Code of Federal Regulations · Subpart

Subpart E — Manufacturer Reporting Requirements

21 C.F.R. pt. 803, subpt. E

• § 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