[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2001]
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  Reporting codes.

    (a) FDA has developed a MEDWATCH Mandatory Reporting Form Coding 
Manual for use with medical device reports. This manual contains codes 
for hundreds of adverse events for use with FDA Form 3500A. The coding 
manual is available from the Division of Small Manufacturer Assistance, 
Center for Devices and Radiological Health, 1350 Piccard Dr., Rockville, 
MD 20850, FAX 301-443-8818.
    (b) FDA may use additional coding of information on the reporting 
forms or modify the existing codes on an ad hoc or generic basis. In 
such cases, FDA will ensure that the new coding information is available 
to all reporters.