CFR section
21 CFR 803.50(a)(2): 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)(2) |
|---|---|
| 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 | Biologics, Devices, Drugs, General, Other_Regulations |
| Regulation text (excerpt) | (2) Has malfunctioned and this device or a similar device that you market would be likely to cause or contribute to a death or serious injury, if the malfunction were to recur. |
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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.