FDA Issues Final Guidance to Clarify “Remanufacturing” of Devices that Need Maintenance or Repair

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Today, the U.S. Food and Drug Administration 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 seeks to ensure that there is consistency regarding what constitutes remanufacturing activities and to promote a better understanding of applicable federal law and regulations implicated by remanufacturing activities. The final guidance was issued following the agency’s extensive review of postmarket 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.”

Many medical devices are reused; for instance, infant warmers, ventilators, endoscopes and defibrillators, and proper servicing is critical to the device’s continued performance and overall total product lifecycle. Additionally, many devices are complex and use varying technologies to be safe and effective for their intended use. Without access to information and resources to ensure proper servicing, unintentional remanufacturing, which may cause the device to be out of compliance with and in violation of federal law, can occur. Because of this, the FDA is advising in this guidance that devices include instructions necessary for proper device servicing, as well as providing examples of activities that constitute remanufacturing. 

Remanufacturing is the processing, conditioning, renovating, repackaging, restoring or any other act done to a finished device that significantly changes the finished device’s performance, safety specifications or intended use. Servicing is the repair and/or preventive or routine maintenance of one or more parts in a finished device, after distribution, for purposes of returning it to the safety and performance specifications established by the original equipment manufacturer (OEM) and to meet its original intended use. 

The FDA determines whether the specific tasks performed on the device constitute “remanufacturing” activities according to the authorities in the Federal Food, Drug, and Cosmetic Act and its implementing regulations, such as the quality system regulation, but not according to an entity’s self-identified designation as a “remanufacturer” or a “servicer.” Simply put, remanufacturing is when a significant alteration is made to a device’s performance, safety specifications or its intended use, changing the device from what was legally marketed as approved, cleared or authorized by the FDA. 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 helpful 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 labeling recommendations do not encourage the disclosure of trade secrets or confidential commercial information. The FDA believes including this information should be considered an industry best practice going forward.

Third-party servicers are entities, other than the manufacturer or healthcare delivery organizations using the device, that maintain, restore, refurbish, repair or service a finished device after distribution, for purposes of returning 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 stakeholders’ perspectives regarding the need for proper servicing that ensures quality, safe and effective devices remain available throughout their use life. 

The availability of timely, cost-effective, quality maintenance and repair of medical devices is critical, both to the successful functioning of the U.S. healthcare system and the public health. The FDA’s regulations and policies should not be considered an impediment to sharing information, tools and access to third-party servicers, as these policies are intended to help facilitate high-quality servicing by all entities engaged in these activities. 

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. Today’s guidance is an output of that report and the agency’s overall commitment to collaborating with industry to improve patient access and a continuing supply of safe and effective, high-quality medical devices.  

Related Information

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Source: U.S. Food and Drug Administration (FDA.gov)