Meet or Exceed
The Corner Office
Wayne Moore
4/3/2025
Just finished reading a “Roundtable” discussion on the general topic of ISO and OEM service options. In my opinion, it really read more like “Why ISOs are Better than OEMs.” Further, to the detriment of the legitimacy of this discussion, it must be noted that there were no representatives from OEMs on this August panel. That obvious hole notwithstanding, the roundtable marched forward into this deep and complicated topic. A long time ago, while obtaining my MBA, I had a marketing class focused on the role of hyperbole in advertising. A quick example of this was the tagline idea for Adobe, “The most magical software on earth,” or from Duracell, “The battery that outlasts time itself.” Both are funny and attention-getting, but clearly, both are exaggerations and understood as such to the consumer. I wish this were the case in the Roundtable discussion where hyperbole often clothed itself as truth.
On May 10th, 2024, the FDA released its long-awaited guidance document covering the differences between remanufacturing and servicing. It could not have been clearer on what activities are servicing/repair and what activities are remanufacturing. To wit: (1) Repair is an activity that returns the device to OEM specification, and (2) if it doesn’t, then the activity is defined by the FDA as remanufacturing. Yet time and again the roundtable said their service/ repair offerings, “…meet or exceed OEM specifications” or some derivative thereof. If the repairs you perform and the parts you use “exceed” OEM specifications, you are, by definition, performing remanufacturing, and you should register as such with the FDA. Words matter. I would suggest to all servicers to purge the phrase “exceed OEM specifications” from their lexicon before the FDA comes knocking on your door.
Until Next Month,
Wayne