Compliance
MedWatch
TL;DR
FDA's voluntary adverse-event and product-problem reporting system for healthcare professionals, patients and consumers (Form 3500).
MedWatch is the FDA programme through which clinicians, patients and consumers voluntarily report adverse events, product-quality problems, therapeutic failures and medication errors involving FDA-regulated drugs, biologics, devices, cosmetics and dietary supplements. Form FDA 3500 (voluntary) is distinct from Form FDA 3500A (mandatory, used by manufacturers under 21 CFR 803 / 314.80 / 600.80).
MedWatch signals feed FDA's pharmacovigilance and post-market device surveillance and can trigger Safety Communications, recalls or Warning Letters.
Regulatory anchors
- FDA Form 3500 / 3500A
- 21 CFR 803
- 21 CFR 314.80
Industries that live with this
Related terms
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