U.S. Agent Appointment Form
Our annual fee for U.S. Agent services is just $299. By committing to a two-year plan, you can enjoy a reduced rate of $269 per year.
To submit information offline, wire transfer payments, or any other inquiries, please contact us at info@fdaagentpro.com. Once you complete the online form and submit your payment, we will confirm receipt and provide the U.S. Agent details. An invoice will be issued following payment confirmation.
To submit information offline, wire transfer payments, or any other inquiries, please contact us at info@fdaagentpro.com. Once you complete the online form and submit your payment, we will confirm receipt and provide the U.S. Agent details. An invoice will be issued following payment confirmation.
The U.S. Food and Drug Administration (FDA) requires food and beverage, cosmetic, medical device, drug, and radiation-emitting device companies located outside of the United States to designate a U.S. Agent when registering with the FDA for FDA communication. (21 CFR § 207.69(b))
US FDA Agent Service to Foreign Food Facilities
A US FDA Agent is required for foreign food facilities that manufacture, process, pack, or hold food for human or animal consumption in the U.S. The US FDA agent must either reside in the USA or maintain a place of business in the USA. US FDA agents cannot use a post office box as an address. A US FDA agent must be available to answer the phone, or an employee must be available to answer it, during regular business hours. The FDA agent acts as a communications link between the US FDA and the food facility for both routine and emergency communications unless the facility designates a different emergency contact. Please visit our fee page for the updated fee schedule at FDA Registration Fees
As your FDA Food Agent, FDA Agent Pro can assist you with:
Food Facility RegistrationIssue Prior Notice to the US FDACompliant Food Product Labeling with FDA Requirements US FDA Agent to Medical Device Establishments
Any foreign medical device establishment engaged in the manufacture, preparation, propagation, compounding, or processing of a medical device imported into the United States must identify a U.S. FDA agent for that establishment. Information about a foreign establishment's US FDA agent is submitted electronically using the FURLS system and is part of the establishment registration process. Each foreign establishment may designate only one FDA agent. The foreign establishment may also designate its US FDA agent as its official correspondent. The US FDA agent is not responsible for reporting adverse events under the Medical Device Reporting regulation. Please visit our fee page for the updated fee schedule at FDA Registration Fees
The responsibilities of the US FDA Agent are limited and include:
Assisting the FDA in Communications With the Foreign EstablishmentResponding to questions concerning the foreign establishment's devices that are imported or offered for import into the USAssisting the FDA in scheduling inspections of the foreign establishmentIf the FDA is unable to contact the foreign establishment directly, the FDA may provide information or documents to the US FDA agent As your U.S. FDA Agent, FDA Agent Pro can assist you with:
Medical Device Establishment RegistrationMedical Device ListingFDA 510 K SubmissionOfficial Correspondent RequirementsComplying with Medical Device Labeling with FDA Regulations US FDA Agent for Drug Establishments
Foreign establishments that manufacture, repack, or re-label drug products and import or offer for import drug products to the United States must register with the FDA and identify a U.S. FDA agent. All drugs imported into the United States must be listed by the foreign firm or its designated US FDA agent. Please visit our fee page for the updated fee schedule at FDA Registration Fees
As your US FDA Agent, FDA Agent Pro can assist you with:
Drug Establishment Registration with the US FDADrug Listing with the US FDAObtaining Labeler Code from the US FDACompliant Drug Label Review US FDA Agent Service to Cosmetic Manufacturers
A US FDA agent is mandatory for foreign cosmetic establishments. A US FDA agent can help you with cosmetic establishment registration and product listing with the FDA.
As your US FDA Agent, FDA Agent Pro can assist you with:
Cosmetics Establishment RegistrationCosmetic Product ListingCosmetic Label Review for FDA Compliance
A US FDA Agent is required for foreign food facilities that manufacture, process, pack, or hold food for human or animal consumption in the U.S. The US FDA agent must either reside in the USA or maintain a place of business in the USA. US FDA agents cannot use a post office box as an address. A US FDA agent must be available to answer the phone, or an employee must be available to answer it, during regular business hours. The FDA agent acts as a communications link between the US FDA and the food facility for both routine and emergency communications unless the facility designates a different emergency contact. Please visit our fee page for the updated fee schedule at FDA Registration Fees
As your FDA Food Agent, FDA Agent Pro can assist you with:
Food Facility RegistrationIssue Prior Notice to the US FDACompliant Food Product Labeling with FDA Requirements US FDA Agent to Medical Device Establishments
Any foreign medical device establishment engaged in the manufacture, preparation, propagation, compounding, or processing of a medical device imported into the United States must identify a U.S. FDA agent for that establishment. Information about a foreign establishment's US FDA agent is submitted electronically using the FURLS system and is part of the establishment registration process. Each foreign establishment may designate only one FDA agent. The foreign establishment may also designate its US FDA agent as its official correspondent. The US FDA agent is not responsible for reporting adverse events under the Medical Device Reporting regulation. Please visit our fee page for the updated fee schedule at FDA Registration Fees
The responsibilities of the US FDA Agent are limited and include:
Assisting the FDA in Communications With the Foreign EstablishmentResponding to questions concerning the foreign establishment's devices that are imported or offered for import into the USAssisting the FDA in scheduling inspections of the foreign establishmentIf the FDA is unable to contact the foreign establishment directly, the FDA may provide information or documents to the US FDA agent As your U.S. FDA Agent, FDA Agent Pro can assist you with:
Medical Device Establishment RegistrationMedical Device ListingFDA 510 K SubmissionOfficial Correspondent RequirementsComplying with Medical Device Labeling with FDA Regulations US FDA Agent for Drug Establishments
Foreign establishments that manufacture, repack, or re-label drug products and import or offer for import drug products to the United States must register with the FDA and identify a U.S. FDA agent. All drugs imported into the United States must be listed by the foreign firm or its designated US FDA agent. Please visit our fee page for the updated fee schedule at FDA Registration Fees
As your US FDA Agent, FDA Agent Pro can assist you with:
Drug Establishment Registration with the US FDADrug Listing with the US FDAObtaining Labeler Code from the US FDACompliant Drug Label Review US FDA Agent Service to Cosmetic Manufacturers
A US FDA agent is mandatory for foreign cosmetic establishments. A US FDA agent can help you with cosmetic establishment registration and product listing with the FDA.
As your US FDA Agent, FDA Agent Pro can assist you with:
Cosmetics Establishment RegistrationCosmetic Product ListingCosmetic Label Review for FDA Compliance