The problem with
substantial equivalency is that manufacturers have a very low bar set for them — it is still legal for them to prove
substantial equivalency to devices that are no longer being used or to pick and choose parts from different devices.
In DePuy's case (and many others) this allowed them to use mechanical simulators instead of actual humans to prove their «
substantial equivalency.»
... For better or for worse, the rules we have on the books have the language of
substantial equivalency.»
When private schools can deprioritize the core subjects and not meet
substantial equivalency, students lack the tools to reach their full potential.