On May 10, 2024, the FDA issued a guidance document on “Remanufacturing of Medical Devices.” Remanufacturing is the processing, conditioning, renovating, repackaging, restoring, or any other act done to a finished device that significantly changes the finished device’s performance or safety specifications, or intended use. The document is intended help clarify whether activities performed on devices are likely to be considered “remanufacturing” in an effort to provide consistency and a better understanding of applicable statutory and regulatory requirements. Also included are recommendations for information that should be included on labeling to help ensure the continued quality, safety, and effectiveness of devices that are intended to be serviced over their useful life.
The document addresses activities performed on devices that are intended to be reused and maintained, discussing whether activities performed by original equipment manufacturers (OEMs) and third parties on such devices are likely considered as remanufacturing. Contrarily, the guidance is not intended to adopt significant policy changes, but to clarify FDA’s current thinking on applicable definitions, while not changing the regulatory requirements applicable to remanufacturers.
Read the full guidance here.
