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510(k) Consulting and FDA Review Fees [FY 2019]

 

The service available from Chicago, Bremen and Bangalore.

US FDA Medical Device Establishment Registration Annual Fee (FY 2019)      -     4884 USD
US FDA 510k Review Fee (FY 2019)    -     10953 USD
above payments to be send directly to US FDA on annual basis by clients

 

(Option 1) US FDA 510k Guidance & Technical Documentation (complete package) Fees

Payable to I 3 CONSULTING [Oct 2018 - Sep 2019]

Type of Device

Guidance Fee

510k (File) preparation

Submission Fee

Non-invasive

7500 – 8500 USD

5000 – 6000 USD

500 USD

Invasive

9500 – 10500 USD

6000 - 7000 USD

500 USD

Implant

11000 - 12500 USD

6500 - 7500 USD

500 USD

 

(Option 2) FDA 510k Partial Service Fees (Optional)

Payable to I 3 CONSULTING [Oct 2018 - Sep 2019]   

Activity

Fees / Cost

Remarks

USFDA 510k detailed Review

5500 - 7500 USD /510k

Device Code, Regulation Number & Predicate device accurate information must be provided by the client.

Timeline 30 working days

USFDA 510k Quick Review +

FDA Pre-Submission *

5000-6500 USD/510k

Expected timeline 90 to 120 days.

US Agent Fees, File Conversion & Stationery / Courier charges included

( No payment needed for FDA)

* 510k submission can be added to above service with addition fees of 1500 USD

USFDA 510k Pre-Submission

2500 USD /510k

US Agent Fees, File Conversion & Stationery / Courier charges included

Expected timeline 90 days.

( No payment needed for FDA)

USFDA 510k Pre-Submission + FDA 510k Submission

5500 USD / 510k

Expected Pre-Submission timeline 90 days

Expected 510(k) Review timeline 120 days

FDA Pre-Submission is free and 510k Submission FY review charges applicable

US Agent Fees, File Conversion & Stationery / Courier charges included

  • Country specific Government taxes additional.
  • We provide Consultant onsite visit based on customer request. Travelling and Boarding as per actual invoiced.
  • Clients are requested to fill the QRF. The official quote for US FDA 510(k) will be prepared on receipt of filled QRF only.
  • Project cost divided into 4 installements based on the progress of project.
  • Method of communication - Email / Telephone / Skype / Whatsapp.
  • Language for communication – English.
  • Complete documention by Cloud server.
  • 510k prepration, Pre-submission till Final Submission expected timeline is 140 days. Additional 120 to 180 days expected for 510(k)clearance.

Please Fill the Request For Quote (RFQ) here:
We will send the official proposal with agreement upon receipt of filled RFQ.

Payment Methods will be send along with the proposal/agreement.

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INDIA – Bangalore
+ 91 994 591 2081
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USA – Chicago
+1 630 696 1293
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GERMANY – Bremen
+49 2161 990 8831
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mail enquiry@i3cglobal.com
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