Which organization oversees the regulation of medical devices in the United States?

The U.S. Food and Drug Administration (FDA) is the organization responsible for overseeing the regulation of medical devices in the United States. This federal agency ensures that medical devices are safe and effective for public use by evaluating their design, manufacturing processes, and labeled claims before they can be marketed. The FDA sets forth guidelines and requirements for premarket submissions, such as 510(k) notifications and premarket approval (PMA), which device manufacturers must comply with to obtain clearance or approval for their products.

In contrast, other organizations mentioned serve different roles within the healthcare landscape. The Centers for Disease Control and Prevention (CDC) focuses primarily on public health and disease prevention, while the National Institutes of Health (NIH) conducts and supports medical research. The World Health Organization (WHO) operates at an international level to coordinate global health initiatives but does not regulate devices within the United States. Thus, the FDA is uniquely positioned to regulate medical devices, ensuring patient safety and effective healthcare outcomes.