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Expert U.S. Agent services for FDA Communication

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The U.S. Food and Drug Administration (FDA) requires food and beverage, cosmetic, medical device, drug, and radiation-emitting device companies located outside the United States to designate a U.S. Agent when registering with the FDA for communication with the FDA.
Designate FDA Agent Pro as Your U.S. Agent
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, make a wire transfer payment, or for 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.
Experience
As one of the world’s largest FDA registration companies with 1,000+ customers, our expert team will help you register your food, beverage, supplement, medical device, OTC drug, and cosmetic facility for FDA compliance and serve as your US Agent as required for companies outside of the US.
24/7 representation and ongoing communication with FDA on your behalf
Expert agents located in San Diego, California USA

How FDA Agent Pro Can Help

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 there. US FDA agents cannot use a P.O. Box as an address. A US FDA agent or an employee must be available to answer the phone 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 Registration- Issue Prior Notice to the US FDA- Compliant 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 Establishment- Responding to questions concerning the foreign establishment's devices that are imported or offered for import into the US- Assisting the FDA in scheduling inspections of the foreign establishment- If 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 Registration- Medical Device Listing- FDA 510 K Submission- Official Correspondent Requirements- Complying 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 FDA- Drug Listing with the US FDA- Obtaining Labeler Code from the US FDA- Compliant Drug Label Review US FDA Agent Service to Cosmetic Manufacturers / MoCRA Establishments
A US FDA agent is mandatory for foreign cosmetic establishments. A US FDA agent can help you with cosmetic establishment registration and FDA product listing.
As your US FDA Agent, FDA Agent Pro can assist you with:
- Cosmetics Establishment Registration- Cosmetic Product Listing- Cosmetic Label Review for FDA Compliance
US Agent Terms and Conditions and Scope of Services