Subpart E - MANUFACTURER REPORTING REQUIREMENTS
- Section 803.50 - If I am a manufacturer, what reporting requirements apply to me?
- Section 803.52 - If I am a manufacturer, what information must I submit in my individual adverse event reports?
- Section 803.53 - If I am a manufacturer, in which circumstances must I submit a 5-day report?
- Section 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?
- Section 803.58 - Foreign manufacturers