The Covid-19 pandemic has created both opportunities and obstacles for the medtech industry. Where those in the diagnostics space saw a window of opportunity open up, the cancellation of non-emergency procedures left many device developers in the lurch and suffering unexpected hits to their annual profits.
To facilitate the flow of essential products like diagnostics, breathing aids and, eventually, vaccines on to the market, the US Food and Drug Administration (FDA) began to enact Emergency Use Authorization (EUA) legislation. EUA allows the FDA to authorise unapproved medical products, or allow them to be used in an unapproved way, during public health emergencies, providing more timely access to critical medical products.
Hyman, Phelps & McNamara director Jeffrey K. Shapiro has specialised in medical device law for more than 25 years, advising and representing medtech companies as they grapple with FDA legislation. Medical Device Network joined him for a conversation on the future of EUA legislation, the FDA’s ongoing deprioritisation of certain devices and how the agency will work post-Covid.
Chloe Kent: What should medical device companies be expecting from the FDA over the next six to 12 months?
Jeffrey Shapiro: I think somewhere in there will be the Covid-19 wind-down, assuming we don’t get variants or some other curveball. You can already see that they’re jettisoning some parts of their workloads – they have to triage what they spend their time on and you can see them deprioritising categories already. I would imagine that may start to accelerate.
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At some point there will be a termination of EUAs, but the statute specifically says that this has to be done in an orderly way. They can’t just pull the plug and say, ‘Okay everyone, your EUAs are over’, there’s an orderly process that they are supposed to institute in consultation with industry. It’s never been done before, so it’s hard to know what that looks like, and it may not start until the federal government declares the pandemic over.
Based on the history of prior pandemics like H1N1 where emergency has been declared, it could be quite some time – maybe even beyond the next six to 12 months. For H1N1 it was in effect for 14 months, and the scale and the scope of this is many orders of magnitude larger, so it may be a year or two before they officially pull the plug.
CK: You wrote a blog post last month about the ongoing deprioritisation process – how can companies working in Covid-impacted spaces prepare themselves for this?
JS: Well, it’s easier said than done. The problem is that there’s not a public list or database of what’s been deprioritised, so you kind of have to read the signs. Through our work we come across several incidences where things are starting to deprioritise so we can start to see a pattern, so if we’re working with clients we can tell them which way the wind is blowing.
The in-vitro diagnostics folks have a weekly virtual town hall that and they make statements in there, or there may be statements in other templates and guidance they put out that may give some idea of their priorities. For example, we know they’re focused on point-of-care and home-use tests now. A few months ago they deprioritised serology tests, and laboratory PCR isn’t high on the priority list. It’s just a matter of keeping on top of what public statements come out of the FDA, maybe consulting with people who would have exposure to a wider variety of cases than one company has and watching which EUAs do come out and what technologies they use.
CK: Will there be any major changes in the way the FDA works post-Covid, or will things revert to how they were in late 2019?
JS: I’m guessing there will be a reversion to the norm. The EUA process is interesting, because it’s hard on both parties. The cycles are faster when they consider your product a priority, and I don’t think FDA can handle that indefinitely, they’re going to revert to their usual timescales.
As an example, they came out with an unfortunate letter about thermal scanners that were being improperly advertised under Covid guidance. That can be very effective. It can destroy a brand name, and properly so, for someone who’s improperly selling a device, because consumers have access to that information in a way that they wouldn’t have not that long ago. So the FDA as a trusted source of information about devices becomes an enforcement tool, which is something they have been using in this pandemic to a degree we’ve never seen before.
I suspect they’re going to continue to do that, because they don’t have the resources to go after every seller in these demographics. Putting people on a list can be a very effective way to achieve a regulatory goal, and I’m guessing we’re going to see more of that.
CK: What are the major trends you’re seeing among companies you’re working with at the moment?
JS: Segments of the industry dropped everything to turn to Covid and from what I can see that hasn’t really abated yet, so one trend is Covid diagnostics. We still see non-Covid diagnostic development, but it’s almost like that segment was hijacked by the pandemic.
There’s lots of good work going on in surgical robotics. Intuitive Surgical came out in the late 90s and created the first and really the main platform, but that technology is a little bit long in the tooth and there’s a lot of other companies coming up with some really interesting stuff. I saw my first surgical robot back in the 90s, but what is happening now is so much more sophisticated.
Also there’s a lot of interesting work going on in digital therapeutics, behavioural things. The jury’s still out on how far that goes but there’s some really interesting products coming out and some good clinical data. Digital obviously has lots of different uses and I don’t think we’ve even begun to exhaust that.
CK: Do you see artificial intelligence (AI) regulation becoming less nebulous anytime soon?
JS: These technological leaps or innovations can go two different ways. Either they can be folded into the FDA’s normal approach or they can lead to a separate way of handling things, and I’m still not sure which way AI is going.
When it’s incorporated into device functionality and based on a fixed data set, it looks very similar to normal technology but with improved functionality. But there are aspects of AI that are very radically different, particularly the ability of the software to learn and improve with real-world data that it encounters. I don’t think the FDA has any idea how to regulate that, because it’s totally outside the usual paradigm of developing a medical device, validating it, marketing it after FDA review and then the performance characteristics don’t change. Here, by definition, they are supposed to change and the FDA hasn’t figured out how they’re going to handle it yet.
CK: If you had a message for the FDA and medtech industry, what would it be?
JS: Despite progress, we still need better communication. Communication and the lack thereof still causes problems where there need not be.