Title 21

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.

21:8.0.1.1.3.2.1.1	SECTION 803.20	803.20 How do I complete and submit an individual adverse event report
21:8.0.1.1.3.2.1.2	SECTION 803.21	803.21 Where can I find the reporting codes for adverse events that I use with medical device reports
21:8.0.1.1.3.2.1.3	SECTION 803.22	803.22 What are the circumstances in which I am not required to file a report
21:8.0.1.1.3.2.1.4	SECTION 803.23	803.23 Where can I find information on how to prepare and submit an MDR in electronic format

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