Master Regulatory Affairs

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Questions and Answers

What is the purpose of adverse event reporting in postmarket requirements?

  • To monitor distribution and use of devices
  • To detect and report potential issues to FDA (correct)
  • To establish recall procedures
  • To conduct postmarket surveillance studies

What is the purpose of establishing comprehensive recall procedures in postmarket requirements?

  • To monitor distribution and use of devices
  • To address serious problems with devices quickly and effectively (correct)
  • To conduct postmarket surveillance studies
  • To detect and report potential issues to FDA

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