In late September, the FDA released its final report on the Software Precertification Pilot Program, which it launched in 2017 to explore different regulatory approaches for digital health tools.

By 2022, the agency determined a new regulatory framework would be useful for software as a medical device, but it couldn't do that alone.

"We are not fully capitalizing on these capabilities and approaches for software in the current statutory and regulatory framework for medical devices," the FDA wrote in its report. "Based on these observations from the pilot, FDA has found that rapidly evolving technologies in the modern medical device landscape could benefit from a new regulatory paradigm, which would require a legislative change."

David Rosen, a partner and public policy lawyer at Foley & Lardner, notes there have been big changes in the digital health space in the past five years, including advances in consumer wearables and tools that aim to guide clinician decision-making. He sat down with MobiHealthNews to discuss the Pre-Cert pilot program and how digital health companies should approach the regulatory process.

MobiHealthNews: What were some of your big takeaways from the Pre-Cert pilot?

David Rosen: The whole idea behind the Pre-Cert program was to look at different regulatory approaches to try to assist companies in developing software for use as a medical device. And it was predicated on companies making sure that they have a robust quality organization and organizational excellence, and that they do some real-world monitoring of the software as it's being used. 

In general, I think that's a very appropriate goal and a good goal for the FDA to consider, because this is the evolution of how healthcare is being delivered. The model is evolving, and we have this new paradigm, and I think the FDA has to be open to shifting how they regulate things outside of the normal scope of traditional medical devices that they typically see. 

You saw the report from Sept. 22, and there were a few limitations. There were only a few devices available for consideration. There were nine participants. But the FDA didn't want to have a significant number of products going through the De Novo process, because they didn't know how that process was going to work. So that was kind of a very interesting little situation for the FDA to evaluate. 

Again, the whole idea behind the pilot Pre-Cert program was to help companies and help the FDA better understand the design and development and management of digital health products. So I think that the Pre-Cert program did help with that. But I think the bottom line is that the FDA decided that the current regulatory paradigm isn't going to work for this, and that they need a different FDA regulatory pathway and review process to deal with software as a medical device.

MHN: So what do you think digital health and health tech companies should take from this program and these results?

Rosen: First, they need to watch what the FDA is going to be doing in the future. This culture of quality and organizational excellence though, in terms of verification and validation of software, is really, really important. 

I've worked on a lot of these products, and you see companies have different approaches in how they want to verify and validate the usefulness of the data. And I think that we have to be very circumspect, and the companies have to be very circumspect, and they need to work and educate the FDA on how their program works and why the metrics are appropriately valid to come up with some sort of treatment decision. It needs to be a cooperative approach between the industry and FDA to move this whole situation forward to help bring new products into the marketplace.

MHN: You previously worked at the FDA. What are some of the big challenges that you see when it comes to regulating software?

Rosen: The whole pandemic situation has really made it very difficult, because CDRH [Center for Devices and Radiological Health] has been really inundated with COVID-19, in-vitro diagnostic tools and things like that. It was a lot better when we could do things in person. We could have a meeting, and we could do a demonstration, and we could have more interactive dialogue with the FDA. I think those are the kinds of things that really help both the FDA understand what industry is doing, and then help the industry understand and appreciate FDA expectations as to how to develop these products.

MHN: I also wanted to ask about the FDA's recent guidance on clinical decision support software qualifying as medical devices. What do you think this signals about the FDA's process right now?

Rosen: Anytime that the FDA is issuing guidance we look at what the motivation was for issuing those guidances, how much experience that the agency has had, and the regulatory process at this stage. 

I think they've seen a number of people coming out with clinical decision support software. I think it's important to level-set the expectations associated with that software and to ensure that it's helpful to the industry, to say "Hey, this is what FDA is thinking, this is what the expectations are." It doesn't necessarily mean to set out a rigid approach to what you have to do. But it certainly sets forth what FDA is thinking about.

I think it's a very positive situation when you see the agency moving forward, issuing these types of guidances. They're thinking about these things, and we will have a better regulatory understanding and regulatory scheme in the future for these types of innovations in healthcare, which I think is really important at this stage.