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类别: SAFETY SURVEILLANCE
现场安全纠正措施(FSCA)
制造商为降低与已上市器械相关的死亡或健康严重恶化风险而采取的行动。FSCA包括器械召回、修改、使用建议和软件更新。
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 现场安全纠正措施(FSCA) across 27 authorities in real time.
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