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510k Submission Cost

FDA 510k Submission Cost

Do you have any inquiries regarding the FDA 510k submission cost with the review process? We would be happy to provide further information on the fee for review and 510k consulting services. It is anticipated that in the year 2024, the FDA will issue 1700 or more 510k medical device clearances, 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 consultants midway through the process. A common reason among these cases appears to be single expert, verbal consulting, additional man-hour charges and imposition of extra charges for responding to FDA review comments every time time. We follow a transparent pricing structure and ensure fair and competitive fixed rates for all the services we offer.

Our Pricing for FDA 510k Submissions

2024 Financial Year (October 1, 2023, through September 30, 2024)
US FDA 510k Review Fees: $21,760 (Standard)
US FDA 510k Review Fees: $5,440 (Small Business)**
FDA Establishment Registration Fees: $7,653 

Activity  Special 510k Abbreviated 510k   Traditional 510k  
Guidance (Offsite)* $ 6000 $ 7000 $ 8000
510k Preparation & Review $ 10000 $ 10000 $ 11000
Pre- Submission (2 Nos) with US Agent, Stationery & Courier $ 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 Preparation & Review $ 12000 $ 13000 $ 14000
Pre- Submission (2 Nos) with US Agent, Stationery & Courier $ 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 Preparation & Review $ 11000 $ 11000 $ 11000
Pre- Submission (2 Nos) with US Agent, Stationery & Courier $ 1000 $ 1000 $ 1000
TOTAL $ 18000 $ 19000 $ 21000
Payment Terms 40:30:20:10 40:30:20:10 40:30:20:10

Do you have any question? Contact Us!

Activity Special 510k Abbreviated 510k   Traditional 510k
Guidance (Offsite)* $ 8000 $ 9000 $ 10000
510k Preparation & Review $ 10000 $ 10000 $ 11000
Pre- Submission ( 2 Nos) with US Agent, Stationery & Courier $ 1000 $ 1000 $ 1000
TOTAL $ 19000 $ 20000 $ 22000
Payment Terms 40:30:20:10 40:30:20:10 40:30:20:10

Do you have any question? Contact Us!

Additional note:

 

  • Onsite visit charges are not included. However, if on-site service is needed, it is available for an additional cost
  • The man-day cost is $500. The travel, hotel, and local travel billed at actual cost
  • The prices listed above may change depending on the nature and variety of models, accessories, designs, and device codes
  • Please be aware that the FDA Establishment Registration cost of $7,653 will be payable only after 510k clearance has been granted
  • A quick review of the customer-provided 510k file in 2 working days is $2000 ( No guidance will be provided for closing GAPS)
  • A detailed review of customer-provided 510k in 10 working days is $10000 ( No guidance will be provided for closing GAPS)
  • A small business is defined as a business, including its affiliates, whose sales were less than $100 million last tax year**

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Get exact price offer for 510k with detailed statement of work. No hourly charges, no amendments in offer once the contract signed.       

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