Which Congressional Act provided Statutory Authority to FDA to regulate medical devices?

The Medical Device Amendments of 1976 are fundamental in establishing the FDA's authority to regulate medical devices. This Act was the first to specifically define medical devices and categorize them into classes based on the level of risk they pose to patients. It established a framework for the classification of devices, premarket approval requirements, and the standards for device safety and efficacy that must be met before products can be marketed.

Prior to this Act, medical devices were regulated under the Federal Food, Drug, and Cosmetic Act, which primarily focused on food and drugs but did not adequately address the unique nature and risks associated with medical devices. The 1976 Amendments corrected this by introducing a more comprehensive regulatory process tailored to the complexities of medical devices.

As a result, this Act created the foundation for the FDA’s oversight of medical devices, ensuring that they are safe and effective for public use. It remains a key piece of legislation that continues to influence the regulation of medical devices today.