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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

  1. Determine if an event is reportable under mandatory MDR rules vs voluntary MedWatch.
  2. Collect device identifiers and clinical details.
  3. Submit via appropriate FDA channels and archive evidence.

EXAMPLES

  • A hospital voluntarily reports a near-miss device malfunction via MedWatch.

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SOURCES

Track regulatory signals related to MedWatch across 27 authorities in real time.

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