[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR803.21]

[Page 54]
 
                        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 B_Generally Applicable Requirements for Individual Adverse Event 
                                 Reports
 
Sec. 803.21  Where can I find the reporting codes for adverse events
that I use with medical device reports?

    (a) The MEDWATCH Medical Device Reporting Code Instruction Manual 
contains adverse event codes for use with FDA Form 3500A. You may obtain 
the coding manual from CDRH's Web site at http://www.fda.gov/cdrh/mdr/
mdr-forms.html; and from the Division of Small Manufacturers, 
International, and Consumer Assistance, Center for Devices and 
Radiological Health, 1350 Piccard Dr., Rockville, MD 20850, FAX: 240-
276-3151, or e-mail to DSMICA@CDRH.FDA.GOV.
    (b) We may sometimes use additional coding of information on the 
reporting forms or modify the existing codes. If we do make 
modifications, we will ensure that we make the new coding information 
available to all reporters.

[70 FR 9519, July 13, 2005, as amended at 72 FR 17399, Apr. 9, 2007]