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U.S. Department of Health and Human Services

Safety

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Referencing FDA's MedWatch Program

 

The following standard text is recommended to describe how to submit post-market voluntary reports to FDA for human medical products.

 

Program Name


MedWatch logo

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

 

How to Report - General


Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178


 

 

How to Report - Dear Healthcare Professional Letters, Recall Notices or other communications targeted to healthcare professionals:


Adverse events, product quality problems, product use errors, or reports of therapeutic inequivalence/failure should be reported to FDA's MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178