FDA 510k Fees For Medical Devices
It is anticipated that in the year 2023, the FDA will issue 1700 or more 510k clearances, with 57% or more of these applications coming from overseas. Do you have any inquiries regarding the FDA 510k fees associated with the review process? We would be happy to provide further information on the charges for our review and 510k consulting services.
We have received numerous inquiries from 510k applicants who have terminated their agreements with other consultants. Common reasons for this include excessive FDA 510k fees for file preparation and charging extra for responding to FDA inquiries. Please be assured that we strive to provide transparent pricing and fair, competitive rates for all of our services.
Estimate for 510k Submission Cost
2023 Financial Year (October 1, 2022, through September 30, 2023)
FDA Establishment Registration Fees: $6,493
OPTION 1: 510k PACKAGE FEES (Full Option)
| Activity | Special 510k | Abbreviated 510k | Traditional 510k |
| Guidance (Offsite)* | $ 6000 | $ 7000 | $ 8000 |
| 510k Preparation & Review | $ 9000 | $ 9000 | $ 10000 |
| Pre- Submission (2 Nos) with US Agent, Stationery & Courier | $ 1000 | $ 1000 | $ 1000 |
| TOTAL | $ 16000 | $ 17000 | $ 19000 |
| Payment Terms | 40:30:20:10 | 40:30:20:10 | 40:30:20:10 |
⇒ In addition to our standard services, our team of experts is available for on-site technical consultations and explanations for an extra fee of 2-3 man-days. Please note that travel, hotel, and a man-day fee of $400 will be charged in addition to this.
⇒ The prices listed above are subject to change depending on the complexity and variety of models, accessories, designs, and device codes involved in the 510k application.
⇒ Please be aware that FDA Establishment Registration Fees of $6,493 will be payable only after 510k clearance has been granted.
OPTION 2: PARTIAL SERVICE FEES
| Activity | Special 510k | Abbreviated 510k | Traditional 510k |
| Quick Review of Customer made 510k in 3 working days | $ 2500 | $ 2500 | $ 2500 |
| Detailed Review of Customer made 510k in 12 working days | $ 4000 | $ 4500 | $ 5000 |
| (a) US Agent
(b) Pre- Submission (2Nos Max.) (c) Final Submission (d) Stationery & Courier |
$ 2000 | $ 2000 | $ 2000 |
OPTION 1: PACKAGE FEES (Full Option)
| Activity | Special 510k | Abbreviated 510k | Traditional 510k |
| Guidance (Offsite)* | $ 6000 | $ 7000 | $ 8000 |
| 510k Preparation & Review | $ 10000 | $ 10000 | $ 10000 |
| Pre- Submission (2 Nos) with US Agent, Stationery & Courier | $ 1000 | $ 1000 | $ 1000 |
| TOTAL | $ 17000 | $ 18000 | $ 19000 |
| Payment Terms | 40:30:20:10 | 40:30:20:10 | 40:30:20:10 |
⇒ In addition to our standard services, our team of experts is available for on-site technical consultations and explanations for an extra fee of 2-3 man-days. Please note that travel, hotel, and a man-day fee of $400 will be charged in addition to this.
⇒ The prices listed above are subject to change depending on the complexity and variety of models, accessories, designs, and device codes involved in the 510k application.
⇒ Please be aware that FDA Establishment Registration Fees of $6,493 will be payable only after 510k clearance has been granted.
⇒ Please note that the implementation and guidance for IEC 62304 is not included in the pricing listed above. This service is available for an additional cost.
OPTION 2: PARTIAL SERVICE FEES
| Activity | Special 510k | Abbreviated 510k | Traditional 510k |
| Quick Review of Customer made 510k in 3 working days | $ 1500 | $ 2000 | $ 2500 |
| Detailed Review of Customer made 510k in 12 working days | $ 4000 | $ 4500 | $ 5000 |
| (a) US Agent
(b) Pre- Submission (2Nos Max.) (c) Final Submission (d) Stationery & Courier |
$ 2000 | $ 2000 | $ 2000 |
OPTION 1: PACKAGE FEES (Full Option)
| 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 |
⇒ In addition to our standard services, our team of experts is available for on-site technical consultations and explanations for an extra fee of 2-3 man-days. Please note that travel, hotel, and a man-day fee of $400 will be charged in addition to this.
⇒ The prices listed above are subject to change depending on the complexity and variety of models, accessories, designs, and device codes involved in the 510k application.
⇒ Please be aware that FDA Establishment Registration Fees of $6,493 will be payable only after 510k clearance has been granted.
OPTION 2: PARTIAL SERVICE FEES
| Activity | Special 510k | Abbreviated 510k | Traditional 510k |
| Quick Review of Customer made 510k in 3 working days | $ 2000 | $ 2000 | $ 2500 |
| Detailed Review of Customer made 510k in 12 working days | $ 4000 | $ 4500 | $ 5000 |
| (a) US Agent
(b) Pre- Submission (2Nos Max.) (c) Final Submission (d) Stationery & Courier |
$ 2500 | $ 2500 | $ 2500 |
OPTION 1: PACKAGE FEES (Full Option)
| 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 |
⇒ In addition to our standard services, our team of experts is available for on-site technical consultations and explanations for an extra fee of 2-3 man-days. Please note that travel, hotel, and a man-day fee of $400 will be charged in addition to this.
⇒ The prices listed above are subject to change depending on the complexity and variety of models, accessories, designs, and device codes involved in the 510k application.
⇒ Please be aware that FDA Establishment Registration Fees of $6,493 will be payable only after 510k clearance has been granted.
OPTION 2: PARTIAL SERVICE 510K FEES
| Activity | Special 510k | Abbreviated 510k | Traditional 510k |
| Quick Review of Customer made 510k in 3 working days | $ 1500 | $ 2500 | $ 2500 |
| Detailed Review of Customer made 510k in 12 working days | $ 4500 | $ 4500 | $ 5000 |
| (a) US Agent
(b) Pre- Submission (2Nos Max.) (c) Final Submission (d) Stationery & Courier |
$ 2500 | $ 2500 | $ 2500 |
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