Certified Biomedical Equipment Technician (CBET) 2025 – 400 Free Practice Questions to Pass the Exam

The regulation that governs the safety of medical devices in the United States is the Federal Food, Drug, and Cosmetic Act (FDCA). This comprehensive legislation grants the Food and Drug Administration (FDA) the authority to oversee the safety, efficacy, and security of not only food and drugs but also medical devices. Under the FDCA, medical devices are classified into categories based on their level of risk, which determines the regulatory controls required for their approval and monitoring.

This act establishes the framework for the FDA to evaluate new medical devices before they can enter the market and ensures that existing devices are continually assessed for safety and effectiveness. It plays a critical role in protecting public health by ensuring that manufacturers adhere to safety standards and labeling requirements.

The other choices pertain to different aspects of healthcare regulation. The Medical Device Safety Act, while relevant, does not encompass the broader governing framework that the FDCA represents. The Health Insurance Portability Act primarily focuses on the protection of health information and privacy, and thus is not related to medical device safety. The Drug Enforcement Administration Regulations concern the control of narcotics and other controlled substances, not the regulation of medical devices.