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