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U.S. Code of Federal Regulations
Regulations most recently checked for updates: Aug 28, 2025
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Title 21
Chapter I
Part 803
Subpart E - Subpart E—Manufacturer Reporting Requirements
§ 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?
§ 803.56 - If I am a manufacturer, in what circumstances must I submit a supplemental or followup report and what are the requirements for such reports?
§ 803.58 - Foreign manufacturers.
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