Site Content

Who needs to register?

Domestic and foreign establishments that manufacture, repack, or re-label animal 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. This process is done in conjunction with the human drug registration process.

The Voluntary Cosmetic Registration Program (VCRP) is an FDA post-market reporting system for use by manufacturers, packers, and distributors of cosmetic products that are in commercial distribution in the United States.

​

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. This information helps the FDA maintain a catalog of all drugs in commercial distribution in the United States.

Owners, operators, or agents in charge of domestic or foreign facilities that manufacture/process, pack, or hold food for consumption in the U.S. are required to register the facility with the FDA.

Medical Devices

Owners or operators of places of business (also called establishments or facilities) that are involved in the production and distribution of medical devices intended for use in the United States (U.S.) are required to register annually with the FDA. This process is known as establishment registration.

Filing Radiation Safety (Product) Reports for radiation emitting products is required by law. The FDA eSubmitter software replicates several reporting guides and forms. The electronic templates currently available in eSubmitter represent most forms industry is required to submit to FDA.

Under section 905 of the Tobacco Control Act, every person who owns or operates any domestic establishments engaged in the manufacture, preparation, compounding, or processing of a regulated tobacco product must register those establishments with FDA by December 31 of each year. All registrants must also submit a list of all tobacco products which are being manufactured by that person for commercial distribution, along with certain accompanying information including all labeling.

What is a US Agent?

Foreign manufacturers must identify a verified U.S. agent for their establishment to guarantee entry of their products into the country. The U.S. agent must reside or have a place of business in the United States. This person must be listed during the registration process.

Eligibility for FDA US Agent

​

The US agent must be living in the United States, or the company's bank number is established in the United States.

US agents cannot use a PO Box as an address.

US agents can not only use the service of telephone message.

During normal business hours, an employee must be available to answer the phone and answer questions.

U.S. agent responsibilities:

​

Assist FDA in communication with foreign facilities.

Assist in responding to issues related to the import of products from foreign facilities into the United States.

Assist FDA in contacting and arranging foreign enterprise facility inspection.

If the FDA cannot directly contact the relevant enterprise facility personnel, the FDA can provide relevant document information to its designated US agent. It is legally equivalent to the FDA directly notifying the relevant foreign enterprise facilities.

A common question is wondering if the importer can also act as a US agent. Being a U.S. agent is a responsibility and a risk; the purpose of the U.S. agent is to facilitate communications with foreign agencies, but the U.S. agent may incur some costs. FDA requires designated U.S. agents to confirm their willingness to provide services before FDA can complete registration. Before you specify them, make sure your importer will!

Are FSVP agent the same as US agent?

No, they are not the same. Foreign facilities use U.S. agents as points of contact with FDA. Food facilities require an FSVP agent if there is no U.S. owner or consignee when the shipment enters the U.S. FDA will hold the FSVP Agent accountable for meeting all FSVP requirements. The FSVP representative must be appointed in writing and signed by the FSVP representative.

What happens if I don't register on time?

Thousands of products are held on import each year for not being registered/listed at all or not properly. You might not get caught right away, but Custom's Automated Commerce Environment (ACE) system for brokers makes it more likely. Additionally, FDA may remove (deactivate) a product from its database when a company does not renew its annual or biennial registration.

How do I get FDA-approved certification?

FDA does not issue FDA Certificates of Approval. Companies that specialize in FDA compliance, such as FDAImports, often issue their own certificates verifying that the company has registered its facility with the FDA. These certificates can be valuable in facilitating business with suppliers or clients.

What are the different requirements of each industry?

In addition to device manufacturers (device facilities), all manufacturers and traders are required to submit an FDA-approved unique facility identifier (UFI), such as a DUNS number.

Additionally, each industry has specific rules and information that the FDA requires them to complete the process.