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CATEGORY: SAFETY SURVEILLANCE
Field Safety Corrective Action (FSCA)
An action taken by the manufacturer to reduce a risk of death or serious deterioration of health associated with a device already on the market. FSCAs include device recalls, modifications, advice on use, and software updates.
Last reviewed 2026-08-05 · Reviewed by MedFlux Editorial Board · Editorial policy
WHEN IT APPLIES
A Field Safety Corrective Action reduces risk for devices already on the market—recalls, software patches, advice to users—often paired with Field Safety Notices in the EU.
PROCESS / STEPS
- Assess risk and decide action type.
- Notify authorities/NB as required; communicate to customers.
- Implement corrections; verify effectiveness.
- Update PMS/risk documentation.
EXAMPLES
- A cybersecurity patch distributed as FSCA with user instructions.
RELATED GUIDES & TOOLS
SOURCES
Track regulatory signals related to Field Safety Corrective Action (FSCA) across 27 authorities in real time.
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