The responsibilities of the U.S. agent are limited and include: Professionals focus on a core business and use other professionals to manage related functions. If you are a broker, use a forwarder; If you are an importer, use a customs broker. Similarly, using a professional company as an agent of the U.S. FDA, an agent who is responsible for serving as a necessary communication liaison between your customers and members and the U.S. Food and Drug Administration, helps ensure full compliance with the new rules. Maybe you have a niche market or try to use a niche market for your products. You cannot take the risk that a disclosure, even accidental, or your trade secrets and confidential information will be made to your detriment by an agent you have chosen and who is in the same area as you. The FDA may also provide information or documents to your U.S. agent, which is considered equivalent to making your business available.

That`s why it`s important to appoint a professional and reliable regulatory company that represents your interests. Email us to and describe your activity (manufacturer, labeler, testing lab, etc.) and describe your medications (OTC, sunscreen, disinfectant, etc.). We can then provide you with more detailed information about the process. The new term and the requirement of a “U.S. agent” is very specific in the new rules and does not apply to agents that you may already have for customs or other purposes. It is a new term for a person or company with very different responsibilities and responsibilities. This is the FDA`s contact in the event of an emergency or a potential terrorist threat. Pragmatic acts as a U.S. agent for companies to facilitate communication between the U.S. Food and Drug Administration (FDA) and is only responsible for transmitting information received from the FDA to the company, unless there is a specific service agreement.

We list all your exempt and 510 (k)-cleared devices that are included in our flat fee. Our fees include registration, classification of your devices, U.S. Agent Service, changes whenever necessary and a certificate of courtesy of FDA registration. We complete the registration and list within three business days. If you have any questions, email us to