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

The U.S. Food and Drug Administration (FDA) is the primary organization responsible for regulating medical devices in the United States. This agency plays a crucial role in ensuring that medical devices are safe and effective before they can be marketed to the public. The FDA establishes guidelines for the design, manufacturing, and marketing of devices, and it conducts rigorous reviews of premarket applications to assess their safety and efficacy.

The FDA's regulatory framework includes classifications for medical devices based on the level of risk they pose, which determines the required approval pathway. These classifications influence the amount of data and testing required for different types of devices. Additionally, the FDA monitors post-market performance and adverse events associated with medical devices to ensure ongoing safety.

In contrast, other organizations, such as the CDC and NIH, have different roles related to public health and biomedical research. The CDC focuses on disease prevention and health promotion, while the NIH primarily conducts and funds medical research. The WHO is an international public health organization that provides guidance and support for health issues globally but does not have regulatory authority in the U.S. Thus, the FDA remains the key agency for overseeing medical device regulation in the United States.