Which agency regulates the labeling of single-use medical devices in the United States?

Prepare for the DANB Infection Control Test with multiple choice questions, comprehensive hints, and detailed explanations. Get ready to ace your exam!

The Food and Drug Administration (FDA) is the agency responsible for regulating the labeling of single-use medical devices in the United States. This includes ensuring that the labeling provides accurate and sufficient information for safe usage, as well as meeting necessary regulatory standards. The FDA's authority over medical devices encompasses a variety of aspects including their design, manufacturing, and marketing, with the goal of protecting public health by ensuring these products are safe and effective for their intended use.

In contrast, other agencies mentioned have different primary roles. The Centers for Disease Control and Prevention (CDC) focuses on public health and safety through disease control and prevention guidelines, including infection control practices, but does not regulate medical device labeling. The Occupational Safety and Health Administration (OSHA) is concerned with workplace safety and health regulations rather than specific medical device labeling. The National Institute on Drug Abuse (NIDA) primarily focuses on research and education relating to drug abuse and addiction, and does not play a role in the regulation of medical devices. Thus, the FDA is clearly the correct choice regarding the regulation of labeling for single-use medical devices.

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