Federal (United States) · Regulations
Subpart E — Manufacturer Reporting Requirements
5 sections
5 sections
- 21 C.F.R. § 803.50If I am a manufacturer, what reporting requirements apply to me?
- 21 C.F.R. § 803.52If I am a manufacturer, what information must I submit in my individual adverse event reports?
- 21 C.F.R. § 803.53If I am a manufacturer, in which circumstances must I submit a 5-day report?
- 21 C.F.R. § 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?
- 21 C.F.R. § 803.58Foreign manufacturers.