FDA Agent is a mandatory requirement for foreign food, drug, and medical device establishments who market their product in the USA. FDA agent is for FDA to communicate with the establishment. FDA contact the US Agent to schedule inspections, if not able to contact the establishments directly.
FDA Agent for Food Facility
US Agent is a required information in section 7 of FDA food facility registration form, without completing this field the registration will not complete. Also, FDA will assign registration number only if the US Agent confirm the FDA Agent assignment. For food facility, US Agent can be a person or a company in the USA. In case of re-inspection required, FDA will send the invoice to the US Agent and US Agent is responsible to pay the fees.
FDA Agent for Drug Establishment
For drug establishment registration, you should provide the name and DUNS number of your US Agent in drug establishment registration SPL. 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 who market medical devices in the USA must have an FDA Agent to complete the FDA registration. During establishment registration process, FDA will send a confirmation e-mail to the FDA Agent and the FDA Agent need confirm the receipt code.
FDA Agent Service Fees
LMG fees for FDA agent service varies with 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 the product quality or custom clearing or FDA detention issues. It is only for FDA communication. US FDA agent is not required to issue prior notice or medical device reporting.
LMG provide US FDA Agent service to foreign food, drug and medical device establishments.