Does the law cover any reaction or complaint to any product I carry or manufactureno matter how minor?
No. The AER law will not require reporting of all complaints; but instead will be limited to serious adverse events. “Serious” adverse events as defined in the law are: • death; • a life-threatening experience; • inpatient hospitalization; • a persistent or significant disability or incapacity; • a congenital anomaly or birth defect; or, • require medical or surgical intervention to prevent the above outcomes. Although the AER law only requires that reports of “serious” adverse events be submitted to FDA, records of other types of product complaints or adverse events must be maintained for a period of six years by the responsible person.
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