FDA 510k Fees
Are you confused? How much are the FDA 510k fees for getting medical device clearance for sale in the USA?
In the year 2019, the US FDA has given an estimated 2,345 and above 510k clearances and looks like 945 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 below, the FDA 510k fees estimate specifically for each activity till you get the clearance. We will not ditch you halfway! Contact us today.
FDA 510k Budgetary Costing
US FDA 2020 Financial year Fees
Annual FDA Establishment Registration Fees : $5,236Â ( To be paid after 510k clearance only)
ACTIVE DEVICES
OPTION 1: Full Service Fees
| Premarket Notification Type | Abbreviated 510k | Traditional 510k  | Special 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 |
* onsite presence of our consultants available for technical discussion / clarifications, additional we charge for travelling, accommodation and $400 /man-day ( Service limited to maximum 2-3 man-days only)
OPTION 2: Partial Service Fees
| Premarket Notification Type | Abbreviated 510k | Traditional 510k   | Special 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 |
SOFTWARE DEVICES
OPTION 1: Full Service Fees
| Premarket Notification Type | Abbreviated 510k | Traditional 510k  | Special 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 |
* onsite presence of our consultants available for technical discussion / clarifications, additional we charge for travelling, accommodation and $400 /man-day ( Service limited to maximum 2-3 man-days only)
OPTION 2: Partial Service Fees
| Premarket Notification Type | Abbreviated 510k | Traditional 510k    | Special 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 |
NON-ACTIVE DEVICES
OPTION 1: Full Service Fees
| Premarket Notification Type | Abbreviated 510k | Traditional 510k | Special 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 |
* onsite presence of our consultants available for technical discussion / clarifications, additional we charge for travelling, accommodation and $400 /man-day ( Service limited to maximum 2-3 man-days only)
OPTION 2: Partial Service Fees
| Premarket Notification Type | Abbreviated 510k | Traditional 510k | Special 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 |
IMPLANT DEVICES
OPTION 1: Full Service Fees
| Premarket Notification Type | Abbreviated 510k  | Traditional 510k | Special 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 |
* onsite presence of our consultants available for technical discussion / clarifications, additional we charge for travelling, accommodation and $400 /man-day ( Service limited to maximum 2-3 man-days only)
OPTION 2: Partial Service Fees
| Premarket Notification Type | Abbreviated 510k  | Traditional 510k | Special 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 |