[Code of Federal Regulations]

[Title 21, Volume 8]

[Revised as of April 1, 2006]

From the U.S. Government Printing Office via GPO Access

[CITE: 21CFR803.58]



[Page 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 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 Sec. Sec.  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.



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

stayed indefinitely.