MERA – The Association for Sustainable Manufacturing – has submitted public comments on behalf of the broader remanufacturing industry to the U.S. Food & Drug Administration (FDA) regarding the importance of common terminology and the FDA’s use of the term “remanufacturing.”
The comments MERA submitted are in direct follow-up to the FDA workshop, “Medical Device Servicing and Remanufacturing Activities,” which took place Dec. 10-11, 2018, in Washington D.C. The workshop was attended by MERA President and COO John Chalifoux, and Butzel Long Attorney Mitch Zajac.
The FDA uses the term “remanufacturing” to identify a process that “significantly changes the finished device’s performance or safety specifications, or intended use.” While we recognize the regulatory need for the FDA to identify a process that could negatively modify an existing device, calling it “remanufacturing” contradicts the commonly accepted definition published by the U.S. International Trade Commission (USITC). According to the USITC, remanufacturing is “an industrial process that restores end-of-life goods to original working condition or better.”
To encourage the FDA to align with other industry sectors, MERA’s comments in summary state:
“MEMA and MERA urge the FDA to recognize today’s commercial reality and no longer use the term ‘remanufacturing’” when referring to a modification process that ‘significantly changes the finished device’s performance or safety specifications, or intended use.’ By doing so, the FDA will align with other government agencies and industry sectors; curtail confusion among consumers; lower the risk to patient safety; and advance the U.S. economy and international trade.
To read MERA’s submitted comments in full, click here.