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 athttp://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 toDSMICA@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.
Related Questions
- If we report to MedSun, do we still have to report adverse medical device events to FDA and manufacturers on MedWatch Form 3500A?
- Where can I find the reporting codes for adverse events that I use with medical device reports?
- What responsibilities does my office practice have for reporting medical device adverse events?
