FDA 510k Fees
Are you confused about the FDA 510k Fees for medical devices?
What is the cost for a 510(k) medical device submission charged by the FDA and Consultants?
In the year 2020, the US FDA has given an estimated 1,430 and above 510(k) clearances which looks like 445 and above are from foreign manufacturers. We have clients who have come back to us abandoning the existing agreement with multiple vendors. The main reason was the pricing and additional billing for closing/answering FDA queries. The majority of them spent $30,000 – $50,000 with other consulting companies only for guidance and review.
Check out our pricing estimate of the FDA 510k Fees for each activity till you get the clearance. We will not ditch you halfway!
FDA 510k Budgetary Costing
2022 Financial Year (October 1, 2021, through September 30, 2022)
FDA Establishment Registration Fees: $5672 ( To be paid after 510k clearance only)
OPTION 1: PACKAGE FEES (Full Option)
| Activity | Special 510k | Abbreviated 510k | Traditional 510k |
| Guidance (Offsite)* | $ 6000 | $ 7000 | $ 8000 |
| 510k Preparation & Review | $ 6000 | $ 6500 | $ 7000 |
| Pre- Submission ( 2 Nos) with US Agent, Stationery & Courier | $ 1000 | $ 1000 | $ 1000 |
| TOTAL | $ 13000 | $ 14500 | $ 16000 |
| Payment Terms | 40:10:20:20:10 | 40:10:20:20:10 | 40:10:20:20:10 |
(a) * As needed, our specialists come on-site for technical consultations and explanations. The customer is responsible for travel, lodging, and $400 per man-day ( Service limited to a maximum of 2-3 man-days)
(b) Fees are subject to fluctuate depending on the number of variants/models and Device code.
(c) 510k Submission Process Chart with responsibilities of Consultants and Manufactures.
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 |
| US Agent Pre- Submission (2) Final Submission 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 | $ 6000 | $ 6500 | $ 7000 |
| Pre- Submission ( 2 Nos) with US Agent, Stationery & Courier | $ 1000 | $ 1000 | $ 1000 |
| TOTAL | $ 13000 | $ 14500 | $ 16000 |
| Payment Terms | 40:10:20:20:10 | 40:10:20:20:10 | 40:10:20:20:10 |
(a) * As needed, our specialists come on-site for technical consultations and explanations. The customer is responsible for travel, lodging, and $400 per man-day ( Service limited to a maximum of 2-3 man-days)
(b) Fees are subject to fluctuate depending on the number of variants/models and Device code.
(c) 510k Submission Process Chart with responsibilities of Consultants and Manufactures.
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 |
| US Agent Pre- Submission (2) Final Submission 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 | $ 8000 | $ 9000 | $ 10000 |
| Pre- Submission ( 2 Nos) with US Agent, Stationery & Courier | $ 1000 | $ 1000 | $ 1000 |
| TOTAL | $ 15000 | $ 17000 | $ 19000 |
| Payment Terms | 40:10:20:20:10 | 40:10:20:20:10 | 40:10:20:20:10 |
(a) * As needed, our specialists come on-site for technical consultations and explanations. The customer is responsible for travel, lodging, and $400 per man-day ( Service limited to a maximum of 2-3 man-days)
(b) Fees are subject to fluctuate depending on the number of variants/models and Device code.
(c) 510k Submission Process Chart with responsibilities of Consultants and Manufactures.
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 |
| US Agent Pre- Submission (2) Final Submission Stationery Courier |
$ 1000 | $ 1000 | $ 1000 |
OPTION 1: PACKAGE FEES (Full Option)
| Activity | Special 510k | Abbreviated 510k | Traditional 510k |
| Guidance (Offsite)* | $ 8000 | $ 9000 | $ 10000 |
| 510k Preparation & Review | $ 8000 | $ 9000 | $ 9000 |
| Pre- Submission ( 2 Nos) with US Agent, Stationery & Courier | $ 1000 | $ 1000 | $ 1000 |
| TOTAL | $ 17000 | $ 19000 | $ 20000 |
| Payment Terms | 40:10:20:20:10 | 40:10:20:20:10 | 40:10:20:20:10 |
(a) * As needed, our specialists come on-site for technical consultations and explanations. The customer is responsible for travel, lodging, and $400 per man-day ( Service limited to a maximum of 2-3 man-days)
(b) Fees are subject to fluctuate depending on the number of variants/models and Device code.
(c) 510k Submission Process Chart with responsibilities of Consultants and Manufactures.
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 |
| US Agent Pre- Submission (2) Final Submission Stationery & Courier |
$ 2000 | $ 2000 | $ 2000 |
Surgical Gowns, Examination Gloves, N95, Surgical Face Mask