FDA issues final guidance clarifying “remanufacturing” of devices requiring maintenance or repair

SILVER SPRING, Md., May 9, 2024 /PRNewswire/ — Today, the U.S. Food and Drug Administration issued final guidance intended to provide the medical device industry with clarity on the definition of “remanufactured” for reusable devices requiring maintenance or repair. The final guidance is intended to provide consistency in what constitutes a remanufacturing activity and to promote a better understanding of applicable federal laws and regulations related to remanufacturing activities. The final guidance was issued after an extensive review of post-marketing information by the agency and consideration of public comments that highlighted the need for transparency given the different regulatory implications between “servicing” and “remanufacturing” a medical device.

“Today’s action is an important step forward in our mission to ensure patients have continued access to high-quality, safe and effective medical devices,” she said. Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health. “This guidance provides important clarity on the definition of reprocessing and helps remove perceived barriers to obtaining repair or maintenance of a device where it does not alter safety, performance or intended use.

Many medical devices are reused; for example, baby warmers, ventilators, endoscopes and defibrillators, and proper servicing is crucial to the continued performance of the device and the overall product lifecycle. Additionally, many devices are complex and use different technologies to be safe and effective for their intended use. Without access to information and resources to properly support it, unintentional regeneration may occur and could cause the device to be out of compliance with or in violation of federal law. For this reason, FDA recommends in this guidance that devices include instructions necessary to properly service the device and also provide examples of activities that constitute remanufacturing.

Remanufacturing is the processing, conditioning, refurbishment, repackaging, restoring or any other activity performed on a finished product that significantly changes its performance, safety specifications or intended use. Servicing is the repair and/or preventive or routine maintenance of one or more parts of a finished device after distribution, to return it to the safety and performance specifications established by the original equipment manufacturer (OEM) and to meet its original intended use.

FDA determines whether certain tasks performed on a device constitute “restorative” activities under the provisions of the Federal Food, Drug, and Cosmetic Act and its implementing regulations, such as the quality system regulations, but not under the entity’s self-monitoring. identified the designation as “regenerator” or “servicer”. Simply put, reprocessing occurs when a significant change is made to a device’s performance, safety specifications, or intended use, changing the device from what it was legally marketed as FDA cleared, cleared, or authorized. The final guidance outlines the guiding principles that FDA recommends applying in the remanufacturing context, a flowchart to help determine whether activities may include remanufacturing, and examples that may be helpful to industry.

Additionally, the guidelines recommend that reusable medical devices include certain preventive maintenance and repair information on the label, including instructions for appropriately restoring the device to its OEM-established performance and safety specifications. The labeling recommendations do not encourage the disclosure of trade secrets or confidential business information. The FDA believes that including this information should be considered future industry best practice.

Third-party servicers are entities other than the manufacturer or health care organizations using the device that maintain, restore, refurbish, repair, or service the finished device after distribution to return it to the safety and performance specifications established by the OEM and to meet its original intended use. The Agency continues to recognize the importance of stakeholder perspectives on the need for appropriate servicing to ensure the availability of high-quality, safe and effective equipment throughout its useful life.

The availability of timely, cost-effective, and high-quality maintenance and repair of medical devices is critical to both the successful operation of the U.S. health care system and public health. FDA regulations and policies should not be considered an obstacle to the availability of information, tools and access to third-party service providers, as these policies are intended to facilitate high-quality service by all entities involved in this activity.

The FDA began to more closely examine remanufacturing and servicing and the impact of such activities on the quality, safety and continued effectiveness of devices in 2016, when the agency opened the public list and held workshops to solicit public and industry feedback. The agency subsequently released a report, “FDA Report on the Quality, Safety, and Efficiency of Medical Device Servicing,” which details FDA’s plan to provide clarity on the distinction between remanufacturing and servicing, which has been consistently requested in public comments. Today’s guidance is the result of this report and the agency’s overall commitment to working with industry to improve patient access and the continued supply of safe, effective, high-quality medical devices.

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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness and security of human and animal drugs, vaccines and other biological products for human use, and medical devices. The agency is also responsible for the safety of the supply of food, cosmetics, dietary supplements, electronic products that emit radiation, and for regulating tobacco products.

SOURCE U.S. Food and Drug Administration