FDA 510k Cost For Submission
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 |
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 |
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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