FDA 510k Fee Breakdown by
Device Type
Planning your FDA 510k fee and budget? The total 510(k) cost has two parts: the FDA 510(k) user fee (MDUFA fee), which you pay directly to FDA, and the 510k consulting fee for preparing and managing your submission until 510(k) clearance.
Many 510k applicants come to I3CGLOBAL after leaving other consultants midway because of hourly billing, unplanned man-hour charges, or extra fees every time FDA raised review comments. We work differently: a transparent, fixed 510k fee structure with no hourly charges, and FDA review responses handled within the agreed scope of our 510(k) submission services.
Select your device type below to see the fixed I3CGLOBAL consulting fee, the FY 2027 MDUFA review fee, and your total 510(k) cost.
Transparent Fixed Fee Costing
for 510k consulting and FDA File Review
Financial Year 2027 (FY2027): 1 October 2026 to 30 September 2027
1Select your device type to see the 510(k) cost
2Your fixed 510(k) consulting fee
Powered by electricity or battery — monitors, therapy and surgical equipment.
- Guidance$4,000
- 510k Technical File Preparation$10,000
- 1–3 Q-Submissions + US Agent (Optional, but Recommended)$1,500
- eSTAR Submission$1,000
- FDA Liaison & Regulatory Coordination Through Clearance$3,000
- Consulting Total$19,500
FDA 510(k) Review Fee – MDUFA User Fee (FY 2027 · paid directly to FDA)
Powered or IVD devices with embedded or companion software (IEC 60601 / IEC 62304).
- Guidance$6,000
- 510k Technical File Preparation$13,000
- 1–3 Q-Submissions + US Agent (Optional, but Recommended)$1,500
- eSTAR Submission$1,000
- FDA Liaison & Regulatory Coordination Through Clearance$3,500
- Consulting Total$25,000
FDA 510(k) Review Fee – MDUFA User Fee (FY 2027 · paid directly to FDA)
510(k) for Software as a Medical Device (SaMD) and standalone software functions.
- Guidance$4,000
- 510k Technical File Preparation$10,000
- 1–3 Q-Submissions + US Agent (Optional, but Recommended)$1,500
- eSTAR Submission$1,000
- FDA Liaison & Regulatory Coordination Through Clearance$3,000
- Consulting Total$19,500
FDA 510(k) Review Fee – MDUFA User Fee (FY 2027 · paid directly to FDA)
In vitro diagnostic reagents, kits, controls and analyzers for specimen testing.
- Guidance$5,000
- 510k Technical File Preparation$10,000
- 1–3 Q-Submissions + US Agent (Optional, but Recommended)$1,500
- eSTAR Submission$1,000
- FDA Liaison & Regulatory Coordination Through Clearance$3,000
- Consulting Total$20,500
FDA 510(k) Review Fee – MDUFA User Fee (FY 2027 · paid directly to FDA)
IVD tests seeking 510(k) clearance with a CLIA waiver for point-of-care use.
- Guidance$6,000
- 510k Technical File Preparation$11,000
- 1–3 Q-Submissions + US Agent (Optional, but Recommended)$1,500
- eSTAR Submission$1,000
- FDA Liaison & Regulatory Coordination Through Clearance$11,000
- Consulting Total$30,500
FDA 510(k) Review Fee – MDUFA User Fee (FY 2027 · paid directly to FDA)
No energy source — instruments, catheters, dressings and consumables.
- Guidance$4,000
- 510k Technical File Preparation$9,000
- 1–3 Q-Submissions + US Agent (Optional, but Recommended)$1,500
- eSTAR Submission$1,000
- FDA Liaison & Regulatory Coordination Through Clearance$3,000
- Consulting Total$18,500
FDA 510(k) Review Fee – MDUFA User Fee (FY 2027 · paid directly to FDA)
Devices supplied sterile — sterilization validation, packaging and shelf-life.
- Guidance$5,000
- 510k Technical File Preparation$11,000
- 1–3 Q-Submissions + US Agent (Optional, but Recommended)$1,500
- eSTAR Submission$1,000
- FDA Liaison & Regulatory Coordination Through Clearance$3,000
- Consulting Total$21,500
FDA 510(k) Review Fee – MDUFA User Fee (FY 2027 · paid directly to FDA)
510(k) for implants placed inside the body — orthopedic, dental and cardiovascular.
- Guidance$6,000
- 510k Technical File Preparation$13,000
- 1–3 Q-Submissions + US Agent (Optional, but Recommended)$1,500
- eSTAR Submission$1,000
- FDA Liaison & Regulatory Coordination Through Clearance$3,500
- Consulting Total$25,000
FDA 510(k) Review Fee – MDUFA User Fee (FY 2027 · paid directly to FDA)
Available when three (3) or more FDA 510(k) consulting projects are initiated simultaneously.
When client coordination with I3CGLOBAL is seamless and the 510(k) is submitted to FDA on an accelerated timeline.
Faster collaboration. Faster submission. Bigger savings.
- Each additional model / variant (no extra fee for size variations)$1,000 – $2,000
- Each additional FDA product code (supplementary codes)$4,000 – $6,000
- Rework due to late, incomplete or inconsistent inputs from the client
- Multiple intended uses or clinical indications not listed in the original Quote Request Form (QRF)
- Accelerated timelines, fast-track reviews or priority submissions requested by the client
- Any documents, reports or activities not explicitly listed in the original proposal
- GMP / QMSR / IEC 62304 implementation (outside the 510(k) scope)
- On-site visit to the client’s office or manufacturing facility, if required (travel and lodging billed at actuals)$900 / man-day
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Frequently Asked Questions
What Affects Your 510(k) Cost?
Your total 510k submission cost depends on the device type, software content, sterility, implant status, number of models and product codes, testing needs, and whether a Pre-Submission (Q-Sub) is used. The fixed consulting fees above cover guidance, 510(k) technical file preparation, eSTAR submission, and FDA liaison through clearance.
Who pays the MDUFA FDA 510k fee?
The manufacturer or submitter pays the 510k user fee directly to FDA before the submission is reviewed. It is separate from the consulting fee.
How much does a 510(k) cost?
The total 510(k) cost is the FDA MDUFA user fee ($28,653 standard or $7,163 small business for FY 2027) plus the consulting fee for preparing the submission. At I3CGLOBAL, fixed 510k consulting fees start from $18,500 depending on device type.
How do I qualify for the small business 510(k) fee?
Your company, including affiliates, must have gross receipts or sales of $100 million USD or less in the most recent tax year, and FDA must approve your Small Business Determination (SBD) request before you pay.
Is a Pre-Submission (Q-Sub) required for a 510(k)?
No, a Q-Sub is optional, but it is recommended to get FDA feedback on testing and predicate strategy before the final eSTAR submission.
What is the MDUFA fee for a 510(k) in FY 2027?
The FY 2027 MDUFA 510(k) review fee is $28,653 for standard applicants and $7,163 for qualified small businesses.
Page updated on October by Binoy Joese