Per the notice below, the United States Food and Drug Administration (FDA) has issued final guidance on the difference between remanufacturing a medical/dental device and maintenance and repair of such devices.

FDA Issues Final Guidance on Remanufacturing of Medical Devices

On May 9, 2024, the U.S. Food and Drug Administration (FDA) issued Final Guidance: Remanufacturing of Medical Devices as part of its ongoing efforts to help explain the difference between remanufacturing and servicing.  This guidance clarifies whether activities performed on devices are likely remanufacturing, which is different than servicing activities such as maintenance and repair.  This clarification is intended to help ensure consistency and a better understanding of the regulatory requirements applicable to remanufacturers.

Upcoming Webinar on this guidance

On September 10, 2024, the FDA will host a webinar for those interested in learning more about the final guidance.

Questions?

If you have questions about this final guidance, contact the Division of Industry and Consumer Education.