21 C.F.R. § 803.20 How do I complete and submit an individual adverse event report?
(a) What form must I complete and submit?
(1) If you are a health professional or consumer or other entity, you may submit voluntary reports to FDA regarding devices or other FDA-regulated products using the Form FDA 3500.
(2) To submit a mandatory report in written form, a user facility must use Form FDA 3500A.
(3) An electronic submission of a mandatory report from a user facility, importer, or manufacturer must contain the information from the applicable blocks of Form FDA 3500A. All electronic submissions must include information about the patient, the event, the device, and the “initial reporter.” An electronic submission from a user facility or importer must include the information from block F. An electronic submission from a manufacturer must include the information from blocks G and H. If you are a manufacturer and you receive a report from a user facility or importer, you must incorporate that information in your electronic submission and include any corrected or missing information.
(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.
(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 calendar days 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 § 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 § 803.18) the information that the qualified person used to determine whether or not a device-related event was reportable.