US FDA Representative Agent for the Food & Drug Administration
The United States Food and Drug Administration (FDA) requires all medical devices, IVD, and pharmaceutical companies without a US location to appoint a US FDA Registered Agent. A nominated US FDA Agent must be a resident of the United States or maintain a place of business in the US. A trusted company serves as the official FDA Agent for more than 100 medical device, pharmaceutical, and IVD companies from more than 25 countries worldwide. Why do you need an agent in the USA? The FDA does not clarify the reason for this requirement; it simply says that if you are a homeless company in American territory, you must have an agent to represent you. The FDA wants to take away the headache of contacting companies in which the contact person may speak poor English, at a different time than the US, and with unreliable media. These points make the transmission of information can be compromised. If the FDA directly notified exporters in their countries of origin of any problem