CFR section
21 CFR 806.10(d): 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(d) |
|---|---|
| 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) | (d) If, after submitting a report under this part, a manufacturer or importer determines that the same correction or removal should be extended to additional lots or batches of the same device, the manufacturer or importer shall within 10-working days of initiating the extension of the correction or removal, amend the report by submitting an amendment citing the original report number assigned according to paragraph (c)(1) of this section, all of the information required by paragraph (c)(2), and… |
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