Medical   -   US FDA

WHY US FDA?

Any non US manufacturer of medical devices who wants to place his device in US market isrequired to register his facility and to list his products with US Food and drug administration before exporting to US.

Before registration and listing his product he must obtain 510 K clearances for his devices (if applicable).

ROUTE OF PLACING MEDICAL DEVICE IN US MARKET

The applicant may market the device only after :

a)      Appoint a US Agent.

b)      Obtaining a 510(k) approval (if applicable)

c)      Registration and listing the device with FDA

After successful Registration & listing, you have to comply with FDA regulation (as applicable) as your   facility shall be subjected to FDA compliance inspection at any time.

WHAT IS 510 (k) ?

  • A 510(k) is a premarket compliance made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device.
  • Each person who wants to market in U.S., a medical device (Class I, II, and III device, depending on the level of risk they pose to patients and users.) , for which a Premarket Approval (PMA) is not needed, must subject a 510(k) to FDA unless the device is exempt from 510(k) requirements.
  • There is no 510(k) form; however, 21 CFR 807 Sub part E describes requirements for a 510(k) submission.
  • All 510(k) applications must be proposed to the FDA at most 90 days prior to development in US.

 WHEN A 510(K) IS REQUIRED

  • Introducing a device into marketing, for the first time.
  • When suggesting a different intended use for a device which you not yet have in commercial distribution. 
  • There is a modification or change of a legally marketed device and that change could importantly affect its safety or effectiveness. 
  • If your devices  does not fall in class I and class II 510 K exempt devices.

US Agent

  • If your firm has no local presence in the US market, you must appoint Eurotech as a US Agent as your in-country representative

The US Representative shall either be a US resident or keep a spot of business organization in US.

WHY EUROTECH ?

  • Eurotech assists Medical device manufacturers worldwide to get FDA 510 (K) approval.
  • Our experienced consultants provide guidance for the following FDA 510 k requirements:

 

✔   Identification of Device class, Product Code and Regulation number

✔   Identification of the Predicate device

✔   Guidance in Preparation and Submission of 510 K documents to FDA

✔   Provide US agent service for 510 K (optional)

✔   Communicate to FDA on behalf of client

✔   Aid in Establishment registration with FDA

✔   Assistance in Device listing with FDA

✔   Help you and the FDA in setting up reviews of your overseas establishment.

HOW TO PROCEED  FOR  US FDA

  • Just Send us your contact details, equipment brochures, IFU ,etc at info@eurotechworld.net
  • Appoint Eurotech as your US agent.
  • Pay Fee as applicable below .

 FEES

  • FDA charges fees for Medical device Premarket notification 510 (K) review and Facility registration (annually).
  • This fees is additional to the fees charged by EUROTECH.
  • For FY 2014 (October 1, 2013 through September 30, 2014), US FDA fees for 510(k) review are:

* Standard Fees           :   5,170 USD

              Small Business Fee   :   2,585 USD

  • For FY 2014 (October 1, 2013 through September 30, 2014), US FDA fees for annual registration and listing  is:

*FY 2014(from Oct 2013 to September 2014): 3,313 USD

Note: Fee charged by US FDA is subjected to change each financial year.

 

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