CFR section
21 CFR 806.20(b)(2): Records of corrections and removals not required to be reported
PART 806-MEDICAL DEVICES; REPORTS OF CORRECTIONS AND REMOVALS · Subpart B-Reports and Records
Key facts
| Citation | 21 CFR 806.20(b)(2) |
|---|---|
| Section | Records of corrections and removals not required to be reported |
| Part | PART 806-MEDICAL DEVICES; REPORTS OF CORRECTIONS AND REMOVALS |
| Subpart | Subpart B-Reports and Records |
| Subchapter | 21 CFR H Medical Devices |
| Product types cited | Devices |
| Regulation text (excerpt) | (2) The unique device identifier (UDI) of the device, or the device identifier, universal product code (UPC), model, catalog, or code number of the device and the manufacturing lot or serial number of the device or other identification number. |
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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.