[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: 21CFR803.21]



[Page 48]

 

                        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/

373.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: 301-443-8818, 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.