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# FDA Seeks Comments on Device Corrections/Removals
- URL: https://www.fdaweb.com/fda-seeks-comments-on-device-corrections-removals/
- Published: 2017-06-27T12:00:00.000Z
- Updated: 2026-09-14T22:31:55.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5139030

*Federal Register* notice: FDA is seeking comments on an information collection extension for “Medical Devices; Reports of Corrections and Removals — 21 CFR Part 806 OMB Control Number 0910–0359.” Under 21 CFR 806.10, device makers must report to FDA within 10 working days any action to correct or remove a device to reduce a risk to health posed by the device or to remedy a violation caused by the device that may present a risk to health. Additionally, device makers or importers that initiate a correction or removal that is not required to be reported to FDA must keep a record of the correction or removal. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2017-06-26/pdf/2017-13248.pdf?ref=fdaweb.com).