The U.S. Food and Drug Administration (FDA) regulates denture adhesives, which are medical devices under the Food, Drug and Cosmetic Act. A denture adhesive is a device intended to be applied to the base of a denture before the denture is inserted in a patient's mouth to improve denture retention and comfort. FDA has classified this product as a low-risk device (class I). While manufacturers are not required to submit marketing applications to FDA for most class I devices, they still must register and list a class I device with the agency and comply with other applicable FDA requirements. These requirements include adverse event reporting, manufacturing controls, and labeling that is neither false nor misleading. FDA monitors adverse events from medical devices through mandatory and voluntary reporting systems. Manufacturers and hospitals are required by law to report deaths and serious injuries. Manufacturers also must report malfunctions that could result in death or serious injury. FDA reviews reports submitted to the agency and has authority to take immediate action, when warranted, to protect public health.