Medical device sales representatives must report adverse events to comply with FDA guidelines. An adverse event is "any undesirable experience associated with the use of a medical product in a patient." The adverse event should be reported to the FDA when the outcome is: death, life-threatening, hospitalization (either requiring hospitalization where there otherwise would not have been any, or prolonging the patient's hospital stay), disability, congenital anomaly, or requires intervention to prevent permanent impairment or damage. When the adverse event is the suspected cause of any of the previous outcomes, it should be reported to the FDA. The FDA has condensed its reporting guidelines for device manufacturers into a chart.
|REPORTER||WHAT TO REPORT||REPORT FORM #||TO WHOM||WHEN|
|Manufacturers||30 day reports of deaths, serious injuries and malfunctions||Form FDA 3500A||FDA||Within 30 calendar days of becoming aware of an event|
|5-day reports for an event designated by FDA or an event that requires remedial action to prevent an unreasonable risk of substantial harm to the public health||Form FDA 3500A||FDA||Within 5 work days of becoming aware of an event|
In order for medical device manufacturers to avoid liability for failure to comply with FDA reporting standards, the manufacturer should make sure that all sales representatives understand what an adverse event is and what the FDA reporting guidelines require, so that sales representatives know what events they must report and when those events must be reported.
Eric Zalud is chair of the Litigation Practice Group at Benesch, Friedlander, Coplan & Aronoff LLP. He focuses his practice on products liability matters including medical device defense.
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