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FDA 510k Fees For Medical Devices

In the year 2023, the FDA is expected to grant 1700 or more 510k clearances, with 57% or more coming from overseas 510k applicants. Do you have any questions concerning the 510k Fees? How much do 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

2023 Financial Year (October 1, 2022, through September 30, 2023)

US FDA 510k Review Fees: $19,870 (Standard)
US FDA 510k Review Fees: $4,967 (Small Business)
FDA Establishment Registration Fees: $6,493 

OPTION 1: PACKAGE FEES (Full Option)

 

Activity  Special 510k Abbreviated 510k   Traditional 510k  
Guidance (Offsite)* $ 6000 $ 7000 $ 8000
510k Preparation & Review $ 9000 $ 9000 $ 10000
Pre- Submission (2 Nos) with US Agent, Stationery & Courier $ 1000 $ 1000 $ 1000
TOTAL $ 16000 $ 17000 $ 19000
Payment Terms 40:30:20:10 40:30:20:10 40:30:20:10

Note 01: For an additional fee for 2-3 man-days, our experts are available on-site as needed for technical consultations and explanations. Travel, hotel, and a man-day fee of $400 are charged extra.

Note 02: The above prices might differ depending on the variety of models, accessories, designs, and Device codes.

Note 03: FDA Establishment Registration Fees of $6,493 to be paid after 510k clearance only

 

OPTION 2: PARTIAL SERVICE FEES

 

Activity Special 510k Abbreviated 510k Traditional 510k  
Quick Review of Customer made 510k in 3 working days $ 2500 $ 2500 $ 2500
Detailed Review of Customer made 510k in 12 working days $ 4000 $ 4500 $ 5000
(a) US Agent

(b) Pre- Submission (2Nos Max.)                               

(c) Final Submission

(d) 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 $ 10000 $ 10000 $ 10000
Pre- Submission (2 Nos) with US Agent, Stationery & Courier $ 1000 $ 1000 $ 1000
TOTAL $ 17000 $ 18000 $ 19000
Payment Terms 40:30:20:10 40:30:20:10 40:30:20:10

 

Note 01: For an additional fee for 2-3 man-days, our experts are available on-site as needed for technical consultations and explanations. Travel, hotel, and a man-day fee of $400 are charged extra.

Note 02: The above prices might differ depending on the variety of models, accessories, designs, and Device codes.

Note 03: FDA Establishment Registration Fees of $6,493 to be paid after 510k clearance only

Note 04: 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
(a) US Agent

(b) Pre- Submission (2Nos Max.)                               

(c) Final Submission

(d) 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 $ 11000 $ 11000 $ 11000
Pre- Submission (2 Nos) with US Agent, Stationery & Courier $ 1000 $ 1000 $ 1000
TOTAL $ 18000 $ 19000 $ 21000
Payment Terms 40:30:20:10 40:30:20:10 40:30:20:10

Note 01: For an additional fee for 2-3 man-days, our experts are available on-site as needed for technical consultations and explanations. Travel, hotel, and a man-day fee of $400 are charged extra.

Note 02: The above prices might differ depending on the variety of models, accessories, designs, and Device codes.

Note 03: FDA Establishment Registration Fees of $6,493 to be paid after 510k clearance only

 

OPTION 2: PARTIAL SERVICE FEES

 

Activity Special 510k Abbreviated 510k Traditional 510k  
Quick Review of Customer made 510k in 3 working days $ 2000 $ 2000 $ 2500
Detailed Review of Customer made 510k in 12 working days $ 4000 $ 4500 $ 5000
(a) US Agent

(b) Pre- Submission (2Nos Max.)                               

(c) Final Submission

(d) Stationery & Courier

$ 2500 $ 2500 $ 2500

OPTION 1: PACKAGE FEES (Full Option)

 

Activity Special 510k Abbreviated 510k   Traditional 510k
Guidance (Offsite)* $ 8000 $ 9000 $ 10000
510k Preparation & Review $ 10000 $ 10000 $ 11000
Pre- Submission ( 2 Nos) with US Agent, Stationery & Courier $ 1000 $ 1000 $ 1000
TOTAL $ 19000 $ 20000 $ 22000
Payment Terms 40:30:20:10 40:30:20:10 40:30:20:10

Note 01: For an additional fee for 2-3 man-days, our experts are available on-site as needed for technical consultations and explanations. Travel, hotel, and a man-day fee of $400 are charged extra.

Note 02: The above prices might differ depending on the variety of models, accessories, designs, and Device codes.

Note 03: FDA Establishment Registration Fees of $6,493 to be paid after 510k clearance only

 

OPTION 2: PARTIAL SERVICE 510K FEES

 

Activity  Special 510k    Abbreviated 510k   Traditional 510k  
Quick Review of Customer made 510k in 3 working days $ 1500 $ 2500 $ 2500
Detailed Review of Customer made 510k in 12 working days $ 4500 $ 4500 $ 5000
(a) US Agent

(b) Pre- Submission (2Nos Max.)                               

(c) Final Submission

(d) Stationery & Courier

$ 2500 $ 2500 $ 2500

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