CFR section
21 CFR 803.52(f)(9): 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(f)(9) |
|---|---|
| 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) | (9) Whether remedial action was reported as a removal or correction under section 519(f) of the Federal Food, Drug, and Cosmetic Act, and if it was, provide the correction/removal report number; and |
At a glance
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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.