In Face of COVID-19, FDA Updates Adverse Event Reporting Guidance Document

By MedTech Intelligence Staff

The goal of the guidance is to ensure that manufacturers are prepared to report adverse events during a pandemic.

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

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