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e-CFR data is current as of March 5, 2021

Title 21Chapter ISubchapter HPart 803Subpart B → §803.21


Title 21: Food and Drugs
PART 803—MEDICAL DEVICE REPORTING
Subpart B—Generally Applicable Requirements for Individual Adverse Event Reports


§803.21   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 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]

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