FSCA (field safety corrective action)

A field safety corrective action is the action a manufacturer takes in the field to reduce a risk of death or serious deterioration of the state of health associated with a device.

The communication that goes with it is often a field safety notice. MDSAP tasks on advisory notices and on nonconforming product detected after delivery are where an auditor looks for the decision, the notice and the evidence that it worked. Timelines differ by jurisdiction. Confirm them with the authority for each market, and with the EU vigilance rules, before you publish a number.

HAVGATE can hold the investigation as a CAPA and the procedure as a controlled document. It does not file the notice with an authority.