FDA recently released guidance for manufacturers of medical devices, drugs, combination products and dietary supplements to explain how the agency plans to enforce adverse event reporting requirements during a pandemic. The guidance document, “Postmarket Adverse Event Reporting for Medical Products and Dietary Supplements During a Pandemic”, intends to help companies that are still responsible for reporting adverse events but also may have limited resources as a result of high employee absenteeism, for example. However, FDA emphasizes that the guidance does not “discourage adverse event reporting during a pandemic by firms that are able to continue reporting operations” nor does it “address monitoring and reporting of adverse events that might be imposed as a condition for medical products authorized for emergency use”.
In addition, the guidance states that industry should have plans in place to ensure the continuity of operations during a pandemic. The guidance outlines the following:
- Pandemic preparedness
- Development of a continuity of operations plan in the face of a pandemic
- FDA’s expectations for adverse event reporting during a pandemic
- Reporting requirements after a pandemic