CFR section
21 CFR 803.50(a)(1): If I am a manufacturer, what reporting requirements apply to me?
PART 803-MEDICAL DEVICE REPORTING · Subpart E-Manufacturer Reporting Requirements
Key facts
| Citation | 21 CFR 803.50(a)(1) |
|---|---|
| Section | If I am a manufacturer, what reporting requirements apply to me? |
| Part | PART 803-MEDICAL DEVICE REPORTING |
| Subpart | Subpart E-Manufacturer Reporting Requirements |
| Subchapter | 21 CFR H Medical Devices |
| Product types cited | Devices, Drugs, General, Other_Regulations |
| Regulation text (excerpt) | (1) May have caused or contributed to a death or serious injury or |
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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.