QMC Certified Registered Central Service Technician (CRCST) Progress Practice Test

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Which regulatory body oversees medical device reporting?

National Fire Protection Association.

Environmental Protection Agency.

World Health Organization.

U.S. Food and Drug Administration.

The U.S. Food and Drug Administration (FDA) is responsible for overseeing medical device reporting in the United States. This regulatory body monitors the safety and effectiveness of medical devices through a dedicated system for reporting adverse events associated with their use. The FDA maintains a database where healthcare professionals, patients, and manufacturers can report any issues or malfunctions. This oversight is crucial for public health, as it helps identify potential problems with medical devices and ensures that necessary action can be taken to protect patients.

The other entities mentioned do not have a primary role in medical device reporting. The National Fire Protection Association focuses on fire safety standards, the Environmental Protection Agency manages environmental concerns and regulations, and the World Health Organization directs global health initiatives but does not specifically regulate medical device reporting within the U.S. Thus, the FDA is the correct answer as it directly handles the governance and safety regulations pertinent to medical devices.

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