SOCRA CCRP Practice Exam

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

5 working days
7 working days
10 working days
15 working days

The correct answer is: 10 working days

Unanticipated Adverse Device Effects must be reported to the FDA within 10 working days. This is because it is important for the FDA to be informed of any adverse effects that were not predicted or expected, in a timely manner. Option A and B (5 and 7 working days) may not be enough time to properly evaluate and report the situation. Option D (15 working days) may be too long, as the FDA may need to take immediate action to protect the public from further harm. Therefore, option C (10 working days) strikes a balance between prompt reporting and thorough evaluation.