When things go awry, we often hear the rather dubious claim that goes something like this: "I hate to say I told you so, but..." Truth be told, that's silly. We love being able to say we told you so. We're human! In that spirit, when it comes to the FDA's recent announcement about getting rid of the substantial equivalence standard for 510(k) devices, let me say this: I told you so. To recap, the latest set of FDA proposals regarding the 510(k) program, including a rather oafish doing-away with the substantial equivalence standard, have drawn a lot of ink...