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You want to sell your medical device in the US market? Yes, you need to identify United States FDA Agent for that enterprise. This agent is mainly for the FDA correspondence.

Not sure about whom to appoint as US FDA Agent for your submission and what are the roles & responsibilities of the US FDA Agent and why do you need to appoint an agent? 

Well, Maven has got it covered for you! 

Maven is one of the most efficient and esteemed US FDA agents to oblige for the Non – US based Medical Devices manufacturers. 

Who needs to appoint US FDA Agent?

  • Food Industries 
  • Pharmaceutical Organizations 
  • Medical Device Facilities 
  • Applicants of NDA or IND 
  • Companies intended to submit the controlled correspondence to the FDA 

Responsibilities of the US FDA Agent

A US FDA Agent has to be a resident of the United States or one should have a place of business in the US. The manufacturer can appoint the same US agent as their Office Correspondent, but it is not mandatory. At least one US agent is mandatory to appoint!

Along with the assistance to FDA for communications, response to the questions regarding the sold products & scheduling inspections of your facilities, one might also be provided with the information or your submission documents.

After submitting the electronic copy, the US Agent shall provide the confirmation to complete the process. A Verification mail will be sent to the US Agent to do that. Even his consent would be required. In case of rejection from the US Agent’s side, the same notification will be sent to the manufacturer and the company will have to look for a new Agent for itself!

To handle such paramount responsibilities, it is very essential to appoint a responsible, professional, and reliable agent for your company.

How it is submitted?

By utilizing the “FURLS system – FDA Unified Registration and Listing System”, this information is to be submitted electronically. Also, submitting this information is a part of the registration process. 

What details of the US Agent should be submitted?

Below mentioned details of the US Agent need to be submitted along with the registration documents – 

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