Subpart B—Generally Applicable Requirements for Individual Adverse Event Reports
Sections
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803.20
§ 803.20 How do I complete and submit an individual adverse event report? -
803.21
§ 803.21 Where can I find the reporting codes for adverse events that I use with medical device reports? -
803.22
§ 803.22 What are the circumstances in which I am not required to file a report? -
803.23
§ 803.23 Where can I find information on how to prepare and submit an MDR in electronic format?