Hospitals, healthcare facilities, and manufacturers should report medical device malfunction that leads to death or serious injury to which of the following agencies per the Safe Medical Devices Act?

The correct answer is the Food and Drug Administration (FDA), which is designated as the agency responsible for overseeing the safety and efficacy of medical devices. Under the Safe Medical Devices Act, it is mandated that any medical device malfunction that results in death or serious injury must be reported to the FDA. This agency handles the regulation and monitoring of medical devices, ensuring that they meet strict safety standards and addressing issues such as malfunctions or adverse effects to protect public health.

The Centers for Disease Control and Prevention (CDC) primarily focuses on public health and disease control rather than the regulation of medical devices. The Occupational Safety and Health Administration (OSHA) is concerned with workplace safety and health, and does not oversee medical device safety. The National Institutes of Health (NIH) is focused on medical research and funding rather than regulation. Each of these agencies has distinct roles, making the FDA the appropriate authority for reports related to medical device malfunctions under the Safe Medical Devices Act.