CFR section
21 CFR 806.10(c)(4): Reports of corrections and removals
PART 806-MEDICAL DEVICES; REPORTS OF CORRECTIONS AND REMOVALS · Subpart B-Reports and Records
Key facts
| Citation | 21 CFR 806.10(c)(4) |
|---|---|
| Section | Reports of corrections and removals |
| 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) | (4) Marketing status of the device, i.e., any applicable premarket notification number, premarket approval number, or indication that the device is a preamendments device, and the device listing number. A manufacturer or importer that does not have an FDA establishment registration number shall indicate in the report whether it has ever registered with FDA. |
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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.