CFR section
21 CFR 803.52(b)(2): 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)(2) |
|---|---|
| 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) | (2) Outcomes attributed to the adverse event (e.g., death or serious injury). An outcome is considered a serious injury if it is: (i) A life-threatening injury or illness; (ii) A disability resulting in permanent impairment of a body function or permanent damage to a body structure; or (iii) An injury or illness that requires intervention to prevent permanent impairment of a body structure or function; |
At a glance
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- 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.