FDA releases guidance on ‘remanufacturing’ of devices 

WASHINGTON – The U.S. Food and Drug Administration has issued final guidance to provide the medical device industry clarity on the definition of “remanufacturing” for reusable devices needing maintenance or repair. The final guidance was issued following the agency’s extensive review of post-market information and consideration of public comments, which highlighted the need for clarity, considering the different regulatory implications between “servicing” and “remanufacturing” of a medical device.  “Today’s action represents an important step forward in our mission to assure continued patient access to high-quality, safe and effective medical devices,” said Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. “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.” The final guidance sets forth guiding principles that the FDA recommends applying in the context of remanufacturing, a flowchart to help determine whether activities may be remanufacturing and examples that may be help to industry. Additionally, the guidance recommends certain information be included in the labeling of reusable medical devices regarding their preventive maintenance and repair, including instructions on how to adequately return a device to its performance and safety specifications established by the OEM. The FDA began more closely examining remanufacturing and servicing and the impact of such activities on the quality, safety and continued effectiveness of devices in 2016, when the agency opened a public docket and held a workshop to get public and industry input. Subsequently, the agency published a report, “FDA Report on the Quality, Safety, and Effectiveness of Servicing of Medical Devices,” which detailed the FDA’s plan to provide clarity on the distinction between remanufacturing and servicing that was consistently requested in public comments. The final guidance is an output of that report.