As device makers know all too well, the acronym NSE means not substantially equivalent, which is not the desired outcome in connection with a 510(k) filing. However, there’s another predicament that doesn’t look substantially equivalent, either. That’s the function of the FDA pre-certification concept and the 510(k) program as a whole. The reason this lack of equivalence is topical at this moment in regulatory history is that even a casual reading of recent tea leaves suggests that the agency is yet again on the march in an effort to excise the nettlesome 510(k) program.
The pre-cert program has its nominal origins in the FDA’s digital action plan, ostensibly an effort to loose a thousand points of software light upon the American populace. Critics have charged that the pre-cert concept is largely or entirely extralegal, however, and even members of the FDA have implicitly acknowledged as much. Bakul Patel, the FDA point man on matters digital, said on a stakeholder call in June that the agency’s approach consists of standing up a pre-cert pilot program and then only belatedly asking how it might fit into the agency’s current authorities.
The pre-cert concept is starting to show up in other areas as well, however. It is widely known that the concept has been floated in connection with lab-developed tests, but the FDA medical device safety action plan invokes the notion of objective performance criteria (OPC) as a substitute for demonstrations of substantial equivalence. Brad Thompson of Epstein Becker Green – who by now is the chief FDA gadfly in all of the regulatory bar – pointed out that the OPC framework’s concomitant use of the Case for Quality program, as a shell for the culture-of-quality concept embodied in the digital pre-cert program, is just as statutorily out of bounds as the digital pre-cert framework.
Forward to the past; IOM’s $2 million baby
Lest anyone see all this as an example of conspiracy theory-driven paranoia, let us recall the 2011 report on the 510(k) program by the Institute of Medicine. That report, which cost the taxpayer the absurd sum of $2 million, said nearly nothing of value other than that the notion of a predicate device was probably essential to the formation of a successor to the 510(k) program. The FDA commissioned that report in a spirit of clear hostility toward the 510(k) program, yet, here we are seven years later with a proposal to render the program obsolete with the use of objective performance criteria, all without the need to plead the case before Congress.
To back up for a moment, let's remember there are three general categories of items regulated by the FDA’s Center for Devices and Radiological Health. They are therapeutic medical devices, legacy diagnostic device types (including IVDs and diagnostic radiology) and digital “devices,” such as health apps, many of which are diagnostics. This doesn't include combo products, of course, but those will never be part of a pre-cert program for obvious reasons. So let’s do a 510(k) countdown.
Can moderate-risk software as a medical device avoid 510(k) filings via the pre-cert program? Check. In vitro diagnostics as a subject of pre-cert that avoids the substantial equivalence standard? Check. Now, we have traditional class II hardware devices as the subjects of a culture-of-excellence paradigm that would also give substantial equivalence the heave-ho.
Device makers can disagree as to whether a pre-cert paradigm concept makes sense, but it’s clear that Congress has pushed the FDA to the brink on the premarket front. That front in the twilight struggle between industry and agency is lost to the FDA, at least for now, but the FDA still has the post-market side to work, and the agency is working it with gusto. After all, these pre-cert programs come with the promise of swifter FDA action in the event the much-ballyhooed NEST super-registry project comes to fruition and sounds the tocsin.
Some have argued that what Congress giveth, the FDA taketh away by whatever means it can. When it comes to patient safety, that’s entirely understandable, but one wonders whether the underlying quid pro quo is thoroughly understood as such, and it’s not as if anyone at the FDA is willing to again publicly advance the argument that the 510(k) program is a regulatory dinosaur. One suspects that view is still widely held at the agency, but it would perhaps be impolitic to give voice to it.
How all this might evolve is yet to be seen, but industry might want to recall the time of Ralph Tyler, who took the job of FDA chief counsel in 2009. Tyler famously advised an audience at the Food and Drug Law Institute’s annual meeting that he had counseled the commissioner that the FDA should not limit its enforcement levers to those explicitly spelled out by the statute, but that the FDA should consider making use of any levers not explicitly forbidden by the statute. It was a stunning announcement, one that signaled the emergence of a bureaucracy seemingly uninhibited by the notion that the least burdensome standard is the natural offspring of the concept that government must demonstrate a compelling state’s interest before intervening in the affairs of the private sector.
It appears that same disregard for administrative modesty still animates those at the device center, who seem bent on introducing regulatory mechanisms never envisioned by Congress, let alone expressly woven into the statute. Although it is not yet clear whether device makers are fully aware of what lay before them, what is coming into plain view is that while the shells look different than they did last time, it’s the same little red 510(k) ball underneath, isn’t it?
Let the shell games begin once again.