Remedial action

Under 21 CFR 803, an event that needs remedial action to prevent an unreasonable risk of substantial harm to public health calls for a five-day report. Routine maintenance and servicing do not count as remedial action.

Remedial action means any action other than routine maintenance or servicing of a device where such action is necessary to prevent recurrence of a reportable event.

21 CFR, 803.3