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Generally Applicable Requirements for Individual Adverse Event Reports
Law
CFR 21
Food and Drugs
Food and Drug Administration, Department of Health and Human Services
Medical Devices
Medical Device Reporting
Generally Applicable Requirements for Individual Adverse Event Reports
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Section
803.20
How do I complete and submit an individual adverse event report?
Section
803.21
Where can I find the reporting codes for adverse events that I use with medical device reports?
Section
803.22
What are the circumstances in which I am not required to file a report?
Section
803.23
Where can I find information on how to prepare and submit an MDR in electronic format?