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CATEGORY: SAFETY SURVEILLANCE
MedWatch
The FDA Safety Information and Adverse Event Reporting Program. MedWatch allows healthcare professionals, consumers, and manufacturers to report serious problems with medical devices, drugs, and other FDA-regulated products.
Last reviewed 2026-08-05 · Reviewed by MedFlux Editorial Board · 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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