SOCRA CCRP Practice Exam

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How are medical devices categorized for regulatory purposes?

  1. By their manufacturing process

  2. By their retail price

  3. SR vs. NSR vs. exempt

  4. By their color and size

The correct answer is: SR vs. NSR vs. exempt

Medical devices are categorized for regulatory purposes based on their risk level as determined by their intended use and potential harm to patients. The categories include significant risk (SR), non-significant risk (NSR), and exempt. Options A, B, and D are not relevant to the categorization process and do not reflect the level of risk associated with the medical device.

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