[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR803.20]

[Page 47-48]
 
                        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 to report.


    (a) Description of form. There are two versions of the MEDWATCH form 
for individual reports of adverse events. FDA Form 3500 is available for 
use by health professionals and consumers for the submission of 
voluntary reports regarding FDA-regulated products. FDA Form 3500A is 
the mandatory reporting form to be used for submitting reports by user 
facilities, importers, and manufacturers of FDA-regulated products. The 
form has some sections that must be completed by all reporters and other 
sections that must be completed only by the user facility, importer, or 
manufacturer.
    (1) The front of FDA Form 3500A is to be filled out by all 
reporters. The front of the form requests information regarding the 
patient, the event, the device, and the ``initial reporter'' (i.e., the 
first person or entity that submitted the information to the user 
facility, manufacturer, or importer).
    (2) The back part of the form contains sections to be completed by 
user facilities, importers, and manufacturers. User facilities and 
importers must complete section F; device manufacturers must complete 
sections G and H. Manufacturers are not required to recopy information 
submitted to them on a Form 3500A unless the information is being copied 
onto an electronic medium. If the manufacturer corrects or supplies 
information missing from the other reporter's 3500A form, it should 
attach a copy of that form to the manufacturer's report form. If the 
information from the other reporter's 3500A form is complete and 
correct, the manufacturer can fill in the remaining information on the 
same form.
    (b) Reporting standards. (1) User facilities are required to submit 
MDR reports to:
    (i) The device manufacturer and to FDA within 10 days of becoming 
aware of information that reasonably suggests that a device has or may 
have caused or contributed to a death; or
    (ii) The manufacturer within 10 days of becoming aware of 
information that reasonably suggests that a device has or may have 
caused or contributed to a serious injury. Such reports shall be 
submitted to FDA if the device manufacturer is not known.
    (2) Importers are required to submit death and serious injury 
reports to FDA and the device manufacturer and submit malfunction 
reports to the manufacturer only:
    (i) Within 30 days of becoming aware of information that reasonably 
suggests that a device has or may have caused or contributed to a death 
or serious injury.
    (ii) Within 30 days of receiving information that a device marketed 
by the importer has malfunctioned and that such a 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.
    (3) Manufacturers are required to submit MDR reports to FDA:
    (i) Within 30 days of becoming aware of information that reasonably 
suggests that a device may have caused or contributed to a death or 
serious injury; or
    (ii) Within 30 days of becoming aware of information that reasonably 
suggests a device has malfunctioned and

[[Page 48]]

that device or a similar device marketed by the manufacturer would be 
likely to cause a death or serious injury if the malfunction were to 
recur; or
    (iii) Within 5 days if required by Sec. 803.53.
    (c) Information that reasonably suggests a reportable event 
occurred. (1) Information that reasonably suggests that a device has or 
may have caused or contributed to an MDR reportable event (i.e., death, 
serious injury, and, for manufacturers and importers, a malfunction that 
would be likely to cause or contribute to a death or serious injury if 
the malfunction were to recur) includes any information, such as 
professional, scientific or medical facts and observations or opinions, 
that would reasonably suggest that a device has caused or may have 
caused or contributed to a reportable event.
    (2) Entities required to report under this part do not have to 
report adverse events for which there is information that would cause a 
person who is qualified to make a medical judgment (e.g., a physician, 
nurse, risk manager, or biomedical engineer) to reach a reasonable 
conclusion 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. Information 
which leads the qualified person to determine that a device-related 
event is or is not reportable must be contained in the MDR event files, 
as described in Sec. 803.18.

[60 FR 63597, Dec. 11, 1995, as amended at 65 FR 4119, Jan. 26, 2000; 66 
FR 23157, May 8, 2001]