Question

Which law requires the reporting of deaths and severe complications due to devices?

A. Medical Implantation and Transplantation Act. 1986
B. Medical Devices Reporting Act of 1972
C. Food and Drug Modernization Act of 1997
D. Safe Medical Devices Act of 1990

Answer 1

The Safe Medical Devices Act of 1990 requires the reporting of adverse events related to medical devices to the FDA, and is overseen by the FDA's Center for Devices and Radiological Health.

Step-by-step explanation:

The law that requires the reporting of deaths and severe complications due to devices is the Safe Medical Devices Act of 1990. This act mandates that manufacturers, importers, and user facilities report certain device-related adverse events to the Food and Drug Administration (FDA). Hospitals and other facilities must report incidents in which medical devices may have contributed to death or serious injury as well as certain malfunctions that could lead to death or serious injury if recurrent. The Center for Devices and Radiological Health (CDRH) is the branch of the FDA responsible for overseeing these reports as well as the safety of medical devices.