CFR 21-803.21-2014
Food and Drugs. Part803:Medical device reporting (Eff. 8-14-15). Section803.21:Where can I find the reporting codes for adverse events that I use with medical device reports?

Standard No.

CFR 21-803.21-2014

Release Date

2014

Published By

US-CFR-file

Latest

CFR 21-803.21-2014

Scope

(a) The MedWatch Medical Device Reporting Code Instruction Manual contains adverse event codes for use with Form FDA 3500A. You may obtain the coding manual from FDA's Web site at: http://www.fda.gov/ MedicalDevices/Safety/ReportaProblem/ FormsandInstruc

CFR 21-803.21-2014 history

• 2014 CFR 21-803.21-2014 Food and Drugs. Part803:Medical device reporting (Eff. 8-14-15). Section803.21:Where can I find the reporting codes for adverse events that I use with medical device reports?