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.