Which law is primarily responsible for governing the safety and effectiveness of medical devices?

The Federal Food, Drug, and Cosmetic Act (FFDCA) is the primary legislation that governs the safety and effectiveness of medical devices in the United States. Enacted in 1938 and subsequently amended, the FFDCA provides the framework for the regulation of food, drugs, and medical devices by the Food and Drug Administration (FDA).

This law sets forth the requirements for premarket approval of medical devices, which involves demonstrating both safety and effectiveness before they can be marketed. It also stipulates the standards for manufacturing practices, labeling, and post-market surveillance, ensuring that medical devices are safe for consumers and perform as intended.

While other laws like the Biologics Control Act pertain to the regulation of biologics (such as vaccines and blood products), and the Drug Enforcement Administration Act focuses on controlled substances, the FFDCA is specifically designed to encompass the range of medical devices, from simple bandages to complex imaging systems. The Medical Devices Regulation Act may refer to regulations under the FFDCA's purview but is not the primary law governing medical devices independently. Thus, the FFDCA stands out as the essential law in this context.