[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: 21CFR803.20]

[Page 52-53]
 
                        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 B_Generally Applicable Requirements for Individual Adverse Event 
                                 Reports
 
Sec.  803.20  How do I complete and submit an individual adverse event report?


    (a) What form must I complete and submit? There are two versions of 
the MEDWATCH form for individual reports of adverse events. If you are a 
health professional or consumer, you may use the FDA Form 3500 to submit 
voluntary reports regarding FDA-regulated products. If you are a user 
facility, importer, or manufacturer, you must use the FDA Form 3500A to 
submit mandatory reports about FDA-regulated products.
    (1) If you are a user facility, importer, or manufacturer, you must 
complete the applicable blocks on the front of FDA Form 3500A. The front 
of the form is used to submit information about the patient, the event, 
the device, and the ``initial reporter'' (i.e., the first person or 
entity who reported the information to you).
    (2) If you are a user facility, importer, or manufacturer, you must 
complete the applicable blocks on the back of the form. If you are a 
user facility or importer, you must complete block F. If you are a 
manufacturer, you must complete blocks G and H. If you are a 
manufacturer, you do not have to recopy information that you received on 
a Form 3500A unless you are copying the information onto an electronic 
medium. If you are a manufacturer and you are correcting or supplying 
information that is missing from another reporter's Form 3500A, you must 
attach a copy of that form to your report form. If you are a 
manufacturer and the information from another reporter's Form 3500A is 
complete and correct, you may fill in the remaining information on the 
same form and submit it to us.
    (b) To whom must I submit reports and when?
    (1) If you are a user facility, you must submit MDR reports to:
    (i) The manufacturer and to us no later than 10 work days after the 
day that you become aware of information that reasonably suggests that a 
device has or may have caused or contributed to a death; or
    (ii) The manufacturer no later than 10 work days after the day that 
you become aware of information that reasonably suggests that a device 
has or may have caused or contributed to a serious injury. If the 
manufacturer is not known, you must submit this report to us.

[[Page 53]]

    (2) If you are an importer, you must submit MDR reports to:
    (i) The manufacturer and to us, no later than 30 calendar days after 
the day that you become aware of information that reasonably suggests 
that a device has or may have caused or contributed to a death or 
serious injury; or
    (ii) The manufacturer, no later than 30 days calendar after 
receiving information that a device you market 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.
    (3) If you are a manufacturer, you must submit MDR reports to us:
    (i) No later than 30 calendar days after the day that you become 
aware of information that reasonably suggests that a device may have 
caused or contributed to a death or serious injury; or
    (ii) No later than 30 calendar days after the day that you become 
aware of information that reasonably suggests a device 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; or
    (iii) Within 5 work days if required by Sec.  803.53.
    (c) What kind of information reasonably suggests that a reportable 
event has occurred?
    (1) Any information, including professional, scientific, or medical 
facts, observations, or opinions, may reasonably suggest that a device 
has caused or may have caused or contributed to an MDR reportable event. 
An MDR reportable event is a death, a serious injury, or, if you are a 
manufacturer or importer, a malfunction that would be likely to cause or 
contribute to a death or serious injury if the malfunction were to 
recur.
    (2) If you are a user facility, importer, or manufacturer, you do 
not have to report an adverse event if you have information that would 
lead a person who is qualified to make a medical judgment reasonably to 
conclude that a device did not cause or contribute to a death or serious 
injury, or that a malfunction would not be likely to cause or contribute 
to a death or serious injury if it were to recur. Persons qualified to 
make a medical judgment include physicians, nurses, risk managers, and 
biomedical engineers. You must keep in your MDR event files (described 
in Sec.  803.18) the information that the qualified person used to 
determine whether or not a device-related event was reportable.