CFR section
21 CFR 803.20(a)(2): How do I complete and submit an individual adverse event report?
PART 803-MEDICAL DEVICE REPORTING · Subpart B-Generally Applicable Requirements for Individual Adverse Event Reports
Key facts
| Citation | 21 CFR 803.20(a)(2) |
|---|---|
| Section | How do I complete and submit an individual adverse event report? |
| Part | PART 803-MEDICAL DEVICE REPORTING |
| Subpart | Subpart B-Generally Applicable Requirements for Individual Adverse Event Reports |
| Subchapter | 21 CFR H Medical Devices |
| Product types cited | Devices |
| Regulation text (excerpt) | (2) To submit a mandatory report in written form, a user facility must use Form FDA 3500A. |
At a glance
- 1–9 Inspections citing this section
- 1–9 Warning letters citing this section
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About CFR sections cited by the FDA
Title 21 of the Code of Federal Regulations contains the FDA's regulations, including current good manufacturing practice and quality system requirements that inspections cite.