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Generally Applicable Requirements for Individual Adverse Event Reports | Midpage
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Code of Federal Regulations
Title 21
Chapter I
Subchapter H
Part 803
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?