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類別: SAFETY SURVEILLANCE

AEMS（不良事件監測系統）

FDA於2026年3月推出的統一不良事件平台，取代MAUDE、FAERS、VAERS等7個舊系統。AEMS在單一儀表板中為所有FDA監管產品提供即時報告。

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

AEMS is FDA’s 2026 unified adverse event platform consolidating legacy systems including MAUDE for devices. RA/quality teams should plan monitoring workflows for the transition.

PROCESS / STEPS

  1. Map current MAUDE/openFDA queries to AEMS capabilities as published.
  2. Update SOPs for searching and archiving AE evidence.
  3. Train teams on timelines and API changes.
  4. Keep dual-monitoring during transition windows.

EXAMPLES

  • Cross-product signals (drug-device) are a stated goal of unified surveillance.

RELATED GUIDES & TOOLS

SOURCES

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相關術語

MAUDE資料庫不良事件MedWatch