Medical devices have only been regulated in the US since 1976. That's long enough that bell bottoms have passed in and out of fashion twice. But in federal government years, 30 years isn't a lot of time. Three decades in, we're still learning a few things about what works and what doesn't.
Large-scale learning at FDA is sometimes a planned and gradual process. And other times, it's more like what we're seeing now: the sudden re-thinking of many years of conventional wisdom.
Specific details about the investigation are still sparse. We don't know what type of device sparked the investigation or which specific approvals the committee might investigate. It almost doesn't matter, however. It's difficult to imagine that the investigation they're about to conduct will truly be limited in scope.
Here's why: Prior to the 1976 Ammendment, the device world may as well have been the Wild West. The major barrier to entry in the market was a gut check. If you felt your device was good enough to sell, then that was pretty much good enough.
Just like the Wild West, there were good guys and bad guys. Many manufacturers took their responsibility seriously, but others simply took advantage of the situation. There were few laws and definitely no sheriff in town.
The first job of the 1976 Ammendment and the project that's been undertaken since then has been has been to bring law and order to town. But just like the first sheriff in the Wild West, FDA couldn't simply sweep into town and change everything. They needed to set priorities. They needed to live in town long enough to see what people were doing and assess what the biggest problems truly were. And just like an old-time sheriff, they needed to occasionally look the other way on smaller stuff so they could focus on the bigger priorities.
Eventually the frontier outgrew frontier justice and residents came to resent the tradeoffs that allowed civilization to gain a foothold in the West. It would seem that we are about to experience an upheaval like that with FDA. They have succeeded in raising our expectations of medical devices. Now we're no longer comfortable with some of the tradeoffs we made to get to this point.
One of the most obvious tradeoffs we've made involves the notion of substantial equivalence. An innovative device needs to gather a lot of data to show safety and efficacy before it is allowed on the market. It need to undergo a lot of difficult and expensive study and development work. A me-too product, on the other hand, is allowed to reap the benefit of much of that original work if it can show that it is substantially the same as the innovative product.
So if you invent a whole new type of medical device, you face years of careful development and testing to face an appropriately high level of regulatory scrutiny. But if you come along later and release your own version that changes a few things around, you might get away with submitting little more than a few pages of performance data.
Rewarding copy-cats isn't necessarily the incentive system you want to create. It gets worse, however, when you consider the subjectivity involved in determining whether something is substantially equivalent or not.
The net result is that there are, in effect, two classes of regulation. Some products undergo rigorous testing and others simply don't. It's not always clear why particular products qualify for one or the other category. The stakes are high and the opportunity for undue political influence is obvious.
Insiders have long regarded substantial equivalence as being problematic at best. FDA is the only regulatory body that holds this idea and it has presented a major barrier to harmonizing device regulations with the EU and other leading economies. Though it's nice to occasionally be asked to do less work, the bigger picture is that we're all worse-off when standards are lower or are, to some degree, arbitrary.
I would be surprised if substantial equivalence doesn't turn out to be a key element of the allegations currently being investigated. If it is, this could be a very wide-ranging and far-reaching process we're about to undertake. The committee has signaled that they will be examining specific applications. It's difficult to know where that ends.
FDA has succeeded in raising consumer standards for medical devices. With a rise in standards comes a rise in expectations. The Wild West has indoor plumbing now and we're no longer willing to turn a blind eye to what goes on at the saloon.
Get ready for a different kind of law and order. I'd be surprised if FDA retains (or even wants) much of the discretionary power they curently enjoy. When the dust settles from this current situation, it's reasonable to assume that rules will be enforced more consistently and more strictly. This won't happen overnight, but it's coming.
Tags: CDRH, CDRH Investigation, FDA, Policy
