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?