[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2001]
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 U.S. agents of foreign manufacturers of devices.


    (a) Each foreign device manufacturer who exports devices into the 
United States shall designate a person as their U.S.-designated agent, 
who is responsible for:
    (1) Submitting MDR reports,
    (2) Submitting annual certifications,
    (3) Acting as the official correspondent,

[[Page 67]]

    (4) Submitting registration information,
    (5) Submitting device listing information, and
    (6) Submitting premarket notifications.
    (b) The foreign manufacturer shall provide FDA with a statement of 
authorization for their U.S.-designate to perform MDR reporting duties 
under part 803 of this chapter, and to register, list, and submit 
premarket notifications under this part. The foreign manufacturer must 
provide this statement of authorization along with the name, address, 
and telephone number of the person initially designated, or any 
subsequent person designated as the U.S.-designated agent, within 5 days 
of the initial or subsequent designation. Information shall be sent to 
the Center for Devices and Radiological Health, Medical Device 
Reporting, Food and Drug Administration, P.O. Box 3002, Rockville, MD 
20847-3002.
    (c) The U.S.-designated agent of a foreign device manufacturer that 
exports devices into the United States is required to register the 
foreign manufacturer's establishments or places of business, and to list 
the foreign manufacturer's devices, in accordance with subpart B of this 
part, unless exempt under subpart D of this part, and to submit 
premarket notifications in accordance with subpart E of this part. The 
information submitted shall be in the English language.

[60 FR 63606, Dec. 11, 1995]

    Effective Date Note: At 61 FR 38347, July 23, 1996, Sec. 807.40 was 
stayed indefinitely.