21 C.F.R. § 803.21 Where can I find the reporting codes for adverse events that I use with medical device reports?
Title 21 - Food and Drugs
(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.php; 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 [email protected]. (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.
Title 21: Food and Drugs
PART 803—MEDICAL DEVICE REPORTING
Subpart B—Generally Applicable Requirements for Individual Adverse Event Reports
§ 803.21 Where can I find the reporting codes for adverse events that I use with medical device reports?
