Who is required by FDA to report adverse events through MedWatch?

• A. Health care professionals
• B. Manufacturers
• C. Consumers
• D. Hospitals

Answer: (B)

Adverse event reporting to MedWatch is a regulatory duty placed on manufacturers and importers of FDA-regulated products. They must report serious and unexpected adverse reactions and other safety problems they receive or learn about, so FDA can quickly detect safety signals and take appropriate action, such as updating labeling or removing a product from the market. This obligation is what makes manufacturers the correct answer.

Clinicians and consumers can submit MedWatch reports, but those reports are typically voluntary rather than mandatory. Hospitals may gather safety information and report through the manufacturer or directly to MedWatch, but the legal requirement to report lies with the manufacturers.