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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)

US FDA 510k Review Fees: $12745 (Standard)
US FDA 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 40:30:20:10 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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