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21 C.F.R. § 803.11   What form should I use to submit reports of individual adverse events and where do I obtain these forms?

Title 21: Food and Drugs
PART 803—MEDICAL DEVICE REPORTING
Subpart A—General Provisions

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§ 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:

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

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

(3) Division of Small Manufacturers, International, and Consumer Assistance, Office of Communication, Education, and Radiation Programs, Center for Devices and Radiological Health (CDRH) (HFZ–220), 1350 Piccard Dr. Rockville, MD 20850, by e-mail: [email protected], or FAX: 301–443–8818; or

(4) On the Internet at http://www.fda.gov/cdrh/mdr/mdr-forms.php.