SOCRA CCRP Practice Exam

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How many days does a sponsor have to submit a report to FDA about SR device if the sponsor suggested it was NSR?

Within 3 working days
Within 5 working days
Within 10 working days
Within 15 calendar days

The correct answer is: Within 5 working days

A Within 3 working days is incorrect because the sponsor has 5 working days to submit the report. C: Within 10 working days is incorrect because the sponsor has 5 working days to submit the report. D: Within 15 calendar days is incorrect because the sponsor has 5 working days to submit the report. The correct option is B because according to FDA regulations, a sponsor has 5 working days to submit a report to FDA about a non-significant risk (NSR) device. Therefore, options A, C, and D are incorrect as they provide shorter or longer time frames for report submission, which do not align with the FDA regulations.