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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)

 

USFDA 510k Review Fees: $12745 ( Standard)
USFDA 510k Review Fees: $3186 ( Small Business)
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