Manufacturer Reporting Requirements | Midpage

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Code of Federal Regulations

Subpart E

Manufacturer Reporting Requirements

803.50If I am a manufacturer, what reporting requirements apply to me?803.52If I am a manufacturer, what information must I submit in my individual adverse event reports?803.53If I am a manufacturer, in which circumstances must I submit a 5-day report?803.56If I am a manufacturer, in what circumstances must I submit a supplemental or followup report and what are the requirements for such reports?803.58Foreign manufacturers.