Field safety corrective action (FSCA) is a post market requirement that need to be followed by an establishment under Section 41 of Act 737.
The establishment is required to take proactive steps to inform the authority as well as their customers/end-users on the corrective actions made to ensure compliance of these requirements.
Manufacturers or their representatives need to carry out corrective or preventive activities in relation to their medical devices.
This corrective action can be initiated through the establishment post market information such as medical device’s complaints, incident reports and so on. It also includes the field corrective actions taken by the manufacturer to reduce the risk of harm to the patient, the operator or others and/or to reduce the re-occurrence of the incident.