CDRH's Voluntary Malfunction Summary Reporting Program

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.

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