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2 Questions

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Master Regulatory Affairs

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@HardWorkingAffection

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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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