[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: 21CFR803.50]

[Page 52]
 
                        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. 803.50  Individual adverse event reports; manufacturers.


    (a) Reporting standards. Device manufacturers are required to report 
within 30 days whenever the manufacturer receives or otherwise becomes 
aware of information, from any source, that reasonably suggests that a 
device marketed by the manufacturer:
    (1) May have caused or contributed to a death or serious injury; or
    (2) Has malfunctioned and such device or similar device marketed by 
the manufacturer would be likely to cause or contribute to a death or 
serious injury, if the malfunction were to recur.
    (b) Information that is reasonably known to manufacturers. (1) 
Manufacturers must provide all information required in this subpart E 
that is reasonably known to them. FDA considers the following 
information to be reasonably known to the manufacturer:
    (i) Any information that can be obtained by contacting a user 
facility, distributor and/or other initial reporter;
    (ii) Any information in a manufacturer's possession; or
    (iii) Any information that can be obtained by analysis, testing or 
other evaluation of the device.
    (2) Manufacturers are responsible for obtaining and providing FDA 
with information that is incomplete or missing from reports submitted by 
user facilities, distributors, and other initial reporters. 
Manufacturers are also responsible for conducting an investigation of 
each event, and evaluating the cause of the event. If a manufacturer 
cannot provide complete information on an MDR report, it must provide a 
statement explaining why such information was incomplete and the steps 
taken to obtain the information. Any required information not available 
at the time of the report, which is obtained after the initial filing, 
must be provided by the manufacturer in a supplemental report under 
Sec. 803.56.