FDA has released draft guidance on the remanufacturing of medical devices for consultation, advancing a multi-year effort to clarify its position on the issue which hasn't been clear in the past.
Many reusable devices need servicing but at some point repair can become "remanufacturing." The agency's draft guidance, which is open for comment until Aug. 17, is intended to bring the previously blurry distinction between servicing and remanufacturing into sharper focus.
- Peter Weems, director of policy at the Medical Imaging and Technology Alliance, said MITA is still reviewing the document but sees the draft guidance as a "step in the right direction" laying out strict requirements for third-party device servicers "to make sure that their activities don't cross into remanufacturing" and "if they do, understanding their regulatory responsibilities." FDA also published a discussion paper on the cybersecurity issues specific to the servicing of medical devices.
FDA discussed the lack of clarity on the distinction between servicing and remanufacturing in a 2018 report. One of the main conclusions of the paper was that most reports linking inadequate servicing to clinical adverse events and deaths actually relate to remanufacturing. The next year, a bipartisan pair of senators asked FDA to share details of planned draft guidance on remanufacturing. At that time, FDA planned to publish the draft by September 2020.
Now, after a COVID-19-affected 2020, FDA has belatedly published the draft guidance. The document defines remanufacturing as "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, in contrast, 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 OEM and to meet its original intended use."
The draft guidance fleshes out the distinction with guiding principles, flowcharts and other resources for determining whether an activity is remanufacturing. FDA wants organizations involved in the maintenance of devices to assess whether changes affect the intended use, determine whether their actions alter safety or performance specifications and evaluate the need for a new marketing filing.
MITA's Weems contends that there's a lot of remanufacturing that's being conducted by unregulated third-party device servicers that are "operating underneath the FDA's radar" and falling through the regulatory cracks.
"This guidance will hopefully clarify that line between servicing and remanufacturing," Weems said, driving device servicers to "come into compliance with applicable regulations."
FDA has condensed the principles and considerations for device servicers into a flowchart designed to help determine if an activity is likely to be classed as remanufacturing. The chart poses questions such as if a component that contacts body tissue been changed and, if so, did the modification significantly alter the performance or safety specifications of the device.
"Our only concern so far with this guidance is that FDA will need to have a robust, proactive plan to educate servicers about the content of this guidance and their regulatory responsibilities, and take enforcement action as is needed when unaccountable servicing happens," MITA's Weems added.
The agency released the draft guidance alongside a discussion paper on servicing. Rather than mark out the delineation from remanufacturing, the discussion paper details the challenges created when servicing medical devices now that cybersecurity is an issue for many products.
In the discussion paper, FDA poses three questions. The agency wants to know what cybersecurity challenges and opportunities are associated with servicing, whether it has identified the right four priority areas and how entities that service devices can help strengthen cybersecurity.