United States Agent for Devices

Section 417 of the Food and Drug Administration Modernization Act of 1997 requires that any establishment engaged in the manufacture, preparation, propagation, compounding, or processing of a drug or device imported into the United States must register with FDA and identify:

• The name and address of the establishment; and
• The name of the United States agent for the establishment.

On November 27, 2001, FDA published the final regulation implementing these requirements (Federal Register, Vol. 66). The effective date of the regulation is February 11, 2002.

For devices, the new regulation (21 CFR 807.40) states that each foreign establishment may designate only one United States agent who is either a resident of the United States or maintains a place of business in the United States. The foreign establishment may, but is not required to, designate its United States agent as its Official Correspondent.

The responsibilities of the United States agent are limited. They include:

• Assisting FDA in communications with the foreign establishment,
• Responding to questions concerning the foreign establishment's products that are imported or offered for import into the United States, and
• Assisting FDA in scheduling inspections of the foreign establishment.

In addition, if FDA is unable to contact the foreign establishment directly or expeditiously, FDA may provide information or documents to the United States agent, and such an action shall be considered to be equivalent to providing the same information or documents to the foreign establishment.

The requirements for a United States agent in the new regulation are similar to the requirements for a "manufacturer's agent" in the regulations for electronic radiation emitting products (21 CFR 1005.25). Since both regulations are applicable to firms that export to the United States devices that emit electronic radiation, the foreign firm may designate the same agent to satisfy both requirements.

In a similar vein, the regulation outlining requirements for submitting a Pre-market Approval Application (21 CFR 814.20(a)) requires that a foreign applicant identify a "authorized representative residing or maintaining a place of business in the United States." Again, the same agent may satisfy both requirements.

Please note that the United States agent has no responsibility related to reporting of adverse events under the Medical Device Reporting regulation (21 CFR Part 803), or submitting 510(k) Pre-market Notifications (21 CFR 807 Part 807, Subpart E)

Information Published by US Food and Drug Administration - Center for Devices and Radiological Health
31 December 2001