“We all share the goal of helping patients and their doctors have access to better devices to improve healthcare,” said Sonja Fulmer, PhD, deputy director for the Digital Health Center of Excellence (DHCoE) in the FDA Center for Devices and Radiologic Health (CDRH). How DHCoE is working to support digital health innovators in this goal was the topic of a recent Lunch & Learn presentation Fulmer gave to a full house of innovators and entrepreneurs at Fogarty Innovation.
A clear and predictable path
One of the most significant ways DHCoE is working to achieve the goal of delivering high quality products to patients is providing a “clear and predictable path to market” for digital health innovators. To accomplish this, DHCoE is working to help companies understand and navigate that path. “We’re working to reduce the friction,” Fulmer described. “We need to make it a little bit easier for companies to find and understand the guidances that apply to their products.”
The DHCoE is also focused on supporting and enhancing innovator communication with the review teams. “We recognize the value of being able to have a short conversation with your review team to clarify what they’re looking for or get other quick feedback,” said Fulmer. “We’re trying to facilitate that in a way that meets innovators where they are in the development process. Not everything requires waiting 70 days for a pre-sub answer.”
The goal is to not only make interactions with the FDA team more flexible and interactive, but also to democratize the review process so that small startup companies with little previous experience and without paid regulatory consultants can navigate the pathway as effectively as companies with bigger budgets and more expertise. At the same time, this flexible approach will enable DHCoE to evolve and meet the needs of the rapidly changing digital health space.
To facilitate these efforts and make sure everyone is on the same page, DHCoE has created a digital health and artificial intelligence glossary that is available online. “Everyone has slightly different terms and definitions,” said Fulmer. “This is an FDA-wide glossary, meaning that we’ve worked with our colleagues across the agency to compile it so that we can all come to the conversation using the same language.” The hope is that the glossary will also be used by other stakeholders like payers to increase shared understanding.
Defining digital health technology
The FDA defines digital health broadly as the convergence of software connectivity and computing platforms for healthcare, which encompasses everything from healthy living products through those that diagnose, monitor, or provide treatment. A digital health technology includes software that could itself be a medical device. “It’s not your traditional physical device, but it does meet the definition of a device regulated by FDA. It can also be software used in a medical device,” Fulmer clarified.
Accordingly, the first decision health technology innovators need to make is whether their software product meets that definition. In 2016, the 21st Century Cures Act changed the definition of a device for software and was followed by the issuances of a “slew of guidance documents.” To enable innovators to find the policies that apply to their products, DHCoE has condensed them into a tool, the Digital Health Policy Navigator, that goes through a number of yes or no questions to help innovators determine whether a particular software function meets the device description.
If the health technology meets the definition of a device, the next question is whether or not it is the focus of FDA’s oversight. The tool helps with this as well, either guiding the innovator to appropriate documents, or indicating that the software is considered low risk and likely to fall under enforcement discretion. “Not every product that is considered a digital health product or device is subject to FDA’s device oversight,” Fulmer said.
So you have a regulated digital health device
Once a health technology innovator has determined that they have a digital health device that is subject to FDA regulation, the next question is: what guidance documents are applicable to that device? DHCoE is working on another tool that will be a continuation of the Digital Health Policy Navigator, to walk innovators through a series of questions to identify the most helpful documents for device software. “We want to make the submission process easier by clarifying exactly what we’re looking for, so you’re not getting a deficiency because you’re missing pieces,” said Fulmer. “You should know in advance what is required and be able to come to us with that information in hand.”
Early Orientation
DHCoE is also working to improve its interactions with digital health innovators through a pilot program called Early Orientation. This is designed to give innovators a chance to start the conversation with their review team early. “The idea is to walk the reviewer through the submission, and give a demonstration of how the product works,” said Fulmer. “It can be hard to really understand the flow of a product based on screenshots. A demonstration can help us better understand what your product is and what it does.” The meeting, which is supposed to take place within the first two weeks of submitting an application, is meant to be informal. “It’s a conversation that gets everyone on the same page as to what the submission is about,” she said.
Engaging with the Agency
In response to the recent changes and developments in AI, the FDA has established a digital health advisory committee to help the agency better regulate AI products going forward. The first meeting will be in November and will focus on generative AI, including the lifecycle considerations for these products. “I’m hopeful that a lot of folks will come to that meeting and share their experiences and help us find the right mitigations for the risks that these products present so that we can support innovation in this space,” Fulmer said. “It’s one example of how we need to work with industry – with experts in this field – to help us get this right.”
She also offered an additional resource for digital health innovators – the digital health inbox. “It’s just digitalhealth@fda.hhs.gov and it’s a way to get rapid feedback. If you have a question about regulatory status, if something doesn’t make sense in a guidance document, or if you’re not sure what to do next, we have a team of DHCoE experts who respond to these questions within two weeks,” she said. “Sometimes the answer is that you need to go do a pre-sub, but at least we can help figure out that next step. It also establishes a relationship with us so we can help you move forward.”