Reporting Serious Problems to FDA
Thank you for visiting the MedWatch Web site to voluntarily report a serious adverse event, product quality problem, product use error, or therapeutic inequivalence/failure that you suspect is associated with the use of an FDA-regulated drug, biologic, medical device, dietary supplement or cosmetic. You can also report suspected counterfeit medical products to FDA through MedWatch.
In order to keep effective medical products available on the market, the FDA relies on the voluntary reporting of these events. FDA uses these data to maintain our safety surveillance of these products. Your report may be the critical action that prompts a modification in use or design of the product, improves its safety profile and leads to increased patient safety.
If the link to the PDF voluntary reporting form (below) does not automatically open the form in your browser, try installing the latest version of the free Adobe Acrobat Reader.
Voluntary Reporting for Consumers and Healthcare Professionals
- Report a Serious Medical Product Problem Online
Report product quality problems, adverse reactions, product use errors, or therapeutic failure.
- Online Dietary Supplement Problem Reporting
- Online Tobacco Product Problem Reporting
When consumers or health care providers suspect a problem with a tobacco product they can now use the Department of Health and Human Services’ Safety Reporting Portal (SRP).
- Consumer-Friendly Voluntary Reporting Form (PDF - 1.2MB)
- Health Professional Voluntary Reporting Form (PDF - 1.6MB)
- Information on Reporting by Consumers
- Information on Reporting By Health Professionals
Teaching students, health professionals, and consumers how to report problems to FDA
Form FDA 3500A is a two-sided form. It is for use by user facilities, distributors, importers, applicants, and manufacturers for MANDATORY reporting of adverse events and product problems as designated in the applicable statutes and FDA regulations.
If the link to the PDF mandatory reporting form (below) does not automatically open the form in your browser, try installing the latest version of the free Adobe Acrobat Reader.
Mandatory Reporting for Regulated Industry and User Facilities
- Form FDA 3500A Mandatory Reporting (PDF - 1.3MB)
- Form FDA 3500A Instructions (PDF - 217KB)
Where to Send Completed Form FDA 3500A MANDATORY Reporting Form Contact Information for Questions About MANDATORY Reporting Medical Device Reporting (MDR) OTC Products and Dietary Supplements Drug/Biologic/Human Cell, Tissues and Cellular and Tissue-Based Product Manufacturers, Distributors, and Packers Human Cell & Tissue Products (HCT/P) Adverse Reaction Reporting