Reporting Device-Associated Death Events to the FDA

To the Editor We write to respond to a recent report by Dr Lalani and colleagues¹ regarding device-associated adverse events reported to the US Food and Drug Administration (FDA). Adverse event reports submitted to the MAUDE (Manufacturer and User Facility Device Experience) database² are an important tool in the postmarket surveillance of medical devices. The FDA provides public access to these data to promote transparency and the opportunity for research and analyses. We write to address the following points.