- FDA announced a pilot program that might result in a "pre-certification" for digital health startups.
- That would provide some much-needed clarity for digital health startups, and a potential fast-track to get a green-light from regulators.
On Thursday, FDA commissioner Scott Gottlieb announced a pilot program to look into a "pre-certification" for medical software start-ups.
And even the FDA's harshest critics are excited about it.
"I guess I've grown cynical in my old age, as I've watched administrations come and go," said Bradley Merrill Thompson, an FDA expert and lawyer with the firm Epstein, Becker & Green, in an email to CNBC. "[But] I think the idea of a pilot program is brilliant."
The agency is hoping to fast-track the approval process for medical software start-ups and products that are less risky for patients than a traditional medical devices. The idea is that these companies could submit less information than is currently required -- or none at all.
The FDA will let up to 9 companies sign up for this pilot. After that, fast-track approval could become the norm.
Thompson praised Gottlieb's agenda a month ago when the FDA announced plans for a digital health innovation plan. At that time, he was hoping that the agency would move ahead with a pilot program or sorts, so it could gather feedback from the industry.
"This stuff is really hard to figure out in the abstract," he said. "It's really only by working with companies and tinkering and experimenting that we can truly identify the best model."
The agency also shared an action plan with timelines on how it intends to regulate digital health companies.
"Historically, healthcare has been slow to implement disruptive technology tools that have transformed other areas of commerce and daily life," acknowledged Gottlieb, a doctor and former venture capitalist, in a blog post.
"One factor that's been cited, among many, is the regulation that accompanies medical products," he wrote. "But momentum toward a digital future in healthcare is advancing."