CFR section
21 CFR 803.52(b)(5): If I am a manufacturer, what information must I submit in my individual adverse event reports?
PART 803-MEDICAL DEVICE REPORTING · Subpart E-Manufacturer Reporting Requirements
Key facts
| Citation | 21 CFR 803.52(b)(5) |
|---|---|
| Section | If I am a manufacturer, what information must I submit in my individual adverse event reports? |
| Part | PART 803-MEDICAL DEVICE REPORTING |
| Subpart | Subpart E-Manufacturer Reporting Requirements |
| Subchapter | 21 CFR H Medical Devices |
| Product types cited | Devices |
| Regulation text (excerpt) | (5) Description of the event or problem, including a discussion of how the device was involved, nature of the problem, patient followup or required treatment, and any environmental conditions that may have influenced the event; |
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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.