“This voluntary pilot program will enable us to develop a tailored approach toward this technology by looking first at the software developer or digital health technology developer, rather than primarily at the product, as we currently do for traditional medical products. This pilot will help us establish the most appropriate criteria for standing up a firm-based pre-certification program for these new digital health tools.” – FDA
The agency is hosting a webinar on August 1to further explain the Innovation Action Plan and the Software Pilot Program.
FDA has announced its commitment to technologies in digital health in a more concrete way: It established a new initiative, the Digital Health Innovation Plan. Announced by FDA Commissioner Scott Gottlieb, M.D. on the agency’s blog, FDA Voice, the plan will also focus on post-market regulation of digital medical devices.
“For…digital technologies to take hold and reach their fullest potential, it is critical that FDA be forward-leaning in making sure that we have implemented the right policies and regulatory tools, and communicated them clearly, to encourage safe and effective innovation. In this rapidly changing environment, ambiguity regarding how FDA will approach a new technology can lead innovators to invest their time and resources in other ventures.” – Scott Gottlieb, M.D., FDA
The agency will also be working to clarify which digital health technologies fall outside the scope of FDA regulation (i.e., certain clinical administrative support software or mobile apps that are intended for encouraging a healthy lifestyle only).
The pilot program for regulating digital health technology is currently being developed, and the agency is looking at how it can create a third-party certification program under which lower risk digital health technologies could be marketed without FDA premarket review. It is also exploring how this program would work with higher risk products marketed with a more streamlined agency premarket review.
Gottlieb also pointed leveraging real-world data gathered post market, and the information that could be gathered using organizations such as the National Evaluation System for health Technology and the Medical Device Innovation Consortium.