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U.S. Code of Federal Regulations
Regulations most recently checked for updates: Aug 28, 2025
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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?
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