MedWatch Voluntary Reporting Form

What to Report to FDA MedWatch:

Use the MedWatch form to report adverse events that you observe or suspect for human medical products, including serious drug side effects, product use/medication error, product quality problems, and therapeutic failures for:

• Prescription or over-the-counter medicines, as well as medicines administered to hospital patients or at outpatient infusion centers
• Biologics (including blood components, blood and plasma derivatives, allergenic, human cells, tissues, and cellular and tissue-based products (HCT/Ps))
• Medical devices (including in vitro diagnostic products)
• Combination products
• Special nutritional products (infant formulas, and medical foods)
• Cosmetics
• Foods/beverages (including reports of serious allergic reactions)

What Not to Report to FDA MedWatch:

• Tobacco: Tobacco product problems should be reported to the Safety Reporting Portal
• Vaccines: Report vaccine events to the Vaccine Adverse Event Reporting System (VAERS) online at https://vaers.hhs.gov/reportevent.html
• Investigational (study) drugs: Report investigational (study) drug adverse events as required in the study protocol and send to the address and contact person listed in the study protocol.
• Mandatory reporting by regulated industry:
  
  • Drugs and Biologics
  • Applicable Regulations
  • Devices
• Reporting on Dietary Supplements
• Reporting on Veterinary Medicine Products
• Reports FDA Does Not Handle (e.g. CPSC, FTC, State Health Departments) and Where to Send Them