Which regulation governs the production and marketing of medical devices in the United States?

The Federal Food, Drug, and Cosmetic Act (FDCA) is the cornerstone regulation that governs the production and marketing of medical devices in the United States. Enacted in 1938, this comprehensive law provides the FDA with the authority to oversee the safety and efficacy of medical devices, ensuring they meet regulatory standards before and after they enter the market.

Under the FDCA, medical devices are classified into categories based on their level of risk, and the regulation sets forth requirements for pre-market approval, manufacturing practices, labeling, and reporting of adverse events. This framework is essential for protecting public health by regulating devices ranging from simple bandages to complex surgical instruments.

Other options like the Medical Device Regulation Act and the Device Safety Act do not exist as standalone acts under U.S. law governing medical devices. The Health Protection Act, while it may relate to public health, does not specifically address the regulatory pathway for medical devices as comprehensively as the FDCA. Therefore, the FDCA is the definitive regulation for ensuring the safety and effectiveness of medical devices in the United States market.