Guidelines for Device Remanufacturing

• Programs that engage in remanufacturing could be subject to the FDA regulations.

• Because of the complexities involved in remanufacturing, we encourage AT reutilization programs to avoid remanufacturing.

• If a program chooses to remanufacture, it will be critical to identify and comply with the FDA regulations for remanufacturers, including registration, device listing, premarket notification or approval, labeling, quality system regulation, and reporting.