(a) Any establishment within any foreign country engaged in the manufacture, preparation, propagation, compounding, or processing of a device that is imported or offered for import into the United States shall register and list such devices in conformance with the requirements in subpart B of this part unless the device enters a foreign trade zone and is re-exported from that foreign trade zone without having entered U. S. commerce. The official correspondent for the foreign establishment shall facilitate communication between the foreign establishment's management and representatives of the Food and Drug Administration for matters relating to the registration of device establishments and the listing of device products.
(b) Each foreign establishment required to register under paragraph (a) of this section shall submit the name, address, and phone number of its United States agent as part of its initial and updated registration information in accordance with subpart B of this part. Each foreign establishment shall designate only one United States agent and may designate the United States agent to act as its official correspondent.
(1) The United States agent shall reside or maintain a place of business in the United States.
(2) Upon request from FDA, the United States agent shall assist FDA in communications with the foreign establishment, respond to questions concerning the foreign establishment's products that are imported or offered for import into the United States, and assist FDA in scheduling inspections of the foreign establishment. If the agency 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.
(3) The foreign establishment or the United States agent shall report changes in the United States agent's name, address, or phone number to FDA within 10-business days of the change.
(c) No device may be imported or offered for import into the United States unless it is the subject of a device listing as required under subpart B of this part and is manufactured, prepared, propagated, compounded, or processed at a registered foreign establishment; however, this restriction does not apply to devices imported or offered for import under the investigational use provisions of part 812 of this chapter or to a component, part, or accessory of a device or other article of a device imported under section 801(d)(3) of the act. The establishment registration and device listing information shall be in the English language.
[66 FR 59160, Nov. 27, 2001]