[Code of Federal Regulations]

[Title 21, Volume 8]

[Revised as of April 1, 2006]

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 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 48]]



    (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.