MedWatch

Key facts

Run by

U.S. Food and Drug Administration

Launched

1993

Voluntary forms

Form FDA 3500 (health professionals), Form FDA 3500B (consumers)

Mandatory form

Form FDA 3500A, for manufacturers, user facilities and other required reporters

Not covered

Vaccines, which are reported to VAERS

What is MedWatch?

MedWatch is the main channel for reporting safety problems with medical products to the Food and Drug Administration (FDA). Health care professionals, patients and caregivers can submit voluntary reports online or on paper, and companies and certain facilities use MedWatch formats for reports the law requires.

The program also works in the other direction. MedWatch safety alerts distribute FDA information about recalls, labeling changes, Drug Safety Communications and other safety notices to health professionals and the public.

MedWatch is a reporting channel, not the database itself. Reports are routed into product-specific systems, so analysts query the FDA Adverse Event Reporting System (FAERS) for drugs and biologics and the MAUDE database for devices.

How MedWatch reporting works

Different forms serve different reporters:

Products covered include prescription and over-the-counter drugs, biologics other than vaccines, medical devices, combination products, dietary supplements, infant formula and cosmetics. Drug manufacturers now submit most individual case safety reports electronically in the ICH E2B format rather than on paper forms.

• Form FDA 3500: voluntary reports from health care professionals.
• Form FDA 3500B: a plain-language voluntary form for consumers and patients.
• Form FDA 3500A: mandatory reports from manufacturers, importers, device user facilities such as hospitals and nursing homes, and other required reporters.

Why MedWatch matters

MedWatch sits at both ends of the product safety information flow:

• Voluntary reports from clinicians and patients are a main source of early safety signals for marketed products.
• Pharmacy, hospital and compliance teams subscribe to MedWatch safety alerts to act quickly on recalls and safety communications affecting products they stock.
• Pharmacovigilance and quality teams must route events correctly, since manufacturers that learn of adverse events from any source have their own reporting obligations.
• Researchers and journalists who see a MedWatch report cited should look for the coded data in FAERS or MAUDE, where reports can be counted and compared.

Common misconceptions about MedWatch

A MedWatch report is a notice that a product may be involved in a problem, not a finding. FDA does not confirm each report, and a report does not establish that the product caused the event.

MedWatch safety alerts are also not a complete list of recalls. Most recalls appear only in the weekly FDA Enforcement Report.