DANB Infection Control (ICE) Practice Exam 2025 – Complete Prep Guide

The Food and Drug Administration (FDA) regulates medical sterilizers because they are classified as medical devices. The FDA ensures that all medical devices, including sterilizers, meet established safety and effectiveness standards before they can be marketed and used in healthcare settings. This includes overseeing the manufacturing processes, which ensures they comply with good manufacturing practices, and evaluating the performance of these devices in clinical use.

While the other agencies mentioned do have important roles, their focus is different. The Environmental Protection Agency (EPA) typically deals with environmental protection and safety regulations, which can include some sterilization processes but not specifically the regulation of sterilizers as medical devices. The Occupational Safety and Health Administration (OSHA) is primarily concerned with workplace safety and health regulations, enforcing compliance with standards that protect workers. The Centers for Disease Control and Prevention (CDC) focuses on disease prevention and public health but does not regulate medical devices.

Therefore, the FDA's specific authority and responsibility are why it stands out as the correct answer regarding the regulation of medical sterilizers.