Remanufacturing of Medical Devices; Draft Guidance for Industry and Food and Drug Administration Staff
Strengthening Cybersecurity Practices Associated with Servicing of Medical Devices: Challenges and Opportunities; Discussion paper
The FDA seeks input on the discussion paper "Strengthening Cybersecurity Practices Associated with Servicing of Medical Devices: Challenges and Opportunities." Submit comments before September 22, 2021.
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A remanufacturer is defined as any person who processes, conditions, renovates, repackages, restores, or does any other act to a finished device that significantly changes the finished device's performance or safety specifications, or intended use. [21 CFR 820.3(w)]. The FDA considers remanufacturing to be a distinct activity from servicing that raises different concerns, and is thus regulated differently.
The availability of timely, cost-effective, quality maintenance and repair of medical devices is critical both to the successful functioning of the United States (U.S.) healthcare system and to the continued quality, safety, and effectiveness of marketed medical devices in the U.S. This is very important for those devices used on numerous patients over long periods of time. Poor quality servicing may lead to poor device performance, device malfunction, and adverse events. Cybersecurity is also an important consideration in the servicing of medical devices.
The distinction between "remanufacturing" and "servicing" is important to understand. 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 or 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. Regardless of an entity's self-identified designation as a "servicer" or "remanufacturer," the FDA focuses on the specific activities an entity performs on a particular device. The determination of whether the activities an entity performs are remanufacturing affects the applicability and enforcement of regulatory requirements under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and its implementing regulations. The FDA enforces requirements under the FD&C Act and its implementing regulations on entities engaged in remanufacturing, including but not limited to registration and listing, adverse event reporting, the Quality System (QS) regulation, and marketing submissions.
- Servicing Discussion Paper: Strengthening Cybersecurity Practices Associated with Servicing of Medical Devices: Challenges and Opportunities (June 2021)
- White Paper: Evaluating Whether Activities are Servicing or Remanufacturing (December 2018)
- Servicing Report: FDA Report on the Quality, Safety, and Effectiveness of Servicing of Medical Devices (May 2018)
- Public Workshop - Medical Device Servicing and Remanufacturing Activities, December 10-11, 2018
- This two-day workshop was intended to publicly discuss the distinction between medical device servicing and remanufacturing activities to better inform the development of a future draft guidance, as well as discuss opportunities for collaboration among medical device servicing and remanufacturing stakeholders.
- Public Docket Comments (No. FDA-2018-N-3741)
- Public Workshop - Refurbishing, Reconditioning, Rebuilding, Remarketing, Remanufacturing, and Servicing of Medical Devices Performed by Third-Party Entities and Original Equipment Manufacturers, October 27-28, 2016
- This two-day workshop was intended to convene interested stakeholders to discuss regulatory aspects of third party processes including refurbishing, reconditioning, rebuilding, remarketing, remanufacturing and servicing. To promote an understanding of challenges and best practices to mitigate risks associated with these activities, the workshop included FDA remarks, stakeholder perspectives, and four panel discussions based on public docket comments.
- Public Docket Comments (No. FDA-2016-N-0436-001)