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FDA US Registration Agent

FDA Agents

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U.S. Agent and Registration of Facilities Worldwide
for the United States Food and Drug Administration
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Frequently Asked Questions
FDA US Agent and Registration FAQ

 

What is the US FDA registration requirement for food, beverage, dietary supplement, medical or drug companies?

All foreign and domestic Food, Beverage, Dietary Supplement, Medical Device or Drug companies whose products are marketed in the USA must have their company registered, their products listed and all foreign companies must have a designated US Agent [FDA Agents]. If this is not done, the shipments will be denied entry into the USA and domestic and foreign companies are subject to criminal and civil penalties.


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Can I still register even though it is not the beginning of the year?

Yes. You are still required to register if the law applies to your facility or products before your products enter the USA marketplace. In fact, without your very own US FDA Registration, your products will not be allowed entry into the USA and make you liable for civil and criminal liability.

All domestic facilities are also required to register. Failure to register is a prohibited act under the law and subjects the domestic facility to prosecution and civil penalties. Domestic facilities importing any such products must be registered or the shipment will be denied entry, even if the foreign company is already registered.


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What kind of company has to comply with this registration requirement for a food, medical or drug company?

Food/Beverages/Dietary Supplements: Every owner, operator or person in charge of a facility that manufactures, processes, packs or holds food or beverages for human or animal consumption in the United States must register that facility with the United States government's Food and Drug Administration ("FDA") and list the products. Foreign manufacturers must also designate a U.S. Agent.

Medical Devices: Any company (both domestic and foreign), including initial distributors (importers), involved in putting medical devices in the USA commercial marketplace must register their establishments with the FDA and must list their devices and manufacturers (if you are not the manufacturer). In addition to registration, foreign establishments must also designate a U.S. Agent [FDA Agents].

Drugs:Domestic and foreign establishments that manufacture, repack, or re-label drug products in the United States are required to register with the FDA. Domestic and foreign drug manufacturers, repackers or re-labelers are also required to list all of their commercially marketed drug products. Foreign establishments must also designate a U.S. Agent [FDA Agents].


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What happens if I do not register as required?

If you do not register and appoint a US Agent as required by the government of the United States, your shipment will not be allowed into the United States.

Your product will be held at the port of entry, and you will be fully responsible for arranging and paying for all storage, transportation and posting of bond.

If you do not register and appoint a U.S. FDA Agent as required by the government of the United States, you will have committed a prohibited act. The federal government can bring criminal actions in federal court to prosecute, and the federal government can prevent you from ever again exporting to the United States.

If you are a domestic facility and do not register, you too will have committed a prohibited act. The federal government can bring both civil and criminal charges against you.


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What are the responsibilities and obligations of my US FDA Agent as required by the United States government?

The United States Food and Drug Administration has placed significant responsibilities on your U. S. FDA Agent.

Firstly, if you are a foreign facility, you are required by law to appoint a U.S. FDA Agent.

Your U.S. FDA Agent will administer the registration of your facility with the federal government.

Your U.S. FDA Agent is deemed the emergency contact with the FDA, unless you choose to name another. Your U.S. FDA Agent is required under federal regulations to assist the Food and Drug Administration in communication with your facility.

Your U.S. FDA Agent will transmit your responses to questions from the United States government which you are required to answer, concerning your products that are imported into the United States.

Your U.S. FDA Agent will communicate with you in scheduling inspections that may be required by the United States Food and Drug Administration. Your U.S. FDA Agent will be required to receive information or documents from the United States Food and Drug Administration and send the information or documents to you.


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Should my US FDA Agent be independent and not otherwise involved in the import/export business?

Yes. Your US FDA Agent must have the legal capabilities to fulfill its responsibilities to you, confidentially.

Your U.S. FDA Agent is required to be the communications intermediary between you and the United States government. Only a U.S. FDA Agent with responsibilities only to you and not otherwise involved in the import/export business can insure the confidentiality of your information.

Perhaps you have a niche market, or are seeking to exploit a niche market for your products. You cannot risk that a disclosure may be made, even inadvertently, or your trade secrets and confidential information used to your disadvantage, by an agent you selected who is in the same industry as you.

The federal government may send confidential information to you, transmitted by law through your U.S. FDA Agent. Or the federal government may want to ask questions of you about your products and suppliers, transmitted through your U.S. FDA Agent. Those questions and your answers, and even the fact that questions are asked, should stay secret and not be known by anyone who is in your same industry.

Your U.S. FDA Agent should be solely in the business of serving as U.S. FDA Agent so that you can know, as to this requirement, you have placed the responsibility in the hands of a professional company.

You already use other professionals to help your business: customs brokers, freight forwarders, logistics specialists. You do this because each is a specialist in that area; your U.S. FDA Agent is a specialist in this area of serving as your U.S. FDA Agent and registering your facility with the Food and Drug Administration.


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Why do we have to register and appoint a U.S. FDA Agent? What if I already have an agent for my products?

The new term and requirement for a "U.S. Agent" is very specific in the new regulations and does not refer to any agent you might already have for customs or other import purposes. It is a new term referring to a person/company with very different duties and responsibilities. It is the FDA's contact in cases of emergency or possible terrorist threat.

By designating your U.S. FDA Agent and your U.S. FDA Agent registers your facility, your facility can be immediately contacted in the event the United States government learns of potential problems. In addition, your U.S. FDA Agent will act as a required link between your facility and the federal government.


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We are a DRUG company. What do we have to do?

Your company must be registered and all drugs listed, with NDC Number. (Analytical companies must register but do not have to list drugs). Your company must have a US Agent if you are a foreign company. We complete all this for you. We can complete registration (and Labeler Code if you have drugs) within two or three days. We can complete drug listings within one week if everything is in order.

Each drug differing in ingredients, formulation or delivery method inter alia requires a separate NDC Number. We can help explain the differences, and make it easy for you to send us the information we need to complete everything for you.

Send us an email to drugs@fdaagents.com and describe your activity (manufacturer, labeler, analytical lab, etc) and describe your drug products (OTC, sunscreen, sanitizer, etc). We can then provide you with more detailed information about the process.


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Once my U.S. Agent completes my Registration and confirms it, is my facility finished with the registration requirements?

No. Upon registration, your food or beverage facility will be given an FDA Registration Number. This Registration Number must be given on every prior notice of every single shipment of your facility's products into the United States. Medical companies receive an Owner/Operator Number, and Drug companies will appear in the database showing their registration status as current and valid.

In addition, the laws and regulations of the United States government require the owner, operator or person in charge to update a registration within sixty (60) calendar days of any change to the information previously submitted. Changes include for example product changes or name and address changes.

US FDA requires annual registration renewal compliance for Drug companies and Medical Device companies. Food, Beverage and Dietary Supplement companies are required to compliance renewal bi-annually. US Agent compliance renewal is required annually under Standard Terms.


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We are a MEDICAL DEVICE company. What do we have to do?

Medical device companies (manufacturers, importers, exporters, etc.) must register, list their devices and foreign companies must designate a US Agent [FDA Agents]. US importers must list their registered foreign manufacturers. In addition, US FDA charges all medical companies an annual US FDA User Fee.

Go to the “Register Medical” page on the Menu, and then click the link you will see. Then complete the two easy forms, one for registration and one for listing your devices. US FDA charges each medical device company an annual US FDA User Fee. We pay this to US FDA out of the funds you wire transfer/TT to us or using the credit card you provide.

We list all your exempt and 510(k)-Cleared devices, included in our flat fee. Our fee includes, registration, classifying your devices, US Agent service, changes whenever needed and a courtesy Certificate of US FDA Registration. We complete registration and listing within three business days. If you have questions, Send us an email at info@fdaagents.com.


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We are a FOOD, BEVERAGE or DIETARY SUPPLEMENT company but are not sure we have to comply. What do we do, and what are the definitions that apply to us?

Click the “Register Food” menu-item. Create the Account and complete the registration application. It takes about ten minutes. Registration is completed within one to two days, and rush service is available without extra charge if for example your shipment is held in Customs until you are registered.

Facility

"Facility" means any establishment, structure or structures at one general physical location, that manufactures, processes, packs or holds food or beverage for consumption in the United States. If your business is conducted out of more than one location, your U.S. Agent must obtain a registration number for each separate location.

Food

Examples of food include fruits, vegetables, fish, dairy products, eggs, raw agricultural commodities for use as food or components of food, animal feed, food and feed ingredients and additives, infant formula, live food animals, bakery goods, snack foods, candy, and canned foods.

"Food" also means the substances that migrate into food from food packaging and other articles that may contact food.

"Food" also means beverages, including alcoholic beverages and bottled water.

"Food" also means pet food and the components or products that go into making food.

Holding

"Holding" means the storage of food. Examples include warehouses, cold storage facilities, storage silos, grain elevators and liquid storage tanks.

Manufacturing (also "processing")

"Manufacturing" (also "processing") means making food from one or more ingredients, or synthesizing, preparing, treating, modifying or manipulating food, including food crops or ingredients. Examples include cutting, peeling, trimming, washing, waxing, eviscerating, rendering, cooking, baking, freezing, cooling, pasteurizing, homogenizing, mixing, formulating, bottling, milling, grinding, extracting juice, distilling, labeling or packaging.

Packing

"Packing" means placing, putting, or repacking food into different containers without making any change to the form of the food.


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What are the deadlines for registering?

Your company and products must comply with the registration requirement BEFORE your shipments reach the USA Port of Entry. The US FDA requires registration any time before your products enter or are in the US marketplace.


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What concerns should I have about my U.S. FDA Agent?

Your US FDA Agent should be focused on the business of being a U.S. FDA Agent. Your U.S. FDA Agent must have the legal capabilities to fulfill its responsibilities to you.

The laws and regulations in this area change constantly. A professional U.S. FDA Agent focuses on those law and regulations and make sure you stay in full compliance with the law.

The requirements imposed on the U.S. FDA Agent mean that there should not be any potential conflicts of interest by, for example, being an importer, a distributor, a broker or any association.

The federal government may send confidential information to you through the U.S.FDA Agent. Or the federal government may send questions to you, transmitted through your U.S. FDA Agent, about your products or your suppliers. Your answers will be transmitted through your U.S. FDA Agent, and your answers are and should stay secret.

Your U.S. FDA Agent is required to be the communication intermediary between you and the United States Government. Only a U.S. FDA Agent with responsibilities only to you and not otherwise involved in the import business can insure the confidentiality of your information.

This is not information you want in the hands of your distributor, your importer, your broker or an association composed of your direct competitors, who could use the information to their advantage or the advantage of some other client of theirs. Even the knowledge by them that questions are being asked could by hurtful to your business.


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What is the Fee Associated with Registration and Appointment of the U.S. FDA Agent?

FDA Agents' registration, listing and US Agent fee is a flat-fee, and includes at no extra charge registration processing, product listings, amendments whenever needed and US Agent services. Click "Fees" page in the Menu above for exact fees. All FDA Agents' fees are a simple, flat-fee, with all services and Certificate included.


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How can I, as a broker, forwarder, importer or association, help my clients and members comply with the new regulations?

As a professional in your business, you work diligently on behalf of all your many clients or members. You stay aware of all the laws, regulations and trends that affect your business. You realize that it takes only one small change in one regulation to adversely affect your clients' and members' businesses.

Professionals focus on one core business activity and use other professionals to handle related functions. If you are a broker, you use a freight forwarder; if you are an importer, you use a customs broker. Similarly, use of a professional company to serve as your U.S. FDA Agent, an agent whose function is to serve as a required communications link between your clients and members and the U.S. Food and Drug Administration, helps insure the full compliance with the new regulations.

You can help your clients and members by referring them to a professional firm with the background and expertise to register your clients and members with the FDA, as required under the new regulations, and that will serve as U.S. FDA Agent to your foreign clients and members.

A professional company serving as your U.S. FDA Agent focuses on complete awareness of the changing laws and regulations with respect to the registration of foreign facilities. This is critical, as should there be any failure to comply, your clients' or members' products will be denied entry into the United States.

Establishing a relationship of trust and confidence between you, your clients or members, and the U.S. FDA Agent helps everyone. You can know that your clients or members are in compliance with the registration regulations; you can know that communications between the Food and Drug Administration and your clients and members are handled expeditiously and professionally. You can know that all such communications are treated confidentially and will not be disclosed to others or used for any wrongful purpose.


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FDA Agents does not provide legal advice nor serve as legal counsel and any information provided herein is for informational purposes only. You are urged to seek legal counsel should you deem it appropriate for legal advice. FDA Agents is a registration processor and assists with registration, product listing and US Agent service and does so at your specific direction. FDA Agents does not make any determination as to which if any federal, state or local regulations or laws might apply to your situation. FDA Agents is a private company not a part of or affiliated with the US FDA or the US Government.