21 CFR Subpart B
Generally Applicable Requirements for Individual Adverse Event Reports
June 25, 2020
§
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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