SOCRA CCRP Practice Exam

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What risk level do Class III devices present?

  1. No significant risk

  2. Minimal risk

  3. Moderate risk

  4. Significant risk

The correct answer is: Significant risk

Class III devices present the highest level of risk compared to the other options listed. Class III devices are considered to have significant risk because they are intended to support or sustain human life or are of substantial importance in preventing impairment of human health. This means that failure or malfunction of a Class III device could have serious consequences for the patient. The other options, A No significant risk, B: Minimal risk, and C: Moderate risk, are all incorrect because Class III devices are not associated with any of those levels of risk. Class III devices are tightly regulated and require pre-market approval by the FDA to ensure their safety and effectiveness.

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