MedWatch is FDA's medical-product safety reporting programme for healthcare professionals, patients and consumers and is also a central route to FDA safety information.
Core official resources
- MedWatch — reporting and safety-information hub.
- MedWatch forms — Forms 3500, 3500B and information on Form 3500A.
Important distinction
MedWatch should not be treated as synonymous with the entire FDA mandatory industry reporting architecture. FDA notes that Form 3500A is used for mandatory reporting only where electronic submission is not required; product-specific electronic reporting obligations and systems must therefore be checked separately.