[Code of Federal Regulations]

[Title 21, Volume 8]

[Revised as of April 1, 2006]

From the U.S. Government Printing Office via GPO Access

[CITE: 21CFR803.11]



[Page 44]

 

                        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.