[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: 21CFR803.40]

[Page 50-51]
 
                        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 D--Importer Reporting Requirements
 
Sec. 803.40  Individual adverse event reporting requirements; importers.

    Source: 65 FR 4120, Jan. 26, 2000, unless otherwise noted.


    (a) An importer shall submit to FDA a report, and a copy of such 
report to the manufacturer, containing the information required by 
Sec. 803.42 on FDA form 3500A as soon as practicable, but not later than 
30 days after the importer receives or otherwise becomes aware of 
information from any source, including user facilities, individuals, or 
medical or scientific literature, whether published or unpublished, that 
reasonably suggests that one of its marketed devices may have caused or 
contributed to a death or serious injury.
    (b) An importer shall submit to the manufacturer a report containing 
information required by Sec. 803.42 on FDA form 3500A, as soon as 
practicable, but not later than 30 days after the importer receives or 
otherwise becomes aware of information from any source, including user 
facilities, individuals, or

[[Page 51]]

through the importer's own research, testing, evaluation, servicing, or 
maintenance of one of its devices, that one of the devices marketed by 
the importer has malfunctioned and that such device or a similar device 
marketed by the importer would be likely to cause or contribute to a 
death or serious injury if the malfunction were to recur.