CFR section
21 CFR 803.20(a)(1): 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)(1) |
|---|---|
| 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) | (1) If you are a health professional or consumer or other entity, you may submit voluntary reports to FDA regarding devices or other FDA-regulated products using the Form FDA 3500. |
At a glance
- 1–9 Inspections citing this section
- 1–9 Warning letters citing this section
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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.