FDA 510k Fees For Medical Devices
In the year 2023, the FDA is expected to grant 1700 or more 510k clearances, with 57% or more coming from overseas 510k applicants. Do you have any questions concerning the 510k Fees? How much do the review and consultants charges?
Many 510k applicants have returned to us after terminating their current agreements with other consultants. The 510k file preparation and extra charging for answering FDA enquiries were the key reasons for the.
Estimate for 510k Submission Cost
2023 Financial Year (October 1, 2022, through September 30, 2023)
FDA Establishment Registration Fees: $6,493
OPTION 1: 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 |
Note 01: For an additional fee for 2-3 man-days, our experts are available on-site as needed for technical consultations and explanations. Travel, hotel, and a man-day fee of $400 are charged extra.
Note 02: The above prices might differ depending on the variety of models, accessories, designs, and Device codes.
Note 03: FDA Establishment Registration Fees of $6,493 to be paid after 510k clearance only
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 |
Note 01: For an additional fee for 2-3 man-days, our experts are available on-site as needed for technical consultations and explanations. Travel, hotel, and a man-day fee of $400 are charged extra.
Note 02: The above prices might differ depending on the variety of models, accessories, designs, and Device codes.
Note 03: FDA Establishment Registration Fees of $6,493 to be paid after 510k clearance only
Note 04: IEC 62304 Implementation and guidance are not included in the above pricing. Service provided on extra 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 |
Note 01: For an additional fee for 2-3 man-days, our experts are available on-site as needed for technical consultations and explanations. Travel, hotel, and a man-day fee of $400 are charged extra.
Note 02: The above prices might differ depending on the variety of models, accessories, designs, and Device codes.
Note 03: FDA Establishment Registration Fees of $6,493 to be paid after 510k clearance only
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 |
Note 01: For an additional fee for 2-3 man-days, our experts are available on-site as needed for technical consultations and explanations. Travel, hotel, and a man-day fee of $400 are charged extra.
Note 02: The above prices might differ depending on the variety of models, accessories, designs, and Device codes.
Note 03: FDA Establishment Registration Fees of $6,493 to be paid after 510k clearance only
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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