Who must report Evaluation of Unanticipated Adverse Device Effects (UADEs) to the FDA?

The responsibility to report Evaluation of Unanticipated Adverse Device Effects (UADEs) to the FDA lies with the sponsor of the clinical trial. The sponsor is the entity that has the legal and regulatory responsibility for the conduct of the trial, including the oversight of the safety of the investigational device. According to FDA regulations, when a UADE occurs, the sponsor is required to evaluate the event and report it to the FDA as part of their obligations to ensure participant safety and compliance with regulatory standards.

While the Institutional Review Board (IRB) and the investigators play crucial roles in overseeing the ethical conduct of research and protecting participants, they do not have the same reporting obligations to the FDA regarding UADEs. The IRB reviews the study protocols and monitors adverse events to ensure the ethical treatment of participants, and investigators are responsible for reporting adverse events to the sponsor. However, the ultimate duty to report UADEs to the FDA rests with the sponsor, who synthesizes information from various sources, including investigators and IRBs, to fulfill this regulatory requirement.