Which regulatory body oversees POCT in the United States?

The Food and Drug Administration (FDA) is the regulatory body that oversees Point-of-Care Testing (POCT) in the United States. The FDA is responsible for ensuring that medical devices, including diagnostic tests such as those used in POCT, meet safety and efficacy standards before they can be marketed and used. This involves reviewing the data submitted by manufacturers to determine if the tests are reliable and effective for clinical use.

The FDA's role is particularly important for POCT because these tests must provide accurate results in various settings outside traditional laboratories, such as clinics, emergency rooms, and patients’ homes. The agency evaluates the testing procedures, the technology used, and the specific claims made about the tests to protect public health and ensure that healthcare providers and patients receive reliable tools for diagnosis and monitoring.

The other options play different roles in the healthcare landscape. The Centers for Disease Control and Prevention (CDC) focuses on public health, disease prevention, and control measures; the National Institutes of Health (NIH) conducts and supports medical research; and the American Medical Association (AMA) provides information and advocacy for physicians but does not regulate medical devices or testing. Each of these organizations contributes to the larger healthcare ecosystem but does not have the regulatory authority over POCT that the