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Regulations last checked for updates: May 14, 2025
Title 21 - Food and Drugs last revised: May 12, 2025
All Titles
Title 21
Chapter I
Part 803
Subpart B - Subpart B—Generally Applicable Requirements for Individual Adverse Event Reports
§ 803.20 - How do I complete and submit an individual adverse event report?
§ 803.21 - Where can I find the reporting codes for adverse events that I use with medical device reports?
§ 803.22 - What are the circumstances in which I am not required to file a report?
§ 803.23 - Where can I find information on how to prepare and submit an MDR in electronic format?
authority:
21 U.S.C. 352
,
360
,
360
i,
360
j,
371
,
374
source:
79 FR 8846, Feb. 14, 2014, unless otherwise noted.
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