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FDA 510k Fees

Are you confused about the cost of launching medical device in USA?  What is the fee charged by FDA and Consultants for a 510(k) submission of Medical Device? 

In the year 2019, the USFDA has given as an estimated of 2,345 and above 510k clearances which 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 estimate of FDA 510(k) fee 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
USFDA 510k Review Fees : $11,594 ( Standard)
USFDA 510k Review Fees : $2,899 ( Small Business)
Annual FDA Establishment Registration Fees : $5,236  ( To be paid after 510k clearance only)

ACTIVE DEVICES

 

OPTION 1: Full Service Fees

 

Premarket Notification Type Abbreviated 510kTraditional 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 Terms40:10:20:20:1040:10:20:20:1040:10:20:20:10

* 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 510kTraditional 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 510kTraditional 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 Terms40:10:20:20:1040:10:20:20:1040:10:20:20:10

* 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 510kTraditional 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 510kTraditional 510kSpecial 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 Terms40:10:20:20:1040:10:20:20:1040:10:20:20:10

* 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 510kTraditional 510kSpecial 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 510kSpecial 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 Terms40:10:20:20:1040:10:20:20:1040:10:20:20:10

* 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 510kSpecial 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

Special Fees and fast processing of PPE Devices 510k's

Surgical Gowns, Examination Gloves, N95, Surgical Face Mask