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