On August 17, 2018, the Food and Drug Administration (FDA) released the Medical Device Voluntary Malfunction Summary Reporting Program (VMSRP) agreed between industry and the FDA as a part of the Medical Device User Fee Amendments (MDUFA IV) commitment letter. A summary reporting system for malfunctions was first contemplated in the FDA Amendments Act (FDAAA) in 2007. Congress directed the agency to enable summary reporting for all class I devices and for those class II devices that were not life-supporting, life sustaining, or permanent implants. Until now, the agency has not implemented the FDAAA provision and provided alternatives, including summary reporting, only following an application by a specific company and the FDA agreement that summary reporting was appropriate for the device and in the situations outlined in the application.