What Act requires health care facilities to report death or injuries caused by or suspected to have been caused by a medical device?

The Safe Medical Device Act is the legislation that mandates health care facilities to report any deaths or serious injuries that may have been caused by medical devices. This Act was enacted to enhance the Food and Drug Administration's (FDA) ability to monitor medical devices and ensure their safety and effectiveness. Under this law, facilities must report device-related incidents, allowing for timely identification and evaluation of potential safety issues. This requirement promotes patient safety by ensuring that adverse events are documented and investigated, which can lead to necessary recalls or warnings regarding potentially hazardous medical devices.

The other acts mentioned in the choices do not focus specifically on the reporting of incidents involving medical devices. The Food, Drug, and Cosmetic Act primarily governs the regulation of food, drugs, and cosmetics but does not specifically address reporting requirements related to medical devices. The Kefauver-Harris Amendment, while it deals with drug efficacy and safety, does not cover the reporting of device-related injuries. Lastly, the Poison Prevention Packaging Act is concerned with the packaging of hazardous household substances to prevent accidental poisoning, rather than oversight of medical devices. Thus, the Safe Medical Device Act is the correct answer as it directly pertains to the reporting requirements related to medical devices.