FDA Finalises Advice on Servicing and Remanufacturing Medical Devices

The FDA revised the heading of the final draft guideline and included an article on the legal responsibilities for remanufacturers, almost three years after issuing the draft guideline.

In 2021, the FDA released draft guidelines that elucidated the differences between the service and remanufacturing of devices. A lot of recyclable healthcare equipment is maintained. It was not obvious in the past when performing a service grew substantial enough to be considered remanufacturing.

Remanufacturing was described in the initial version as any action taken on a completed device that materially alters its intended function, security, or effectiveness, including remodelling, repackaging, or item restoration.

The FDA modified several sections of the text but kept the meaning of remanufacturing after reviewing comments on the draft. The material is now explicitly stated in the revised headline to apply to “entities that perform servicing or remanufacturing,” and an addition in the guidance’s body reflects this change in focus.

The FDA’s Centre for Devices and Radiological Health director, Jeff Shuren, spoke on how organisations wishing to preserve devices may benefit from defining what constitutes (a) service and remanufacturing.

“This guidance provides important clarity on defining remanufacturing and helps to remove perceived barriers to obtaining repair or maintenance of a device if it does not alter the safety, performance or intended use,” He explained.