21 CFR Part 803, Subpart E - Manufacturer Reporting Requirements
prev | next
- § 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.