PART 803 SUBPART B
Subpart B - Generally Applicable Requirements for Individual Adverse Event Reports
- 21 U.S.C. 352, 360, 360i, 360j, 371, 374.
- 79 FR 8846, Feb. 14, 2014, unless otherwise noted.
|21:18.104.22.168.22.214.171.124||SECTION 803.20||803.20 How do I complete and submit an individual adverse event report|
|21:126.96.36.199.188.8.131.52||SECTION 803.21||803.21 Where can I find the reporting codes for adverse events that I use with medical device reports|
|21:184.108.40.206.220.127.116.11||SECTION 803.22||803.22 What are the circumstances in which I am not required to file a report|
|21:18.104.22.168.22.214.171.124||SECTION 803.23||803.23 Where can I find information on how to prepare and submit an MDR in electronic format|