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# Medical Device Remanufacturing Draft Guidance
- URL: https://www.fdaweb.com/medical-device-remanufacturing-draft-guidance/
- Published: 2021-06-17T12:00:00.000Z
- Updated: 2026-09-14T17:03:55.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5149559

FDA has issued a draft guidance, *Remanufacturing of Medical Devices*, to help clarify whether activities performed on devices are likely “remanufacturing.”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.

The guidance includes Introduction, Background, Scope, Definitions, Guiding Principles. Relevant considerations to determine if activities are remanufacturing, Changes involving software, Considerations for labeling, and two Appendices.