Which agency is primarily responsible for regulating medical devices in the United States?

The Food and Drug Administration (FDA) is the primary agency responsible for regulating medical devices in the United States. This regulatory role includes overseeing the safety and effectiveness of medical devices before they can be marketed. The FDA's jurisdiction encompasses a wide spectrum of devices, from simple items such as tongue depressors to complex technologies like implantable pacemakers and robotic surgical systems.

The FDA's responsibilities also extend to post-market surveillance, ensuring that any device continues to meet safety and efficacy standards once it is in use by the healthcare community. This includes monitoring adverse events and enforcing regulations around labeling, manufacturing processes, and marketing claims related to medical devices.

In contrast, the other agencies listed have different roles and focus areas. The Centers for Disease Control and Prevention (CDC) is more involved in public health, disease prevention, and health education rather than direct regulation of medical devices. The National Institutes of Health (NIH) primarily focuses on biomedical research and funding rather than regulation. The Federal Trade Commission (FTC) deals with consumer protection and antitrust laws but does not have the regulatory authority over medical devices as the FDA does. Understanding the distinct functions of these agencies highlights why the FDA is the correct choice for this question.