On November 27, 2001, the Food and Drug Administration (FDA) issued a final regulation amending its rules governing registration and listing requirements for non-U.S. companies that manufacture, process, or distribute drugs (including biologic drugs) or medical devices for export to the U.S. The new requirements take effect on February 11, 2002, The FDA will begin enforcing the requirements on April 26, 2002, for devices and on May 28, 2002, for drugs.

New Requirements

The regulation implements requirements included in the Food and Drug Administration Modernization Act of 1997 (FDAMA). The statute and regulation contain two new requirements for non-U.S. companies:

1. Registration Requirement: Non-U.S. companies that manufacture, prepare, propagate, compound, or process a drug or medical device that is imported into the U.S. must now register with FDA. Previously, non-U.S. companies were required to list drugs and devices offered for sale in U.S. markets with FDA; however, the companies themselves were not required to register with FDA.

2. Designation of U.S. Agent: Non-U.S. companies that engage in any of the activities listed above must designate a United States Agent. According to the regulation, “FDA wants the United States agent to assist in communications with the foreign establishment, to respond to questions about the foreign establishment’s products, and to help schedule inspections of the foreign establishment.” 66 Fed. Reg. 59138 at 59142. The U.S. Agent must maintain a physical address in the United States; this requirement cannot be met by maintaining a mailbox, answering machine or service, or other place where the agent is not physically present. Registering with FDA

Companies may register with the FDA by submitting a properly completed Form FDA 2656 (for drugs) or Form FDA 2891 (for medical devices). The regulation provides limited exceptions to the registration requirement. For example, a company is not required to register if its products enter a foreign trade zone and are re-exported from that foreign trade zone, or if its products are imported for investigational use.

Designating a U.S. Agent

The three FDA Centers that will be enforcing the new requirements-the Center for Drug Evaluation and Research (CDER), the Center for Devices and Radiological Health (CDRH), and the Center for Biologics Evaluation and Research (CBER)-have each stated that they intend to revise their respective registration forms in response to the new requirements. However, it is likely that the process of form revision (and subsequent approval by the Office of Management and Budget) will take several months or longer. In the interim, officials in each center have stated that a company should send a letter providing the name and address of their designated U.S. Agent to the appropriate Center. Companies registering for the first time should send this letter with their registration form. Companies that are currently registered may send the letter by itself. Companies registered with CBER and CDRH will not have to re-register, according to officials in each of these centers. Companies registered with CDER may be required to submit new registration forms, including the U.S. Agent information, at some point in the future.

Companies should keep in mind the following points when selecting and utilizing a U.S. Agent:

• A company may choose ONLY ONE U.S. Agent. Therefore, companies should carefully consider proprietary issues such as confidentiality when selecting the U.S. Agent.
• The company must submit the name and address of the U.S. Agent when filing its registration form with FDA (see #1 above).
• A company is not required to have its U.S. Agent submit any forms (including registration, listing, and other forms) to FDA; however the company may have the Agent prepare and submit forms on its behalf at its discretion.
• A company may continue to contact FDA directly, and the FDA may also contact the company directly. If FDA is unable to contact a company, however, FDA may provide information or documents to the U.S. Agent in lieu of the company. This action will be considered equivalent to providing the information directly to the company.
• A company must report changes in the name or address of its U.S. Agent within 10 business days of the change. The U.S. Agent may report this information to FDA on the company’s behalf.