 |
Code of Federal Regulations (Last Updated: November 8, 2024) |
 |
Title 21 - Food and Drugs |
|
|
Chapter I - Food and Drug Administration, Department of Health and Human Services |
|
|
SubChapter H - Medical Devices |
|
|
Part 803 - Medical Device Reporting |
|
|
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? |