US FDA 510(k) FEE

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

US FDA Establishment Fee FY 2017      -     3382 USD
US FDA 510k Review Fee [Oct 2016- Sep 2017]    -     4690 USD
All payments to be send directly to US FDA

 

US FDA 510k Scientific, Technical and Documentation Fee towards
I 3 Consulting [Oct 2016 - Sep 2017]

Type of Device

Guidance Fee

Preparation of 510(K) Notification

Submission Fee

Non-invasive

6500 – 7000 USD

4000 – 4500 USD

500 USD

Invasive

8500 – 9000 USD

5000 - 5500 USD

500 USD

Implant

10000 - 11000USD

5500 - 6500 USD

500 USD

 

US FDA Associated Fee towards I 3 Consulting [Oct 2016- Sep 2017]   

Activity

FEE

Annual Charges

Label Review

649 USD /Device

NA

Establishment Registration

349 USD

NA

Device Listing

50 USD /Device

NA

US Agent Fee

649 USD / Category

649 USD

  • Payments accepted in Indian rupees or in US Dollars. Govt. 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 can be send only after studying the complexities of the device.
  • Fee to be paid in 4 equal Instalments.
  • 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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mail enquiry@i3cglobal.com

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