CFR

803.11—What form should I use to submit reports of individual adverse events and where do I obtain these forms?

If you are a user facility, importer, or manufacturer, you must submit all reports of individual adverse events on FDA MEDWATCH Form 3500A or in an electronic equivalent as approved under § 803.14. You may obtain this form and all other forms referenced in this section from any of the following:

(a) The Consolidated Forms and Publications Office, Beltsville Service Center, 6351 Ammendale Rd., Landover, MD 20705;

(b) FDA, MEDWATCH (HF-2), 5600 Fishers Lane, Rockville, MD 20857, 301-827-7240;

(c) Food and Drug Administration, Center for Devices and Radiological Health, Division of Small Manufacturers, International and Consumer Assistance, 10903 New Hampshire Ave., Bldg. 66, rm. 4521, Silver Spring, MD 20993-0002.

(d) On the Internet at http://www.fda.gov/medwatch/getforms.htm.

Code of Federal Regulations

[72 FR 17399, Apr. 9, 2007, as amended at 75 FR 20914, Apr. 22, 2010]

Tips