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US FDA 510(k) FEE

 

The service available from Chicago, USA and Bangalore, India.

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

 

US FDA 510k Scientific, Technical and Documentation Fees payable to I 3 CONSULTING [Oct 2018 - Sep 2019]

Type of Device

Guidance Fee

Preparation of 510(k) Notification

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

 

US FDA Associated Fee towards I 3 Consulting [Oct 2017- Sep 2018]   

Activity

FEE

Annual Charges

Label Review

649 USD /Device

NA

Establishment Registration

449 USD

449 USD

Device Listing

50 USD /Device

NA

US Agent Fee

649 USD / Category

649 USD

  • Country specific Government taxes additional.
  • Site visit will be customer discretion. Travelling and Boarding as per actual invoiced.
  • Clients are requested to fill the QRF. The official quote for US FDA 510k will be prepared send after studying the complexities of the device in question and predicate device.
  • Project cost divided into 4 installements based on the progress of project.
  • Method of communication - Telephone / Skype / G talk.
  • Language for communication – English.
  • Complete documention by Cloud server.
  • Minimum Timeline - 90 Days for Submission file preparation

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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