21 CFR 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?