CFR section
21 CFR 806.20(c): 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(c) |
|---|---|
| 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) | (c) The manufacturer or importer shall retain records required under this section for a period of 2 years beyond the expected life of the device, even if the manufacturer or importer has ceased to manufacture or import the device. Records required to be maintained under paragraph (b) of this section must be transferred to the new manufacturer or importer of the device and maintained for the required period of time. |
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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.