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# Comments Extended on Device Remanufacturing Guide
- URL: https://www.fdaweb.com/comments-extended-on-device-remanufacturing-guide/
- Published: 2021-08-04T12:00:00.000Z
- Updated: 2026-09-14T17:09:11.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5149862

*Federal Register* notice: FDA is extending the comment period for a 6/24 notice on a draft guidance entitled *Remanufacturing of Medical Devices*. Comments can now be submitted until 9/22\. The guidance is intended to help clarify whether activities performed on devices are likely “remanufacturing.” The [document](https://www.fda.gov/media/150141/download?ref=fdaweb.com) says such clarification is intended to help provide consistency and better understanding of applicable statutory and regulatory requirements. The draft also includes recommendations for information that should be included in labeling to help assure the continued quality, safety, and effectiveness of devices that are intended to be serviced over their useful life. To view the notice, click [here](https://public-inspection.federalregister.gov/2021-16695.pdf?ref=fdaweb.com).