In Face of COVID-19, FDA Updates Adverse Event Reporting Guidance Document
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
Related Articles
-
The draft guidance proposes updates to clarify how the Breakthrough Devices Program may be applicable to certain medical devices that promote health equity, as well as considerations in designating eligible devices that may benefit populations impacted by disparities in health…
-
The updated guidance document clarifies what constitutes a statement of the basis for the deficiency and includes examples of well-constructed deficiencies and industry responses to facilitate a more efficient review process.
-
The new guidance is intended to establish confidence in automation used for production or quality assurance systems and describe various methods and testing activities that may be applied to establish computer software assurance and meet regulatory software validation requirements.
-
Manufacturers preparing premarket submissions should provide performance specifications for the quantitative imaging functions, supporting performance data, and sufficient information for the end user to obtain, understand and interpret the values provided.
