US-Agent

This article provides a clear overview of the services offered by BEO BERLIN as a US agent and shows the process of FDA registration and product listing, support with pre-market notification and the advantages of partnering with BEO BERLIN.

The services of BEO BERLIN as a US agent

• Registering the company and listing products: BEO BERLIN supports clients in setting up a user account with the FDA and registers the company and lists the products in the FDA database.

• Maintaining and renewing the listing: Renewing and maintaining the listing every year is an important part of maintaining the validity of the registration. BEO BERLIN takes care of these tasks and ensures that the FDA always has up-to-date information.

• Communication with the FDA: As the sole point of contact for the FDA, BEO BERLIN takes over all communication, informs its customers transparently about necessary activities and ensures that all processes run smoothly.
  
  
  

US agent registration process with BEO BERLIN

The process of registering and listing medical devices with the FDA requires a clear and structured approach. BEO BERLIN offers its customers comprehensive support every step of the way or takes over this process to a large extent, working with its customers to ensure that all regulatory requirements are met.

The individual steps in the registration process are

1. Initial document review: To begin with, BEO BERLIN conducts a comprehensive preliminary review of the product’s conformity with the FDA requirements. This step includes:
   
   
   
   • Clarification of whether a PMN procedure (Premarket Notification / 510(k)) is necessary to be able to list a product.
     
     
   • Compiling the required documents such as product descriptions, labelling and test reports.
     
     
   • Provision of templates for manufacturer declarations and assessment of the submitted documents for completeness.
     
     
2. Opening an FDA account and registration: Once the verification has been successfully completed, BEO BERLIN sets up an FDA-FURLS account for the company. This is followed either by the PMN procedure or by the company’s registration and the listing of the first products.
   
   
3. Annual maintenance and renewal: Registration must be renewed and the information updated annually to maintain registration. BEO BERLIN takes care of these tasks and ensures that the listed products always comply with current FDA requirements.

Pre-market notification (PMN/510(k)) – application submitted by BEO BERLIN

In addition to the basic registration and listing tasks, BEO BERLIN offers additional support in the area of pre-market notification (PMN) and 510(k) submissions. These services are specifically designed for devices that require advanced documentation and regulatory review.

These services include

• Compiling the PMN documentation: BEO BERLIN selects the documents provided by the manufacturer and formats them for the PMN application. We provide the necessary manufacturer declarations and, if necessary, suggestions for ‘improving’ the documents.
  
  

• Subsequent document review and action plan: If additional or amended documents are required, BEO BERLIN reviews and assesses the documents submitted. This includes the creation of an action plan and advice on how to optimise the documentation.
  
  

• Submission of final documents: Once all the preparatory steps have been completed, BEO BERLIN ensures that all final documents are submitted and that the approval procedure starts smoothly. We respond to any queries from the FDA immediately and in a professional manner, in consultation with you.
  
  
  

Overview of costs and information for customers

To ensure transparent co-operation, BEO BERLIN provides important information on the fees incurred and the scope of its services:

• FDA fees: The official FDA fees, such as the annual registration fee or the PMN user fee, are not included in the BEO BERLIN offer and can be paid directly to the FDA by the client. This avoids costly intermediate steps and ensures maximum cost transparency. If a small-business cost reduction is possible, we will provide appropriate information and help with the necessary assertion.
  
  

• Disclaimer: The responsibility of the US Agent is limited to communication with the FDA and assistance with FDA compliance. BEO BERLIN does not provide legal advice and does not accept any responsibility for adverse event reporting or 510(k) Premarket Notifications submission.
  
  
  

• Responsibilities of the client: BEO BERLIN proactively informs its customers about upcoming activities such as fee payments and registration updates. However, the actual payment and some decisions about necessary adjustments are the responsibility of the client.
  
  
  

Conclusion – Comprehensive support from BEO BERLIN for successful entry to the US market

With BEO BERLIN as their US agent, companies from all over the world have a strong partner that provides expert support throughout every step of the FDA registration process and ensures that all FDA requirements are met. From the initial registration process to product listing and annual renewal, BEO BERLIN offers a reliable solution for meeting the complex requirements of the US market.

Thanks to its experience, clear communication and comprehensive services, BEO BERLIN is the ideal choice for companies looking for a secure, transparent and efficient way to offer their medical devices in the USA.