US FDA Agents for the Food & Drug Administration (FDA)
The United States Food and Drug Administration (FDA) requires all medical device, IVD and pharmaceutical companies with no locations in the United States to appoint a registered US FDA Agent. An appointed US FDA Agent must be a resident of the United States OR maintain a place of business in the US. Emergo Group serves as an official FDA Agent for more than 100 medical device companies in more than 25 countries worldwide.
Why you should appoint Emergo Group as your FDA US Agent
- We act as a liaison between your company and the FDA, responding to questions concerning your products, assisting you and the FDA to schedule inspections and helping you resolve problems or delays.
- We ensure that all regulatory responsibilities and interests of our clients are handled professionally, confidentially and promptly.
- We are a stable, well known FDA US Agent representative in the industry and have been in business since 1997.
- Emergo Group is an independent “third party” that will always look after your interests. Manufacturers who appoint a distributor to act as their FDA US Agent can experience problems in this regard.
- Very reasonable yearly fee for US Agent representation.
- We maintain an office in Europe and China for the convenience of our clients.
Should you appoint a distributor to act as your FDA US Agent?
The FDA will allow you to appoint a distributor as your US Agent. However, you should consider the following first:
- As your FDA Agent, will a distributor understand how to properly deal with the FDA if an inquiry or inspection is ordered?
- Distributors come and go. If you choose to list a distributor as your FDA US Agent, what happens if the distributor stops selling your products or goes out of business?
- Will other distributors representing your products in the US be resentful that you have listed one of their competitors in the FDA online database as your official FDA US Agent?
Ask us for a free quote on US FDA Agent representation today.
* Please note that we do not provide US Agent representation for food companies.
