How Much Does a 510(k) Cost? Complete Budget Breakdown
- Beng Ee Lim
- 3 days ago
- 11 min read
A 510(k) submission costs between $50,000 and $250,000+ depending on device complexity, testing requirements, and whether you use consultants. Core costs include FDA user fees ($6,517-$26,067), testing/validation ($20,000-$150,000+), consultant fees ($15,000-$50,000), and establishment registration ($11,423). Most startups underestimate by 40-60%, with hidden costs from AI requests, design changes, and regulatory delays adding $30,000-$100,000+ to initial budgets.
You've built a medical device. You know you need FDA clearance. You Google "510(k) cost" and get ranges from $30K to $200K+ with no context on which number applies to your device.
Here's the truth: 510(k) costs aren't one-size-fits-all.
A simple, non-contact device with existing biocompatibility data might clear for $50K-$75K. A novel implantable device requiring extensive testing, clinical data, and consultant support can easily exceed $250K before you receive clearance.
This guide breaks down every cost category with pricing, shows you where companies typically blow budgets, and provides decision frameworks so you can build an accurate budget based on your specific device complexity.
What Determines Your 510(k) Cost?
Before diving into line-item costs, understand the five factors that drive your total spend:
Device Complexity: A single-material, non-powered device requires minimal testing compared to a multi-component electromechanical system with software.
Patient Contact: Surface-contact devices need basic biocompatibility testing ($3,000-$15,000). Long-term implants require extensive testing including animal studies ($50,000-$100,000+).
Technology Novelty: Devices substantially equivalent to existing predicates with similar technological characteristics require less testing than devices with novel features requiring additional validation.
Existing Documentation: Companies with established QMS, design history files, and prior testing data spend 30-50% less than startups building documentation from scratch.
In-House Capabilities: Teams with regulatory expertise, testing facilities, and technical writing skills significantly reduce consultant and outsourcing costs.
Understanding where your device falls on these dimensions determines whether you're looking at a $50K or $250K+ submission.
Total 510(k) Cost by Device Complexity
*These ranges reflect typical US 510(k) submissions in 2025/2026 under common scenarios. Actual costs vary depending on device features, testing scope, and required documentation.
Simple Devices (~$50K–$100K)
Examples: Non-powered surgical instruments, examination gloves, simple dressings, non-contact diagnostic devices
Minimal or no patient contact, simple materials, no power source or electronics.
A strong predicate with extensive publicly available testing data.
Little or no biocompatibility or performance testing beyond basic compliance.
In this band, your main costs are:
FDA user fee (FY2026): $26,067 (standard) or $6,517 (small business)
Basic bench / documentation / submission prep; maybe minimal external testing.
Moderate Complexity (~$100K–$175K)
Examples: Powered diagnostic equipment, electrosurgical devices, patient monitoring systems, short-term implants, reusable surgical instruments
Device includes electrical components, multiple materials, or requires biocompatibility/sterility testing.
Some testing gaps vs predicate — e.g., EMC/safety, material compatibility, limited performance testing or usability testing.
Budget typically includes:
FDA fees and perhaps annual registration fee if required (but registration is not per-device; it's per establishment). FY2026 registration fee is $11,423.
Testing (bench / EMC / materials / biocompatibility) often ranges $50,000–$90,000 depending on labs, sample size, and testing scope.
Documentation, submission prep, labeling, possibly regulatory consulting or external support.
High / Complex Devices ($175K+)
Examples: Active implantable devices, combination products, novel drug-device combinations, devices requiring clinical data, AI/ML-enabled devices
Devices with novel technology, complex electronics, embedded software, long-term implants, combination products, or clinical data requirements.
Testing may include full biocompatibility batteries, animal studies, sterilization / shelf-life validation, software validation, human factors, cybersecurity analysis, maybe even a clinical study.
Costs can escalate significantly: extensive testing may run $100,000–$200,000+; if clinical is required and a trial is needed, expect $250,000 up to several million depending on size and endpoints. Regulatory consulting, documentation, quality system setup also add.
Outcome: for high-risk / novel devices, total “all-in” 510(k) cost can easily exceed $300,000, and sometimes run into $500,000+ or even $1M+ depending on complexity and need for iterative testing or data cycles.
FDA User Fees: What You'll Pay the Government
Every 510(k) submission requires FDA user fees. These fees increased 7.12% from FY 2025 to FY 2026, and they're mandatory before FDA begins review.
FY 2026 510(k) Submission Fees (Oct 1, 2025 - Sep 30, 2026)
Standard Fee: $26,067
Applies to companies with gross receipts/sales exceeding $100 million
Small Business Fee: $6,517
Applies to companies with gross receipts/sales ≤$100 million (including affiliates)
Requires annual Small Business Determination (SBD) certification
Must apply by July 31 before fiscal year starts
Status expires September 30 each year
Establishment Registration Fee: $11,423
Required for all manufacturers distributing devices in U.S.
Due between October 1 and December 31 annually
23.1% increase from FY 2025 ($9,280)
No small business discount available
Registration fee waiver exists for businesses with ≤$1M revenue demonstrating financial hardship (extremely limited)
How to Qualify for Small Business Discount
The 75% fee reduction ($19,550 savings) is available if:
Your business and affiliates have ≤$100M gross receipts/sales in most recent tax year
You submit Form 3602N electronically through CDRH Portal
You receive Small Business Decision (SBD) number before submission
You apply at least 60 days before submitting your 510(k)
Critical timing: FDA doesn't refund fee differences. If you submit at standard rate then later receive small business status, you lose the $19,550 difference. Apply early.
Payment Methods
FDA no longer accepts checks as of October 1, 2025. Payment options:
Electronic check (ACH/eCheck) - preferred
Credit card (for amounts <$25,000)
Wire transfer (include PIN from cover sheet)
Important: FDA places submissions on "User Fee Hold" until payment clears. Submit payment when you submit application to avoid delays.
Testing & Validation Costs: The Biggest Variable in Your 510(k) Budget
Testing is often the largest expense in a 510(k) submission. For many devices, testing accounts for 40–60% of total project cost, especially when biocompatibility, electrical safety, EMC, or performance validation are required.
Below is a realistic breakdown of testing categories, typical cost ranges, and where most companies underestimate budget.
1. Biocompatibility Testing
Required for all devices with patient contact. Costs depend on contact duration, contact type, and whether testing can be reduced through chemical characterization.
Basic Panel (Surface Contact, <24 hours): $6,000–$15,000
Typical ISO 10993 tests include:
Cytotoxicity (ISO 10993-5): $2,000–$3,000
Sensitization (ISO 10993-10): $3,000–$5,000
Irritation (ISO 10993-10): $3,000–$5,000
Extended Testing (Prolonged Contact >24 hours): $15,000–$60,000
Includes basic tests plus:
Systemic toxicity (ISO 10993-11): $5,000–$15,000
Subchronic toxicity: $10,000–$25,000
Material-mediated pyrogenicity: $3,000–$5,000
Implant-Level Testing (Permanent Contact): $50,000–$150,000+
May include:
Implantation studies (ISO 10993-6): $20,000–$40,000
Genotoxicity (ISO 10993-3): $5,000–$15,000
Hemocompatibility (blood-contacting): $10,000–$25,000+
Carcinogenicity (rarely required): typically $100,000+ and multi-year
💡 Cost-Saving Strategy
Using chemical characterization (ISO 10993-18) plus toxicological risk assessment can sometimes replace animal testing and reduce costs 30–50% — but requires a qualified biocompatibility expert.
2. Electrical Safety & EMC Testing
Essential for all powered devices. Tests must be run on the complete system, not individual components.
Electrical Safety (IEC 60601-1): $15,000–$25,000
Covers:
Shock protection
Mechanical hazard protection
Temperature & radiation safety
Construction & environmental safety
Electromagnetic Compatibility (IEC 60601-1-2): $25,000–$40,000
Includes:
Radiated & conducted emissions
Radiated & conducted immunity
Electrostatic discharge (ESD)
RF immunity for modern wireless environments
Additional 60601 Testing (as applicable)
Test Standard | Typical Cost |
Home healthcare (IEC 60601-1-11) | $10,000–$15,000 |
Battery-powered devices (various clauses) | $5,000–$10,000 |
Wireless devices | $15,000–$25,000 |
⚠️ Important
If EMC testing requires design changes (e.g., shielding), electrical safety tests must be repeated, adding $15,000–$25,000.
3. Sterilization Validation
Required for devices labeled as sterile.
Ethylene Oxide (EO) — $15,000–$30,000
Includes:
Bioburden (ISO 11737-1): $2,000–$4,000
EO validation (ISO 11135): $10,000–$18,000
Residual EO testing: $3,000–$5,000
Gamma Radiation — $12,000–$20,000
Dose mapping & validation
Material compatibility evaluation
Steam Sterilization — $10,000–$15,000
ISO 17665 validation
Package integrity testing
4. Shelf-Life & Packaging Testing
Real-Time Aging — $5,000–$10,000
Required for final shelf-life claims.
Accelerated Aging — $8,000–$15,000
Uses Q10 methodology
Must be supported by real-time data eventually
💡 Cost-Saving Strategy
Submit with a conservative shelf life (e.g., 6–12 months) based on accelerated data, then extend via a new 510(k) once real-time data matures.
5. Performance Testing
Highly dependent on device type and predicate.
Bench Testing — $10,000–$50,000
Examples: mechanical strength, fatigue, flow rates, simulated use, etc.
Cadaver Testing — $20,000–$60,000
Common for orthopedic, spinal, and surgical tools.
Animal Studies — $100,000–$300,000+
For implants, cardiovascular devices, or devices requiring biological response evaluation. Timeline: 6–12 months.
6. Usability / Human Factors Testing
Formative human factors: $5,000–$15,000
Summative validation: $10,000–$25,000+
Required for home-use and moderate/high-risk devices.
7. Software Validation & Cybersecurity
Software Validation (IEC 62304) — $20,000–$60,000
Requirements traceability
Unit, integration, and system testing
Hazard analysis and verification
Cybersecurity Documentation — $25,000–$75,000+
Required for “Cyber Devices” under Section 524B (software + network connectivity).
Includes:
Threat modeling
SBOM
Security risk assessment
Penetration testing
Post-market monitoring plan
Complex software or AI/ML devices can exceed $100K.
8. Clinical Studies (If Required)
Clinical data is required in <10% of 510(k)s, typically when:
Bench data cannot demonstrate substantial equivalence
Device has novel technologies
FDA device-specific guidance requires clinical evidence
Predicate device included clinical data
Pilot (Feasibility) Studies — $250K–$500K
20–50 patients; often single-site.
Pivotal Studies — $500K–$2.5M+
100–300+ patients; multi-center; IDE required.
Consultant & Preparation Costs: $20,000–$75,000+
If you don’t have experienced regulatory professionals in-house, consulting and documentation support will make up a significant portion of your 510(k) budget. Costs vary based on device complexity, the quality of your existing documentation, and whether your team needs full strategic guidance or just technical-writing support.
Where Traditional Consultant Costs Come From
Even with a well-defined device, consultants typically charge for:
Pre-Submission Strategy (Pre-Sub) — $5,000–$12,000
Determining the correct product code and predicate
Mapping the regulatory pathway
Drafting Pre-Sub questions and meeting packages
Defining an initial testing plan
510(k) Preparation — $25,000–$75,000
Writing device descriptions and technical sections
Developing substantial equivalence arguments
Integrating test reports, labeling, and risk management
Formatting and uploading eCopy or eSTAR
Where Complizen Fits In
Instead of relying entirely on consultants to explain FDA expectations, identify predicates, structure your documentation, or navigate device-specific guidance, Complizen provides:
✔ Predicate Intelligence
Instant comparisons of indications for use, technology, testing, recalls, and adverse events — work that usually costs consultants dozens of billable hours.
✔ Tests & Standards Mapping
Automatically identifies testing requirements based on FDA-recognized standards and predicate history, reducing consultant scoping time.
✔ Strategy Workspace
Guides you step-by-step through your regulatory plan, surfacing relevant guidance documents, risk factors, and required evidence.
✔ Drafted Regulatory Strategy Document
Complizen builds the first complete draft of your 510(k) regulatory strategy — a task that normally takes consultants 40–80 hours of writing.
✔ Collaboration With Consultants (If Needed)
Instead of starting from zero, your consultant begins with structured analysis, predicate data, and drafted content — cutting hours dramatically.
👉 Result: Most companies reduce consultant workload by 30–60%, saving $10,000–$40,000+ on their 510(k).
When You Still Need Consultants
Complizen doesn't replace specialized experts for:
Complex software risk analyses
Clinical study design
GLP study oversight
Legal interpretation in edge-case scenarios
But instead of relying on consultants for every question, teams can now:
Clarify requirements instantly
Build regulatory strategy internally
Prepare reviewer-ready documentation
Use consultants only for high-value, device-specific tasks
Exactly what regulatory professionals call “the modern regulatory stack.”
Hidden Costs That Blow Budgets
Most companies focus on obvious costs (fees, testing, consultants) but get blindsided by these hidden expenses:
1. RTA (Refuse to Accept) Holds
60% of 510(k)s receive RTA holds for administrative deficiencies.
Cost Impact:
Review clock resets to zero
30-60 day delay minimum
Consultant time addressing deficiencies: $5,000-$15,000
Additional testing if gaps identified: $10,000-$50,000
Opportunity cost of delayed market entry
How to Avoid: Use FDA's RTA checklist for pre-submission gap analysis, conduct internal review using same criteria.
2. Additional Information (AI) Requests
63-68% of submissions receive AI requests during substantive review.
Cost Impact:
60-180 day delay
Consultant response time: $8,000-$25,000
Additional testing (if required): $20,000-$150,000+
Extended contractor burns (if applicable)
Most Common AI Request Triggers:
Incomplete performance testing
Inadequate predicate comparison
Missing biocompatibility endpoints
Unclear substantial equivalence rationale
Cybersecurity deficiencies
How to Avoid: Submit Pre-Sub meeting request with testing matrix; FDA confirms sufficiency before you invest in testing.
3. Design Changes During Development
Design modifications after testing begins require retesting.
Examples:
Material changes: Repeat biocompatibility testing ($10,000-$50,000)
EMC failures: Design modifications + retest ($25,000-$75,000)
Software updates: Partial revalidation ($15,000-$40,000)
Mechanical failures: Redesign + retest ($20,000-$60,000)
How to Avoid: Lock design before starting formal validation testing; conduct design verification before validation.
4. Weak Predicate Selection
Selecting wrong predicate wastes 6-18 months and forces restart.
Cost Impact:
All testing completed is device-specific (can't reuse)
New predicate may require different testing strategy
Consultant fees for new submission: $15,000-$40,000
Opportunity cost: Lost revenue during 12+ month delay
How to Avoid: Validate predicate suitability in Pre-Sub meeting before committing to expensive testing; download predicate's FDA Form 3881 and conduct line-by-line indications for use comparison.
5. QMS Documentation Gaps
510(k) submissions require design history file (DHF) supporting device development.
Cost Impact (if QMS doesn't exist):
Retroactive DHF creation: $20,000-$60,000
Risk management file development: $10,000-$25,000
Design control documentation: $15,000-$40,000
How to Avoid: Implement QMS (ISO 13485) from Day 1 of development; document as you go, not retrospectively.
6. Post-Clearance Requirements
Clearance isn't the end. Additional costs post-clearance:
Annual Costs:
Establishment registration renewal: $11,423/year
QMS maintenance and audits: $10,000-$30,000/year
Periodic reporting (Class III): $20,275/year standard
One-Time Post-Clearance:
Product labeling finalization: $5,000-$15,000
Device listing (after starting distribution): Included in registration
US Agent services (foreign manufacturers): $3,000-$8,000/year
Cost-Saving Strategies That Actually Work
1. Use Pre-Sub Meetings Before Testing
Pre-Subs are free and prevent unnecessary testing.
Ask FDA to confirm:
Predicate acceptability
Testing completeness
Clinical data necessity
Substantial equivalence approach
2. Leverage Predicate Testing Data Savings
Avoid repeating tests predicates already completed.
How
Download predicate 510(k)s
Identify completed standards and accepted methods
Show equivalence where appropriate
Only test your differences
Complizen Support
Predicate Intelligence reveals testing patterns across cleared devices in your category.
3. Replace Animal Testing With Chemical Characterization
ISO 10993-18 + toxicological risk assessment can replace in vivo tests when materials are well characterized.
When It Works
Known, well-studied materials
No novel polymers
Low extraction risk
4. Combine Testing Where Possible
Examples:
Use same samples for sterility + biocompatibility
Combine aging with performance testing
Integrate usability into validation study designs
5. Build Basic Regulatory Capability In-House
Hiring an internal RA specialist often becomes ROI-positive after two submissions.
When It Makes Sense
Two or more submissions expected in 24 months
Ongoing pipeline requiring regulatory oversight
6. Use Small Business Status
Small businesses (<$100M revenue) receive a 75% 510(k) fee reduction.
Critical Timing
Apply before July 31
FDA needs ~60 days to process
Discount cannot be applied retroactively
7. Start With Conservative Shelf Life
Submit with 1–2 year shelf life based on accelerated aging, then extend later with real-time data.
Tradeoff: Market competitively with shorter shelf life initially, extend after real-time data matures.
FAQ
How long does it take to prepare a 510(k)?
Most teams need 6–18 months, depending on documentation readiness and testing.
With established QMS + complete data: 3–6 months
Startups building from scratch: 12–18 months
Testing timelines:
Biocompatibility: 2–4 months
Electrical/EMC: 1–3 months
Clinical studies (if required): 12–24+ months
Can you submit a 510(k) with incomplete testing?
No. FDA requires full test reports. Submitting incomplete data triggers an RTA hold or AI request, both of which reset your clock.
What if you can’t afford the full 510(k) cost?
Companies often pursue:
Earlier markets (EU or APAC) to generate revenue
SBIR/STTR or angel/VC funding
A simplified initial device version
A De Novo pathway if no suitable predicate exists
How much does a failed submission cost?
RTA hold: $10K–$30K
AI request: $30K–$150K+
NSE determination: restart and potentially $50K–$200K+Most failures are avoidable through Pre-Subs, strong testing strategy, and experienced review.
Are there grants for regulatory work?
Yes. Programs like SBIR/STTR, NIH, DoD, and medtech accelerators commonly fund regulatory tasks and testing milestones for device startups.
Can the same testing work for FDA and CE Mark?
Partially.
ISO 10993 biocompatibility applies to both.
IEC 60601 electrical safety overlaps.
CE Mark often requires less clinical data, but requirements differ. Most companies test to FDA standards, which usually satisfies CE—but CE testing alone rarely satisfies FDA.
What’s the cost difference between 510(k) and De Novo?
De Novo submissions usually cost 30–60% more due to additional safety and effectiveness data. Forcing a weak predicate into a 510(k) often results in NSE and full restart—more expensive than choosing De Novo upfront.
Are software-only devices cheaper?
Often yes. SaMD typically costs $60K–$150K, mainly for:
Software validation: $25K–$75K
Cybersecurity documentation: $30K–$75KClinical data may still be required depending on intended use.
Does CE Mark reduce FDA costs?
Not significantly. Some testing carries over, but FDA still requires:
EMC to IEC 60601-1-2 (4th edition)
Cybersecurity documentation
Usability validationBudget 70–90% of full FDA costs, even with CE Mark.
How many 510(k)s get cleared on the first attempt?
~40% pass RTA screening without a hold
Of those, 63–68% receive AI requests
Most submissions require at least one correction before clearance, which is normal — not a failure. Strong Pre-Subs and experienced review improve first-pass success.