The FDA’s final guidance aims to clarify the definition of “remanufacturing” for reusable medical devices, distinguishing it from routine servicing to ensure compliance with federal regulations.
RT’s Three Key Takeaways:
- The FDA’s final guidance clarifies the distinction between “remanufacturing” and “servicing” for reusable medical devices, ensuring regulatory compliance.
- The guidance includes principles, a flowchart, and examples to help the medical device industry understand and apply the definitions accurately.
- Proper servicing is emphasized to avoid unintentional remanufacturing, which could lead to violations of federal laws and impact device safety and performance.
The US Food and Drug Administration (FDA) 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 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,” says Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, in an FDA bulletin. “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.”
Importance of Proper Servicing
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, according to the FDA. 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,” reads the bulletin. “Because of this, the FDA is advising that devices include instructions necessary for proper device servicing, as well as providing examples of activities that constitute remanufacturing.”
Defining Remanufacturing vs. Servicing
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.
FDA’s Determination Process
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,” reads the bulletin.
Guiding Principles and Labeling Recommendations
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.
Background and Industry Input
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.
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