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  1. Medical Product Safety Information

MedWatch Forms for FDA Safety Reporting

Voluntary Reporting For use by Health Professionals, Consumers, and Patients

Reporting can be done through our online reporting portal or by downloading, completing and then submitting FDA Form 3500 (health professional) or 3500B (consumer/patient) to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.

Where to Report Other FDA Regulated Product Safety Information

Other products that the FDA regulates include Tobacco Products, Vaccines, and Animal Drugs, Devices and Food, including Pet Food. These products utilize different reporting pathways. It is recommended that reports concerning these products be submitted directly to the appropriate portals below.

  • Tobacco, E-cigarettes or Vaping: Report problems or adverse health events and tobacco product problems to include problems with e-cigarettes (also known as “vapes”), e-liquids, heated tobacco products, cigarettes, roll-your-own cigarettes, cigars, little cigars, pipes, waterpipes (also known as hookah), chewing tobacco, snuff, or snus. Report issues to the Safety Reporting Portal.
  • Vaccines: Report vaccine events to the Vaccine Adverse Event Reporting System (VAERS).
  • Animal Drug, Device, Pet Food and Livestock Feed Problems: Report a Problem to the Center for Veterinary Medicine. 

Note that submissions for these products through MedWatch will be accepted and directed to the correct.

Resources For You

MedWatch Safety Information

Clinically important medical product safety alerts and timely information about the products you use, prescribe, or dispense every day.

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