,000. A Class II device going through 510(k) with clinical validation and Section 524B cybersecurity documentation costs $200,000–$450,000, and complex or novel devices reach $700,000.
- 6 separately priced features
- Compliance costed as line items
- Itemised, not a single guess
- ±15–20% confidence range
At a glance
Baselines before features, compliance and multipliers.
- Class I$90K
- Class II 510(k)$200K
- Complex$450K
A typical configuration lands near $334,000 over 24–35 weeks.
Configure your fda samd
Work through the steps below — scope, features, compliance and integrations — and you get an itemised estimate with a range, a midpoint and a delivery window.
What each scope tier includes
Every calculator starts from one of three baselines. This is what separates them.
| Scope | Baseline | Typical shape |
|---|---|---|
| Class I | $90K | Narrowest useful release — one workflow, one user type, launched fast. |
| Class II 510(k) | $200K | The common case: multiple roles, reporting, and the integrations most buyers expect. |
| Complex | $450K | Multi-site or enterprise scope, deeper interoperability and heavier non-functional requirements. |
Baselines are before feature adders, compliance programmes, integrations and the platform, design and team-location multipliers. The headline range for this calculator is $90K–$540K. See how the numbers are built.
Frequently asked questions
How much does FDA clearance for SaMD cost?
A Class I exempt product with a compliant lifecycle costs $90,000–$160,000. A Class II 510(k) device costs $200,000–$450,000 including about $40,000 in submission support and $35,000 in clinical validation. Complex or De Novo pathways run $450,000–$700,000 and up.
What are the FDA fees themselves?
FY2026 510(k) user fees are roughly $24,000 standard and about $6,000 for a qualified small business, on top of the engineering and consulting costs above. De Novo requests cost roughly $145,000 standard. Annual establishment registration is about $9,000. These fees sit outside the estimate produced here.
When does software become a regulated medical device?
When it diagnoses, treats, or drives a clinical decision without a clinician independently reviewing the basis for it. Clinical decision support that shows its reasoning and leaves the decision with a clinician is generally not regulated. Taction runs a fixed FDA SaMD Pathway engagement at $60,000 over 8 weeks to settle classification before you build.
Related calculators
Need a number you can put in a board deck?
A fixed-scope quote comes out of a 4-week Discovery sprint, which starts at $45,000 and ends with an architecture, a backlog and a firm price.