FDA Agent is a mandatory requirement for foreign food, drug, and medical device establishments that market their product in the USA. FDA agent is for FDA to communicate with the establishment. FDA contacts the US Agent to schedule inspections if not able to get to the establishments directly.
FDA Agent for Food Facility
US Agent is required information in section 7 of the FDA food facility registration form; without completing this field, the registration will not be complete. Also, FDA will assign a registration number only if the US Agent confirms the FDA Agent assignment. For food facilities, US Agent can be a person or a company in the USA. If re-inspection is required, the FDA will send the invoice to the US Agent, and US Agent is responsible for paying the fees.
FDA Agent for Drug Establishment
You should provide your US Agent’s name and DUNS number in the drug establishment registration SPL for drug establishment registration. Since FDA is requesting the DUNS number, the US Agent must be a company in the USA having a DUNS Number.
FDA Agent for Medical Device Establishment
Foreign medical device establishments that market medical devices in the USA must have an FDA Agent to complete the FDA registration. The FDA will send a confirmation e-mail to the FDA Agent during the establishment registration process, and the FDA Agent needs to confirm the receipt code.
FDA Agent Service Fees
LMG fees for FDA agent service varies with the type of registration; you can find FDA registration and US Agent service fee at FDA Agent Fees
FDA Agent Responsibilities
US FDA Agent is not responsible for product quality, custom clearing, or FDA detention issues. It is only for FDA communication. US FDA agent is not required to issue a prior notice or medical device reporting.
LMG provides US FDA Agent service to foreign food, drug, and medical device establishments.