MedWatch

What is MedWatch?

MedWatch is the FDA's umbrella program for clinical safety reporting and safety communication across regulated medical products, including devices. It receives voluntary reports and publishes safety alerts, so it operates in both directions: information flowing to the FDA, and FDA safety communications flowing back to clinicians and the public.

What are Form 3500 and Form 3500A?

Form 3500 is the voluntary report used by health professionals, consumers and patients. Form 3500A is the mandatory reporting form used by manufacturers, importers and device user facilities submitting under the medical device reporting regulation; its device reports flow into the public MAUDE database. A third variant, 3500B, gives consumers a plain-language format.

How does MedWatch affect device manufacturers?

Voluntary reports about a company's device can arrive through MedWatch without the company's involvement, and complaint-handling procedures should account for events the manufacturer first learns about from the FDA rather than from customers. MedWatch safety alerts about competitor devices or a device category are also inputs to risk management: a hazard the FDA has publicized for a category is difficult to argue was unforeseeable for your own device.

Is MedWatch only for devices?

No — it spans drugs, biologics, combination products, dietary supplements and cosmetics, which matters for combination products whose adverse events may implicate either constituent. Device-specific mandatory reporting duties, timelines and forms remain governed by 21 CFR Part 803, and companies operating in the United States usually document both the mandatory and the voluntary-channel workflows in one procedure.