FDA Issues “Warning Sign” with Release of FDA Remanufacturing Guidance

The ongoing debate regarding the right to repair has heightened tensions between third-party service providers and original equipment manufacturers (OEMs). Third-party repairers are seeking access to OEMs’ closely guarded proprietary information, yet this request is fraught with complexities.

Earlier this month, the Food and Drug Administration (FDA) issued its Final Guidance on Medical Device Remanufacturing, providing clarity on regulatory requirements for manufacturers and third-party servicers who are making repairs. But if you take a deeper look at what the FDA intends to achieve with this guidance, the FDA is actually putting out a word of caution.

Recently, former Associate FDA Commissioner Peter J. Pitts authored a column in RealClear Health, titled, “FDA Issues Cautionary Guidance on Right-to-Repair.”

In his piece he points out how the FDA acknowledges the potential risks of third-party servicers handling complex medical equipment that is critical for saving lives. In fact, if you read between the lines, the FDA is directly confronting the issue that right to repair poses and recognition of its magnitude concerning the sustained quality, safety and efficacy of medical devices.

If you take anything away from this guidance, it should be that the FDA is recognizing the risks associated with improper servicing of medical equipment and encouraging the need for proper oversight and regulation, especially when patient safety and wellbeing are on the line. It is also offering sound advice to protect our healthcare system against any avoidable consequences.

We’re happy to see that the FDA is willing to directly address the issue, taking into account the severity of implications when it comes to ensuring that medical devices remain in precise, working order. Caution is never something we can ignore when it comes to medical devices.