Which organization also oversees medical devices, in addition to the FDA?

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Prepare for the Biomedical Equipment Technician (BMET) CDC Set A Volume 5 Exam. Enhance your understanding with flashcards and multiple-choice questions, each with hints and explanations. Ace your BMET exam!

The International Organization for Standardization (ISO) plays a crucial role in the oversight of medical devices by establishing global standards that ensure the quality, safety, and efficiency of these devices. ISO develops guidelines that manufacturers must follow, addressing various aspects of medical devices including design, manufacturing, testing, and performance. These standards help facilitate international trade and provide a framework for regulatory compliance across different countries.

While the FDA is responsible for the approval and regulation of medical devices within the United States, ISO's standards are used worldwide, impacting how devices are developed and marketed internationally. This cooperation between national regulatory bodies like the FDA and global organizations such as ISO is essential for ensuring that medical devices meet stringent safety and effectiveness criteria before they reach the market.

The other organizations listed, while influential in public health and safety, do not specifically focus on the standardization and regulatory framework for medical devices in the same comprehensive manner as ISO.

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