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How are medical devices categorized for regulatory purposes?

  1. Class I, II, III

  2. By their manufacturer

  3. By their usage in medical practice

  4. By their price

The correct answer is: Class I, II, III

Medical devices are categorized by their risk level and level of regulation needed, which determines which category they fall under, not by their manufacturer, usage in medical practice, or price. Class I medical devices pose the lowest risk and are subject to the least amount of regulation, while Class II and III medical devices pose higher risks and are subject to more regulatory oversight. Therefore, Option A is the correct answer as it correctly identifies the order in which medical devices are categorized based on their risk level and level of regulation needed.