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The sponsor-investigator must immediately evaluate any unanticipated adverse device effect. If the sponsor-investigator determines that the device presents an unreasonable risk to the safety of subjects, the sponsor-investigator must terminate the study within 5 working days after making this determination, but not later than 15 working days after first receiving notice of the adverse effect.
If the device is significant risk, the sponsor-investigator may not resume a terminated investigation without IRB and FDA approval. If the device is nonsignificant risk, the sponsor-investigator may not resume a terminated investigation without IRB approval.