CRCST Practice Exam

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Medical device labeling is regulated by:

  1. The European Medicines Agency

  2. The US Food and Drug Administration

  3. The World Health Organization

  4. The Centers for Disease Control and Prevention

The correct answer is: The US Food and Drug Administration

Medical device labeling is regulated by the US Food and Drug Administration (FDA). This government agency is responsible for enforcing regulations and ensuring that all medical devices sold in the US meet safety and effectiveness requirements. The European Medicines Agency (EMA) primarily regulates medications, not medical devices. The World Health Organization (WHO) provides global health guidance and assistance, but does not have regulatory authority over medical device labeling. The Centers for Disease Control and Prevention (CDC) focuses on preventing and controlling disease, but does not regulate medical device labeling. Therefore, the FDA is the most appropriate answer for this question.

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