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 in the trade press, and for good reason. Many of these proposals are entirely extralegal, a predicament with which the agency is far too familiar, but many of us have blamed this latest rash impulse on the agency's part on the Implant Files series by the International Consortium of Investigative Journalists.

That's speculative, but there may be a grain of truth to it despite that the two "authors" of the FDA statement on the 510(k) program have different tendencies in this regard. Jeff Shuren, director of the Center for Devices and Radiological Health, has a well-documented distaste for the 510(k) program, but FDA commissioner Scott Gottlieb's impulses are presumed to lean toward less regulatory adventurousness. His moderately conservative bona fides were pretty well established during his time at the American Enterprise Institute, and he certainly has been no friend of the agency where the commercial speech question is concerned.

Agreeing not to disagree

On the other hand, these two government employees might comfortably fit both their signatures on this memo about substantial equivalence if it is, indeed, largely a reaction to the ICIF. For Shuren, this is old hat and thus not even remotely a stretch, while for Gottlieb, it would be a way to deflect criticism, however temporary the effect might be.

Assuming for a moment this is more of a head fake on Gottlieb's part, it's one he can afford if one assumes the agency would indeed need the help of Congress to pull it off. The 116th Congress does have a Democratic majority in the House, which would presumably at least not be flatly opposed to the idea. That's not even remotely true of the Senate, however, and we all know by now that this kind of thing would never fly in the Oval Office.

So for Gottlieb, this is dessert with no calories. We should all be so lucky this time of year.

The net effect of all this is that the FDA – assuming it is serious about dumping substantial equivalence for objective performance criteria – has a nearly impossible lift in front of it. The agency has no shot at statutory authorization, and should it proceed with this plan without legislative authorization, you can be sure the matter will show up in the U.S. District Court for the District of Columbia with a ton of amicus curiae arguing (quite correctly, in my view) that the agency is way out of bounds. I'm reasonably certain the Washington Legal Foundation would join in on the lawsuit, and they have had some success in legal scrums with the FDA.

All in all, it's tough to avoid the conclusion that this is a losing proposition for the FDA, but that won't take substantial equivalence off the endangered species list. As the FDA has noted, 510(k) filings have ballooned in size over the past few years, a trend that might continue.

Ultimately, device makers may more frequently find that additional requests for information start to resemble requests for objective performance criteria, and it's certainly not as if reviewers at the Office of Device Evaluation have no history of renegade behavior. We may trust they've all seen the ICIJ coverage, and when one adds the Netflix program, "The Bleeding Edge" to the picture, a new wave of resentment and resistance may quietly emerge at ODE. This predicament certainly bears watching.