[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR803.40]

[Page 56]
 
                        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  If I am an importer, what kinds of individual adverse event 


reports must I submit, when must I submit them, and to whom must I submit 

them?

    (a) Reports of deaths or serious injuries. You must submit a report 
to us, and a copy of this report to the manufacturer, as soon as 
practicable but no later than 30 calendar days after the day that you 
receive or otherwise become 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literature, whether published or unpublished, that reasonably suggests 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 your marketed devices may have caused or contributed to a 
death or serious injury. This report must contain the information 
required by Sec.  803.42, on FDA form 3500A or an electronic equivalent 
approved under Sec.  803.14.
    (b) Reports of malfunctions. You must submit a report to the 
manufacturer as soon as practicable but no later than 30 calendar days 
after the day that you receive or otherwise become aware of information 
from any source, including user facilities, individuals, or through your 
own research, testing, evaluation, servicing, or maintenance of one of 
your devices, that reasonably suggests that one of your devices has 
malfunctioned and that this device or a similar device that you market 
would be likely to cause or contribute to a death or serious injury if 
the malfunction were to recur. This report must contain information 
required by Sec.  803.42, on FDA form 3500A or an electronic equivalent 
approved under Sec.  803.14.