SOCRA CCRP Practice Exam

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Investigators must submit Unanticipated Adverse Device Effects to the FDA within how many working days?

5 working days
10 working days
15 working days
20 working days

The correct answer is: 10 working days

Investigators must submit Unanticipated Adverse Device Effects to the FDA within 10 working days. This time frame is set to ensure timely reporting of any unexpected negative effects that may occur with the use of a medical device in order to protect the public's health and safety. Options A, C, and D are incorrect as they do not meet the required timeline for reporting and could potentially delay the necessary actions that may need to be taken by the FDA.