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.
Link to an amendment published at 80 FR 10587, Feb. 27, 2015.
[72 FR 17399, Apr. 9, 2007, as amended at 75 FR 20914, Apr. 22, 2010]