FDA 510k Fees For Medical Devices
In the year 2022, the FDA is expected to grant 1430 or more 510k clearances, with 50% or more coming from overseas 510k applicants. Do you have any questions concerning the 510k Fees? How much does 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
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 | 40:30:20:10 | 40:30:20:10 | 40:30:20:10 |
Note 1: As needed, our specialists come on-site for technical consultations and explanations for an extra cost for 2-3 man-days. (Travel, lodging, and $400 man-day).
Note 2: Above costs are subject to change based on the number of variants, models, accessories, design, and Device code.
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 | 40:30:20:10 | 40:30:20:10 | 40:30:20:10 |
Note 1: As needed, our specialists come on-site for technical consultations and explanations for an extra cost for 2-3 man-days. (Travel, lodging, and $400 man-day).
Note 2: Above costs are subject to change based on the number of variants, models, accessories, design, and Device code.
Note 3: 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 |
| 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 | 40:30:20:10 | 40:30:20:10 | 40:30:20:10 |
Note 1: As needed, our specialists come on-site for technical consultations and explanations for an extra cost for 2-3 man-days. (Travel, lodging, and $400 man-day).
Note 2: Above costs are subject to change based on the number of variants, models, accessories, design, and Device code.
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 | 40:30:20:10 | 40:30:20:10 | 40:30:20:10 |
Note 1: As needed, our specialists come on-site for technical consultations and explanations for an extra cost for 2-3 man-days. (Travel, lodging, and $400 man-day).
Note 2: Above costs are subject to change based on the number of variants, models, accessories, design, and Device code.
OPTION 2: PARTIAL SERVICE 510K 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 |
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