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類別: SAFETY SURVEILLANCE
MedWatch
FDA安全資訊和不良事件報告計畫。MedWatch允許醫療專業人員、消費者和製造商報告醫療器材、藥品和其他FDA監管產品的嚴重問題。
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
MedWatch is FDA’s safety reporting program for professionals and consumers to report serious problems with devices, drugs, and other regulated products; manufacturer MDR obligations remain distinct.
PROCESS / STEPS
- Determine if an event is reportable under mandatory MDR rules vs voluntary MedWatch.
- Collect device identifiers and clinical details.
- Submit via appropriate FDA channels and archive evidence.
EXAMPLES
- A hospital voluntarily reports a near-miss device malfunction via MedWatch.
RELATED GUIDES & TOOLS
SOURCES
Track regulatory signals related to MedWatch across 27 authorities in real time.
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