§ 803.21. Where can I find the reporting codes for adverse events that I use with medical device reports?
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/us/cfr/t21/s§ 803.21·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(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. [79 FR 8846, Feb. 14, 2014, as amended at 85 FR 18441, Apr. 2, 2020]