How to Report SUSARs to FDA

The U.S. Food and Drug Administration's MedWatch handles suspected unexpected serious adverse reactions to FDA-regulated drugs, biologics, medical devices, dietary supplements or cosmetics. Adverse reactions include death, life-threatening events, hospitalization (initial or prolonged), disability or events requiring intervention to prevent permanent damage. Investigators and others can make reports online, or by phone, fax or mail.

Things You'll Need

• Form FDA 3500

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Instructions

• 1

  Go to https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm. This is MedWatch’s online voluntary reporting form – the same as the downloadable Form FDA 3500. Health care professionals, consumers and patients use that form to report suspected unexpected serious adverse reactions, known as SUSARs. Click the begin button, follow the instructions and answer all questions. Click on submit when you have filled in all the required information.

• 2

  Call [phone] if you want to report the incident via phone. Speak to the operator and answer all hisr questions regarding the SUSAR. Before the call, download Form FDA 3500 so you know what information the Food and Drug Administration requires. You can go to http://www.fda.gov/Safety/MedWatch/HowToReport/DownloadForms/default.htm.

• 3

  Go to http://www.fda.gov/Safety/MedWatch/HowToReport/DownloadForms/default.htm and download Form FDA 3500, if you want to fax or mail the report. Print out the form and fill-in all necessary details.

  The download forms site is also where manufacturers, distributors, importers and facilities personne--who are required to report SUSARs--go to download Form FDA 3500A, the mandatory reporting form.

• 4

  Fax Page 1 and any continuation pages of either Form FDA 3500 or 3500A to 1-800-332-0178. Do not fax the instruction pages.

• 5

  Enclose Page 1 and any continuation pages of Form FDA 3500 or 3500A in an envelope. You do not need to worry about postage as both forms come with a postage-paid insignia that you affix to the envelope. Mail it to: MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787.