SUBPART E—Manufacturer Reporting Requirements (§803.50 to §803.58)
- 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.