[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR807.40]

[Page 66-67]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 807--ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR MANUFACTURERS AND INITIAL IMPORTERS OF DEVICES--Table of Contents
 
  Subpart C--Registration Procedures for Foreign Device Establishments
 
Sec. 807.40  Establishment registration and device listing for foreign establishments importing or offering for import devices into the United States.


    (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

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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]