MedWatch Adverse Event Reporting Program

thru: United States Department of Health and Human Services Food and Drug Administration

• Receives reports from the public for FDA-regulated products such as:

Prescription and over-the-counter medicines.
Biologics such as blood components, blood/plasma derivatives and gene therapies.
Medical devices such as hearing aids breast pumps, and pacemakers.
Combination products such as pre-filled drug syringe, metered-dose inhalers and nasal spray.
Special nutritional products such as dietary supplements, medical foods and infant formulas.
Cosmetics such as moisturizers, makeup, shampoos, hair dyes and tattoos.
Food such as beverages and ingredients added to foods.

Eligibility: None.

Application Process: Fill out the MedWatch Online Voluntary Reporting Form and submit here: https://www.accessdata.fda.gov/scripts/medwatch/index.cfm

Required Documentation: Reporting form. Call or visit website for more information.

Fees: No fee for services.

Coverage Note: United States.