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FDA 510k Fee and Cost Breakdown by Device Type (FY 2027)

The FDA 510k fee has two parts: the MDUFA user fee, which you pay directly to FDA, and the consulting fee for preparing and managing your submission. For FY 2027 the 510(k) review fee is USD 28,653, or USD 7,163 for a qualified small business.

Our 510k consultants work on fixed fees by device type, from USD 18,500, with no hourly billing. Use the tables below to plan the FDA 510k fee and your full budget to 510(k) clearance.

Request a 510k QuoteSee Fees by Device Type
510k Cost

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.

 

FDA 510k fee plus consulting fee: how the total 510(k) cost adds up in FY 2027

Fixed 510k Fees With No Hourly Billing

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.

 

Fixed 510k consulting fee by device type, from USD 18,500 to USD 30,500

Select your device type below to see the fixed I3CGLOBAL consulting fee, the FY 2027 FDA 510k fee (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
FDA fee source: Medical Device User Fee Rates for FY 2027, Federal Register

FDA 510k fee FY 2027: USD 28,653 standard vs USD 7,163 small business

1Select your device type to see the 510(k) cost

2Your fixed 510(k) consulting fee

Active Devices

Powered by electricity or battery — monitors, therapy and surgical equipment.

$19,500
✓ Fixed 510k consulting fee · No hourly charges
Get Your 510(k) Cost Quote
510k Cost Breakdown – Remote 510k Regulatory Services
  • 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)

Total 510(k) Cost (Consulting Fee + MDUFA Fee)$48,153$26,663
Active / IVD + Software Devices

Powered or IVD devices with embedded or companion software (IEC 60601 / IEC 62304).

$25,000
✓ Fixed 510k consulting fee · No hourly charges
Get Your 510(k) Cost Quote
510k Cost Breakdown – Remote 510k Regulatory Services
  • 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)

Total 510(k) Cost (Consulting Fee + MDUFA Fee)$53,653$32,163
Software Devices

510(k) for Software as a Medical Device (SaMD) and standalone software functions.

$19,500
✓ Fixed 510k consulting fee · No hourly charges
Get Your 510(k) Cost Quote
510k Cost Breakdown – Remote 510k Regulatory Services
  • 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)

Total 510(k) Cost (Consulting Fee + MDUFA Fee)$48,153$26,663
IVD Devices

In vitro diagnostic reagents, kits, controls and analyzers for specimen testing.

$20,500
✓ Fixed 510k consulting fee · No hourly charges
Get Your 510(k) Cost Quote
510k Cost Breakdown – Remote 510k Regulatory Services
  • 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)

Total 510(k) Cost (Consulting Fee + MDUFA Fee)$49,153$27,663
IVD + CLIA

IVD tests seeking 510(k) clearance with a CLIA waiver for point-of-care use.

$30,500
✓ Fixed 510k consulting fee · No hourly charges
Get Your 510(k) Cost Quote
510k Cost Breakdown – Remote 510k Regulatory Services
  • 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)

Total 510(k) Cost (Consulting Fee + MDUFA Fee)$59,153$37,663
Non-Active Devices

No energy source — instruments, catheters, dressings and consumables.

$18,500
✓ Fixed 510k consulting fee · No hourly charges
Get Your 510(k) Cost Quote
510k Cost Breakdown – Remote 510k Regulatory Services
  • 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)

Total 510(k) Cost (Consulting Fee + MDUFA Fee)$47,153$25,663
Sterile Devices

Devices supplied sterile — sterilization validation, packaging and shelf-life.

$21,500
✓ Fixed 510k consulting fee · No hourly charges
Get Your 510(k) Cost Quote
510k Cost Breakdown – Remote 510k Regulatory Services
  • 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)

Total 510(k) Cost (Consulting Fee + MDUFA Fee)$50,153$28,663
Implant Devices

510(k) for implants placed inside the body — orthopedic, dental and cardiovascular.

$25,000
✓ Fixed 510k consulting fee · No hourly charges
Get Your 510(k) Cost Quote
510k Cost Breakdown – Remote 510k Regulatory Services
  • 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)

Total 510(k) Cost (Consulting Fee + MDUFA Fee)$53,653$32,163
510(k) Fee Payment Terms 40 : 10 : 20 : 20 : 10
40%Upon Project Initiation
10%Before FDA Pre-Submission (Q-Sub)
20%Before Final eSTAR Submission
20%After Submission of Responses to the First FDA Review Comments
10%Upon FDA 510(k) Clearance
Special Pricing & Smart Savings on 510(k) Cost
10%OFF
Multi-Project Discount

Available when three (3) or more FDA 510(k) consulting projects are initiated simultaneously.

$4,000UP TO
Fast-Track Savings

When client coordination with I3CGLOBAL is seamless and the 510(k) is submitted to FDA on an accelerated timeline.

$4,000Submitted within 3 months
$3,000Submitted within 4 months
$2,000Submitted within 5 months
$1,000Submitted within 6 months

Faster collaboration. Faster submission. Bigger savings.

Not Included in the 510(k) Fee / Additional Fees
  • 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
Payment

How to Pay the FDA 510k Fee

You pay the FDA 510k fee online before you send the 510(k), and the payment must be linked to that submission. The steps are the same for standard and small business applicants.

  • 1. Confirm your fee level. If you qualify as a small business, get your Small Business Determination approved first. The reduced FDA 510k fee applies only once FDA has granted it.
  • 2. Create a user fee cover sheet. Complete the Medical Device User Fee Cover Sheet (Form FDA 3601) in FDA’s user fee system. It gives you a payment identification number (PIN) for this submission.
  • 3. Pay the fee. Pay online by credit card or bank account through Pay.gov, or by wire transfer, quoting the PIN.
  • 4. Reference the payment in your eSTAR. Enter the PIN and payment details in the eSTAR so FDA can match the fee to your 510(k).
  • 5. Submit through the CDRH Portal. FDA checks the payment during acceptance review. A 510(k) with no matching payment is not accepted for review until the fee is paid in full.

Fees are set per fiscal year. A 510(k) received on or after 1 October 2026 pays the FY 2027 FDA 510k fee, even if you started preparing it earlier, so check the date your submission will reach FDA when you set your budget.

How to Reduce Your Total 510k Cost

The FDA 510k fee is fixed each year, so the savings come from the work around it. These are the levers that make the biggest difference to the total cost:

  • Apply for small business status early. A qualified small business pays USD 7,163 instead of USD 28,653 in FY 2027, a saving of USD 21,490 on the FDA 510k fee alone.
  • Bundle related devices where FDA allows it. FDA’s bundling guidance lets some closely related devices or indications go in one 510(k), which means one review fee instead of several.
  • Settle the predicate and testing plan first. Most extra cost comes from repeating tests or changing predicates after FDA questions. A Pre-Submission (Q-Sub), which has no FDA fee, can settle these points early.
  • Submit a complete eSTAR. Missing sections lead to Refuse to Accept (RTA) holds or Additional Information requests, which add weeks and consultant time. With our fixed fees, FDA review responses stay within the agreed scope.
  • Run testing in parallel. Running biocompatibility, electrical safety or software verification alongside file preparation shortens the overall project.

Use the device-type table above to see the fixed consulting fee for your device, then add the FDA 510k fee that applies to your company to get your full 510(k) budget.

Not sure which device type applies to you? Send us your device description, intended use and any similar cleared device. We will confirm the category, the FDA 510k fee level and our fixed consulting fee in writing before any work starts, so there are no surprises later in the project.

Work with I3CGLOBAL

Plan Your FDA 510k Budget With I3CGLOBAL

Send us your device description, intended use and any predicate you have in mind. We will confirm the scope, our fixed consulting fee and the FDA 510k fee that applies, so you can budget your full 510k cost from the start.

  • Fixed 510k consulting fees by device type, with no hourly billing
  • Predicate strategy, testing plan, 510(k) technical file and eSTAR submission
  • FDA liaison, including RTA and Additional Information responses, through clearance
  • Consultants in Germany, India, Malaysia, Portugal, the UK and the USA

Request a 510k quote

Tell us your device, its product code if known and your target date. We will send you a formal proposal.

Get a QuoteContact Us

FAQs

FDA 510k Fee: Frequently Asked Questions

How much does a 510(k) cost in total?

The total 510(k) cost is the FDA 510k fee (the MDUFA user fee) plus the consulting fee for preparing the submission. For FY 2027 the FDA 510k fee is USD 28,653, or USD 7,163 for a qualified small business. At I3CGLOBAL, fixed 510k consulting fees start from USD 18,500, depending on the device type. Testing, such as biocompatibility, electrical safety or software verification, is paid separately to the test laboratory.

What is the FDA 510k fee in FY 2027?

The FY 2027 FDA 510k fee (the MDUFA 510(k) review fee) is USD 28,653 for standard applicants and USD 7,163 for qualified small businesses. FY 2027 covers submissions received from 1 October 2026 to 30 September 2027, and FDA publishes new rates in the Federal Register each summer.

Who pays the FDA 510k fee, and when?

The manufacturer or submitter pays the FDA 510k fee directly to FDA before the submission is reviewed. FDA does not start the review until the fee is paid in full. The FDA 510k fee is separate from the consulting fee.

How do I qualify for the small business FDA 510k fee?

Your company, including affiliates, must have gross receipts or sales of USD 100 million or less in the most recent tax year. FDA must approve your Small Business Determination (SBD) request before you pay, so apply well before you plan to submit. The SBD is valid for the fiscal year in which it is granted.

What affects your 510(k) cost?

Your total 510k submission cost depends on the device type, software content, sterility, implant status, the number of models and product codes, the testing needed and whether a Pre-Submission (Q-Sub) is used. The fixed consulting fees on this page cover guidance, 510(k) technical file preparation, eSTAR submission and FDA liaison through clearance.

Is a third-party 510(k) review subject to the FDA 510k fee?

No. A 510(k) reviewed by an FDA-recognised third-party review organisation is not charged the FDA 510k fee. The review organisation charges its own fee instead, and only certain device types are eligible for the third-party review programme.

Does the FDA 510k fee include establishment registration?

No. The annual establishment registration fee is a separate FDA user fee. It is paid each year when you register your establishment and list your devices, whether or not you file a 510(k) that year.

Is a Pre-Submission (Q-Sub) required for a 510(k)?

No. A Q-Sub is optional and has no FDA user fee. It is recommended when you want FDA feedback on testing or predicate strategy before the final eSTAR submission.