Code of Federal Regulations · Subpart

Subpart B — Generally Applicable Requirements For Individual Adverse Event Reports

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

• § 803.20 How Do I Complete And Submit An Individual Adverse Event Report?
• § 803.21 Where Can I Find The Reporting Codes For Adverse Events That I Use With Medical Device Reports?
• § 803.22 What Are The Circumstances In Which I Am Not Required To File A Report?
• § 803.23 Where Can I Find Information On How To Prepare And Submit An Mdr In Electronic Format?