FDA 510k Cost
Do you have any questions regarding the FDA 510k cost for submission and budget estimation? We would be happy to provide below detailed information on the fee charged by the 510k consultants, and FDA review. It is anticipated that in the year 2024, the FDA will issue 1700 or more FDA 510k 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 510k cost structure and ensure fair and competitive fixed rates for all the services we offer.
FDA 510k Cost Table for Budgeting
2025 Financial Year (October 1, 2024, through September 30, 2025)
US FDA 510k Review Fee: $24,335 (Standard)
US FDA 510k Review Fee: $6,084 (Small Business)**
FDA Establishment Registration Fee: $9,280
| 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 |
Additional note:
- The De Novo submission cost is approximately 120% to 150% more than the quoted price in each category
- 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. Travel, hotel, and local travel are billed at actual cost
- QMSR / 21 CFR 820 / GMP not included in the scope of service
- 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 $9,280 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 $10,000 ( 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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