SOCRA CCRP Practice Exam

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Class III medical devices are subject to which of the following?

  1. General controls only

  2. General controls + special controls

  3. General controls + premarket approval

  4. Special controls only

The correct answer is: General controls + premarket approval

Class III medical devices are subject to both general controls and premarket approval. These are the highest risk devices and therefore require the most stringent regulations for safety and effectiveness. General controls alone are not enough to ensure the safety and effectiveness of these devices, which is why premarket approval is also necessary. Special controls, while important for lower risk devices, are not sufficient for Class III medical devices.

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