Code of Federal Regulations · Subpart

Subpart A — General Provisions

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

• § 803.1 What Does This Part Cover?
• § 803.3 How Does Fda Define The Terms Used In This Part?
• § 803.9 What Information From The Reports Do We Disclose To The Public?
• § 803.10 Generally, What Are The Reporting Requirements That Apply To Me?
• § 803.11 What Form Should I Use To Submit Reports Of Individual Adverse Events And Where Do I Obtain These Forms?
• § 803.12 How Do I Submit Initial And Supplemental Or Followup Reports?
• § 803.13 Do I Need To Submit Reports In English?
• § 803.15 How Will I Know If You Require More Information About My Medical Device Report?
• § 803.16 When I Submit A Report, Does The Information In My Report Constitute An Admission That The Device Caused Or Contributed To The Reportable Event?
• § 803.17 What Are The Requirements For Developing, Maintaining, And Implementing Written Mdr Procedures That Apply To Me?
• § 803.18 What Are The Requirements For Establishing And Maintaining Mdr Files Or Records That Apply To Me?
• § 803.19 Are There Exemptions, Variances, Or Alternative Forms Of Adverse Event Reporting Requirements?