[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR803.58]

[Page 54-55]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 803--MEDICAL DEVICE REPORTING--Table of Contents
 
             Subpart E--Manufacturer Reporting Requirements
 
Sec. 803.58  Foreign manufacturers.

    (a) Every foreign manufacturer whose devices are distributed in the 
United States shall designate a U.S. agent to be responsible for 
reporting in accordance with Sec. 807.40 of this chapter. The U.S. 
designated agent accepts responsibility for the duties that such 
designation entails. Upon the effective date of this regulation, foreign 
manufacturers shall inform FDA, by letter, of the name and address of 
the U.S. agent designated under this section and Sec. 807.40 of this 
chapter, and shall

[[Page 55]]

update this information as necessary. Such updated information shall be 
submitted to FDA, within 5 days of a change in the designated agent 
information.
    (b) U.S.-designated agents of foreign manufacturers are required to:
    (1) Report to FDA in accordance with Secs. 803.50, 803.52, 803.53, 
803.55, and 803.56;
    (2) Conduct, or obtain from the foreign manufacturer the necessary 
information regarding, the investigation and evaluation of the event to 
comport with the requirements of Sec. 803.50;
    (3) Forward MDR complaints to the foreign manufacturer and maintain 
documentation of this requirement;
    (4) Maintain complaint files in accordance with Sec. 803.18; and
    (5) Register, list, and submit premarket notifications in accordance 
with part 807 of this chapter.

[60 FR 63597, Dec. 11, 1995, as amended at 66 FR 23157, May 8, 2001]

    Effective Date Note: At 61 FR 38347, July 23, 1996, Sec. 803.58 was 
stayed indefinitely.