(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 athttp://www.fda.gov/Safety/MedWatch/HowToReport/DownloadForms/ucm149238.htm .
(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; 75 FR 20914, Apr. 22, 2010]