Field safety corrective action

The manufacturer will then conduct a full investigation of the incident to determine the cause and the actions that must be taken in order to rectify the situation and/or prevent a reoccurrence. This may often result in a Field Safety Corrective Action (FSCA), whereby devices should be removed or modified in the field to avoid the risk of death or serious deterioration in the state of health associated... 

The Competent Authority to which the incident was originally reported usually takes on the role of monitoring and evaluating how the incident is dealt with. When all actions are complete, including any necessary Field Safety Correction Actions, the manufacturer must submit a final report to the Competent Authority. Under a safeguard clause. Competent Authorities may take unilateral action to remove a device from their market, if they believe that it poses an unacceptable health risk, but the Commission must be informed of such actions. In less-urgent situations, concerns may be referred to the Committee for Medical Devices for consideration. 

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