FDA unveils digital health pilot program to speed up certification process
- The FDA announced a new voluntary pilot program for digital health companies to focus on market innovation.
- The agency will include nine software companies, and companies can begin submitting statements of interest on Aug. 1.
- FDA's Center for Devices and Radiological Health also published its Digital Health Innovation Action Plan, which provides detail and timelines related to digital health and the 21st Century Cures Act.
FDA Commissioner Dr. Scott Gottlieb said the pilot program is in part reaction to the acknowledgement from the agency that digital health lives in a world where fast innovation is prized, while traditional healthcare is slow to adopt new technologies.
"One factor that’s been cited, among many, is the regulation that accompanies medical products. But momentum toward a digital future in healthcare is advancing," Gottlieb wrote. "Not all of these tools are subject to FDA regulation. For the devices we are asked to evaluate, we know that our policies must continue to empower consumers and facilitate innovation."
The agency is looking to potentially reduce certification checkpoints for software companies for low-risk devices and, as Gottlieb wrote, fosters, instead of hinders, product innovation. "We need a regulatory framework that accommodates the distinctive nature of digital health technology, its clinical promise, the unique user interface and industry’s compressed commercial cycle of new product introductions," he wrote.
The pilot will focus on companies instead of products, according to the blog post.
The FDA during President Barack Obama's administration had already mentioned it would not regulate low-risk wellness devices. Still, digital health companies and providers have both been going through growing pains as companies try to enter the market while providers look for evidence-based results.
The pilot program is likely welcomed by the digital health industry as it shows an offering of good faith to explore the new terrain. The program builds upon the digital health plan released by the agency last month and prior to the hiring spree the agency plans to conduct strictly for digital health in the fall.
"The challenge FDA faced in the past is determining how to best regulate these non-traditional medical tools with the traditional approach to medical product review," Gottlieb wrote. "We envision and seek to develop through the Pre-Cert for Software Pilot a new and pragmatic approach to digital health technology."
The action plan document outlined several digital health action timelines. Highlights include the goal to issue draft guidance on 21st Century Cures implementation by the end of 2017 and on clinical decision support software during the first quarter of 2018.
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- Healthcare Dive FDA chief Gottlieb maps out new digital health plan
- Healthcare Dive 21st Century Cures Act: 4 health industry impacts summarized
- Healthcare Dive What's needed to scale up digital health in the clinical provider space
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