[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR803.11]

[Page 49]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 803_MEDICAL DEVICE REPORTING--Table of Contents
 
                      Subpart A_General Provisions
 
Sec.  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 Sec.  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: DSMICA@CDRH.FDA.GOV, or FAX: 
301-443-8818; or
    (4) On the Internet at http://www.fda.gov/cdrh/mdr/mdr-forms.html.