10412. HOW TO REPORT ADVERSE EVENTS

10412 HOW TO REPORT ADVERSE EVENTS 10412.1 If you are a user facility, you must submit MDR reports to: (a) The manufacturer and to the Department no later than ten (10) business 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 (b) The manufacturer no later than ten (10) business 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 the Department. 10412.2 An importer shall submit MDR reports to: (a) The manufacturer and to the Department, no later than thirty (30) calendar days after the day that the importer becomes aware of information that reasonably suggests that a device has or may have caused or contributed to a death or serious injury; or (b) The manufacturer, no later than thirty (30) days calendar after receiving information that a device the importer marketed has malfunctioned and that this device or a similar device that the importer marketed would be likely to cause or contribute to a death or serious injury if the malfunction were to recur. 10412.3 If you are a manufacturer, you must submit MDR reports to the Department: (a) No later than thirty (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 (b) No later than thirty (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 (c) Within five (5) business days if required by § 10422. 10412.4 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. 10412.5 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 the information that the qualified person used to determine whether or not a device-related event was reportable. SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10412