Medical Device Third-Party Servicers: Will FDA Treat You as a Manufacturer?
Last week, in response to requests by stakeholders, FDA extended the deadline for comments to its draft guidance "Remanufacturing of Medical Devices," which provides the agency's current thinking regarding the distinction between "servicing" and "remanufacturing" of reusable medical devices. Comments are due by September 22, 2021.
Why did FDA release the draft guidance?
The draft guidance is part of FDA's efforts over the past several years to distinguish device servicing from device remanufacturing—only the latter of which is subject to active regulatory oversight by FDA. After opening a public docket for comment in 2016, FDA determined that a majority of the comments, complaints and adverse event reports regarding "servicing" were in fact due to inadequate "remanufacturing." FDA's findings were published in a report in 2018. The draft guidance aims to clarify whether those who service medical devices are actually engaged in remanufacturing of the device.
Who should read the draft guidance?
You should read the draft guidance if you are a third-party business or OEM that services, repairs, processes, conditions, renovates, repackages, restores or performs other acts on a finished medical device that already is in the market. The device must be intended to be reused and maintained over its useful life, and includes software and electronic products that meet the definition of a device.
What is the difference between "servicing" and "remanufacturing"?
“Servicing” includes repair and preventive or routine maintenance of a finished device or its parts, after distribution, to return the device to the OEM’s original safety and performance specifications to meet its intended use. Servicing can include replacing worn or broken parts or otherwise restoring the device to “like new” condition. However, lack of necessary information from the OEM could result in third parties unintentionally engaging in remanufacturing.
“Remanufacturing” also is performed after distribution of the device, but significantly changes the device’s performance or safety specifications or its intended use from the original device—which, in turn, can raise new patient safety concerns. Remanufacturing includes, among other things, processing, conditioning, renovating, repackaging and restoring a device. For instance, sharpening an orthopedic drill bit can result in a decrease in diameter that is outside of the OEM's specifications, which can lead to patient injury from an opening that can no longer accommodate a once-compatible fixation rod. Other examples of what might constitute remanufacturing include: (i) swapping out an identically sized and configured part made from a different material that might have a different biocompatibility profile; (ii) repairing a break with an adhesive that might not withstand the manufacturer's reprocessing instructions; (iii) replacing an OEM motor with an off-the-shelf version that has a different power output that could affect speed; or (iv) designing and manufacturing replacement parts that do not meet original OEM tolerances.
Why does the difference between servicing and remanufacturing matter?
Because remanufacturing can raise significant new issues of safety and effectiveness, FDA treats third-party device "remanufacturers" in a similar way to "manufacturers." This means that remanufacturers are subject to regulatory requirements applicable to medical device manufacturers, including FDA registration and listing; marketing submissions (where applicable), compliance with current good manufacturing practices, medical device reporting, etc. Those who merely "service" a reusable device are not actively regulated by FDA, though they are subject to FDA’s regulatory authority.
How is the draft guidance helpful?
The draft guidance provides principles that firms should use when assessing if activities performed constitute “remanufacturing”. These include: (i) assessing if there is a change to intended use; (ii) evaluating the effect of activities, both individually and cumulatively, on performance and safety specifications (e.g., through comparison with the original device or verification and validation testing); and (iii) assessing the addition, removal or change of component/part/material or changes to dimensional and performance specifications. The assessment should be performed using a risk-based approach as explained further in the guidance. An activity that raises new risks or significantly modifies known risks likely is remanufacturing. The draft guidance notes that FDA is of the general belief that changes to sterilization methods, reprocessing instructions and a device's control mechanism, operating principle or energy type are significant changes to performance or safety specifications. It also includes a flow chart and description of the types of considerations and activities firms may want to undergo when making their evaluations.
Regardless of whether you consider yourself a servicer or remanufacturer, FDA recommends that determinations as to whether an activity does or does not constitute remanufacturing should be adequately justified and documented, including references to any supporting verification and validation data. In this regard, the draft guidance includes examples of decision-making and documentation. It also encourages OEMs to include servicing instructions in their reusable device labeling to facilitate routine maintenance and repair.
What about software changes?
The guidance has a separate section related to software for which FDA believes a different approach is warranted. Instead of a risk-based approach, the guidance lists activities that FDA believes likely are not remanufacturing, such as implementing OEM provided upgrades, installing cybersecurity updates authorized by the OEM or assessing for viruses and malware. According to FDA, other changes to software likely are remanufacturing.