Which Congressional Act provided statutory authority to the FDA to regulate medical devices?

The choice of the Medical Device Amendments of 1976 is accurate because this legislation specifically granted the FDA the authority to regulate medical devices. Prior to this act, there was no distinct framework for the regulation of medical devices, which were often subject to the more general provisions of the Federal Food, Drug, and Cosmetic Act. The amendments established categories for devices, defined their regulatory pathways, and introduced controls for device safety and efficacy. This foundational act marked a significant evolution in how medical devices are monitored and ensured the FDA has the necessary authority to oversee their development, approval, and post-marketing surveillance.

The other options pertain to subsequent developments in medical device regulation but do not serve as the primary act that conferred regulatory authority to the FDA. For instance, while the Safe Medical Devices Act of 1990 revisited some aspects of device regulation and enhanced reporting requirements, it did not create the initial regulatory framework. Similarly, the Medical Device User Fee and Modernization Act of 2002 focused on user fees and expedited approvals for devices but did not establish the FDA's regulatory authority. The Federal Food, Drug, and Cosmetic Act encompasses food and drug safety but is not specific to medical devices and does not reference their regulatory specifics. Thus, the Medical