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CATÉGORIE: SAFETY SURVEILLANCE
MedWatch
Le programme FDA d'information sur la sécurité et de signalement des événements indésirables, permettant de signaler des problèmes graves avec les dispositifs médicaux.
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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