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KATEGORIE: SAFETY SURVEILLANCE
Sicherheitskorrekturmaßnahme im Feld (FSCA)
Eine vom Hersteller ergriffene Maßnahme zur Verringerung eines Risikos im Zusammenhang mit einem bereits auf dem Markt befindlichen Produkt.
Last reviewed 2026-08-05 · Reviewed by MedFlux Editorial Board · Editorial policy
Expanded process notes below are currently maintained in English; the short definition above is localized. See our 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 Sicherheitskorrekturmaßnahme im Feld (FSCA) across 27 authorities in real time.
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