Who is responsible for reporting Unanticipated Adverse Device Effects to the FDA?

The responsibility for reporting Unanticipated Adverse Device Effects (UADEs) to the FDA falls on the sponsor of the device. This is because the sponsor, which may include the manufacturer or an entity that is responsible for the device’s development, is tasked with ensuring compliance with regulatory requirements, including the proper reporting of adverse events. They have the necessary resources and obligations to monitor the safety of the device throughout its use in clinical trials and to notify the FDA when unexpected adverse effects arise.

In contrast, while the investigator may collect information on adverse effects during the trial, their primary role is to report such events to the sponsor, who then has the responsibility to convey that information to the FDA. The medical facility conducting the trial acts as a site for the study but does not hold the primary regulatory responsibility for reporting adverse events. Lastly, the external review board, typically referred to as an Institutional Review Board (IRB), plays a role in overseeing the ethical aspects of the study and ensuring participant safety, but it does not have the authority or responsibility to report adverse events to regulatory bodies like the FDA.