US FDA Representative Agent for the Food & Drug Administration

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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 with their merchandise and the need to resolve it within a certain period of time, these exporting companies could argue that they did not understand the notification, or that it did not arrive on time, if you face possible future sanctions or prohibitions to the introduction of your products in the US the communication of the information to an American agent exempts the FDA from any responsibility regarding the notification of the information, the agent being responsible for the principal’s knowledge of the nature of said notification and the possible forms of action.

Who can be an agent to the FDA?

The FDA does not establish any criteria or requirements to be an CE Mark Consultant, so anyone can exercise this activity. That is, if your cousin lives in the USA, and is willing to receive notifications on your behalf 24 hours a day, 365 days a year, you can designate him as your agent in American territory. But what if you don’t have a cousin in the USA, how do you look for a commercial agent? For this, you can have several options, but you must bear in mind that none of them will be free since you will be asking a person to be available at all times on your behalf. Among the options you have, can be:

The distributor of your products can also be designated as a commercial agent.
The person in charge of selling your products in the USA can also act as an agent that represents you before the FDA. This option can be very valid if you have signed exclusive contracts with that person. You can negotiate under the conditions of sale of the product that it is he who exercises this role, or, compensate him for exercising it.

Reference link: - https://bit.ly/353ET6V

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