21 CFR Subpart E
Manufacturer Reporting Requirements
June 25, 2020
§
803.56
If I am a manufacturer, in what circumstances must I submit a supplemental or followup report and what are the requirements for such reports?
§
803.50
If I am a manufacturer, what reporting requirements apply to me?
§
803.52
If I am a manufacturer, what information must I submit in my individual adverse event reports?
§
803.53
If I am a manufacturer, in which circumstances must I submit a 5-day report?
§
803.58
Foreign manufacturers
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