Subpart E—Manufacturer Reporting Requirements

1. CFR
2. ›
3. Title 21
4. ›
5. Chapter I
6. ›
7. Part 803
8. ›
9. Subpart E

Sections

Section numbering in the official eCFR can be non-consecutive. Omitted section numbers are not treated here as reserved unless the source explicitly labels them that way.

• 803.50
  § 803.50 If I am a manufacturer, what reporting requirements apply to me?
• 803.52
  § 803.52 If I am a manufacturer, what information must I submit in my individual adverse event reports?
• 803.53
  § 803.53 If I am a manufacturer, in which circumstances must I submit a 5-day report?
• 803.56
  § 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
  § 803.58 Foreign manufacturers.