AdvaMed Concerned with Device Remanufacturing Guide
Advanced Medical Technology Association (AdvaMed) says there are inconsistencies and ongoing concerns with FDA’s guidance entitled “Remanufacturing of Medical Devices: Guidance for Industry, Entities That Perform Servicing or Remanufacturing, and Food and Drug Administration Staff.”
In comments submitted about the final guidance, AdvaMed contends that when an earlier draft guidance was issued it pointed out that it was “misleading to focus on whether the change made to the device in question was ‘significant,’ as that standard applies only to 510(k)-cleared devices, not to PMA devices. Moreover, that standard applies to changes made by the original equipment manufacturers or OEMs (i.e., the sponsor), not by a third party. Unfortunately, the Final Guidance fails to correct this source of confusion, and as a result creates a false impression that third parties may make certain changes to a device without needing FDA clearance or approval and without meeting other applicable requirements. FDA should re-issue the guidance to clarify that even if a third party effectuates changes to a device that are not significant, particularly in the context of high-risk devices, those changes subject the third party to registration and listing and other device requirements.”
The group further notes that a third party, whether it characterizes itself as a servicer or a remanufacturer or neither, cannot make a “non-significant” change to a PMA-approved device without independently meeting device requirements for a high-risk device. “Whether or not FDA has opted to exercise some degree of enforcement discretion for device servicing, as opposed to remanufacturing,” AdvaMed writes, “this final guidance unfortunately creates a fals impression that a third party may make changes to a device as long as the third party concludes the change is not ‘significant.’ This is inaccurate as a matter of law, and will exacerbate risks to public health, particularly in the context of high-risk, PMA-approved devices.”
Additionally, AdvaMed urges FDA not to allow remanufacturers to restore or revert software to original performance and safety specifications or to a previous configuration because these cannot be confirmed by a third party without permissions and training from OEMs. “Doing so may ‘undo’ or reverse patches and other changes made to the device’s software to address new cybersecurity threats or activity or to make upgrades to the device and may lead to unsafe and/or ineffective devices,” the group says.