Which act governs the approval process for medical devices in the U.S.?

The Federal Food, Drug, and Cosmetic Act is the primary legislation that governs the approval process for medical devices in the United States. This act, originally passed in 1938 and significantly amended multiple times, provides the Food and Drug Administration (FDA) with the authority to regulate the safety and effectiveness of medical devices before they can be marketed. Under this act, medical devices are classified into categories that dictate the level of regulatory scrutiny applicable to each device type, based on their intended use and the risks they pose to patients.

This framework ensures that devices meet necessary standards for safety and efficacy, protecting public health. While there may be other acts that relate to healthcare and medical devices, none provide the comprehensive regulatory structure that the Federal Food, Drug, and Cosmetic Act does for the approval of medical devices.