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FDA 510k Fees

Do you have any questions regarding the FDA 510k Fee or Submission cost and Budget Estimation? We would be happy to provide below detailed information on the fee charged by the experts, and FDA review. It is anticipated that in the year 2024, the FDA will issue 1700 or more 510k clearance, with 58% or more of these applications coming from overseas.

 

We have noticed a significant number of inquiries from 510k Applicants who, for various reasons, terminated their agreements with other experts midway through the process. A common reason among these cases appears to be single expert, verbal, additional man-hour charges and imposition of extra charges for responding to FDA review comments every time time. We follow a transparent FDA 510k Fee Structure and ensure fair and competitive fixed rates for all the 510k submission services we offer.

FDA 510k Fees Table for Budgeting

2026 Financial Year (October 1, 2025, through September 30, 2026)
510k submission fees
US FDA Fees Table
Fee Category Amount (USD)
US FDA 510(k) Review Fee (Standard) $26,067
US FDA 510(k) Review Fee (Small Business)*** $6,517
FDA Establishment Registration Fee $11,423
*** A small business is defined as a business, including its affiliates, whose gross sales or receipts were less than $100 million USD in the most recent tax year. Small Business status must be approved by the US FDA to qualify for the reduced 510(k) review fee.

Activity  Special 510k Abbreviated 510k   Traditional 510k  
Guidance (Offsite)* $ 6000 $ 7000 $ 8000
510k Technical File Preparation $ 10000 $ 10000 $ 11000
Pre-Submission (2 Nos) + eCopy +  US Agent $ 1000 $ 1000 $ 1000
TOTAL $ 17000 $ 18000 $ 20000
Payment Terms 40:30:20:10 40:30:20:10 40:30:20:10

Activity Special 510k  Abbreviated 510k Traditional 510k 
Guidance (Offsite)* $ 6000 $ 7000 $ 8000
510k Technical File Preparation $ 12000 $ 13000 $ 14000
Pre-Submission (2 Nos) + eCopy +  US Agent $ 1000 $ 1000 $ 1000
TOTAL $ 19000 $ 21000 $ 23000
Payment Terms 40:30:20:10 40:30:20:10 40:30:20:10

IEC 62304 Implementation Cost not included. Read more>

Activity Special 510k Abbreviated 510k Traditional 510k    
Guidance (Offsite)* $ 6000 $ 7000 $ 8000
510k Technical File Preparation $ 11000 $ 11000 $ 11000
Pre-Submission (2 Nos) + eCopy +  US Agent $ 1000 $ 1000 $ 1000
TOTAL $ 18000 $ 19000 $ 21000
Payment Terms 40:30:20:10 40:30:20:10 40:30:20:10

Activity Special 510k Abbreviated 510k   Traditional 510k
Guidance (Offsite)* $ 8000 $ 9000 $ 10000
510k Technical File Preparation $ 10000 $ 10000 $ 11000
Pre-Submission (2 Nos) + eCopy +  US Agent $ 1000 $ 1000 $ 1000
TOTAL $ 19000 $ 20000 $ 22000
Payment Terms 40:30:20:10 40:30:20:10 40:30:20:10

🌟 Special Pricing & Smart Savings 

 

⊗   A 10% discount applies when three (03) or more 510(k) projects are initiated simultaneously

⊗  Enjoy exclusive discounts of up to $5,000 when client coordination with I3CGlobal is seamless and the submission done to FDA on an accelerated timeline:

  • $5,000 discount – Submission completed within 3 months

  • $4,000 discount – Submission completed within 4 months

  • $3,000 discount – Submission completed within 5 months

  • $2,000 discount – Submission completed within 6 months

Faster collaboration. Faster submission. Bigger savings.

 

⚠️  Items Excluded / Subject to Additional Fees

 

⊗  Any reclassification or change in FDA code or addition of supplementary code after the work has commenced.

⊗  Additional models / variants / accessories not explicitly listed in the originally agreed 510k proposal.

⊗  Rework required due to late, incomplete, or inconsistent inputs from the client.

⊗  Multiple intended purposes or multiple clinical indications not listed in the original agreed proposal

⊗  Accelerated timelines, fast-track reviews, or priority submissions requested by the client.

⊗  Any documents, reports, or activities not explicitly mentioned in the original proposal.

⊗  GMP/QMSR/IEC 62304 Implementations not part of 510k scope

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