RAC Regulatory Affairs Certification Exam

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A manufacturer becomes aware that a series of malfunctions with its infusion pump necessitates a nationwide field correction to prevent an unreasonable risk of substantial public harm. The company also has information reasonably suggesting these malfunctions may have contributed to a patient's death. According to 21 CFR 803, what is the mandatory reporting timeframe to the FDA for this event?

30 calendar days after becoming aware of the event. 10 working days after initiating the field correction. 5 working days after becoming aware that a reportable event requires remedial action. Within 24 hours via a phone call to the district office.

Correct Answer:

5 working days after becoming aware that a reportable event requires remedial action.

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