GroundRules
21 CFR 803.21: Where can I find the reporting codes for adverse events that I use with medical device reports?
Where this section sits in the code
- Title 21—Food and Drugs
- CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
- SUBCHAPTER H—MEDICAL DEVICES
- PART 803—MEDICAL DEVICE REPORTING
- Subpart B—Generally Applicable Requirements for Individual Adverse Event Reports
(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 website at: https://www.fda.gov/medical-devices/mandatory-reporting-requirements-manufacturers-importers-and-device-user-facilities/mdr-adverse-event-codes.
(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.
Collected 2026-08-27T02:24:47Z. Source file · JSON