SOCRA CCRP Practice Exam

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What is required for the submission of a Premarket Approval Application?

  1. Endorsement by a medical professional

  2. Clinical trials in humans

  3. A petition signed by potential users

  4. Evidence of patent

The correct answer is: Clinical trials in humans

To submit a Premarket Approval Application, clinical trials in humans are required to be conducted and submitted to the appropriate regulatory agency. Endorsement by a medical professional, while important for the application process, is not a required component. A petition signed by potential users also may not be necessary for the submission of a Premarket Approval Application. Additionally, evidence of patent is not a required element for the submission of a Premarket Approval Application.

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