9 companies will play a huge role in shaping the FDA’s novel approach to digital health

The FDA has a basic structure in mind for its precertification program, but pilot participants will have an outsized influence.

As the Food and Drug Administration begins a substantial overhaul of its approach to regulating health technology, a handful of software companies are poised to have a significant impact on the agency’s methodology moving forward.

Last week, the FDA announced the launch of a software precertification program, drawing praise from some of the agency’s harshest critics. As part of a newly released Digital Health Innovation Plan, the agency will select nine companies to participate in a pilot program that launches September 1.

RELATED: FDA unveils precertification pilot program for digital health technology, maps out upcoming guidance

That year-long phased pilot will serve as the foundation of the precertification program, which represents a noteworthy shift in the way the agency traditionally operates. Rather than regulating products, the FDA will devote its oversight energy to the companies developing those products.

The FDA has a basic framework in mind for the precertification process, but as Bakul Patel, the associate director of digital health at the FDA’s Center for Devices and Radiological Health (CDRH), explained in a webinar on Tuesday, the final structure of the program is still fluid.

“We want to collaborate and be a partner in this learning we will have going forward to actually build a program that will be best-suited for this fast and evolving technology space that actually holds promise for bettering healthcare for the U.S.,” he said.

RELATED: FDA’s Bakul Patel envisions a new regulatory approach to digital health

Patel acknowledged that nine companies represent a small pool, and he repeatedly emphasized the FDA’s desire to make this new iteration of software regulation a collaborative process. He urged developers that aren't included in the pilot to reach out to the agency with suggestions and said the agency is planning a public workshop in January.

But the chance to be a part of that initial pilot program is “a brass ring worth competing for,” Bradley Merrill Thompson, a medical device attorney at Epstein Becker Green, said in an email to FierceHealthcare. 

“Basically, FDA is saying, ‘We're going to have a program, we don't know what it will include, but come be part of it and help design your own regulatory system,’” he said. “That's pretty enticing for any company that plans to be in this area long term.”

What’s more, it appears the FDA is looking for a broad range of participants that vary in both size and experience. Patel even said the FDA would “not shy away” from companies with good software development practices outside of the medical device sector, as long as they have a track record of quality and organizational excellence.

“We are looking at people who know exactly how to develop software and maintain it,” Patel said.

The FDA’s willingness to work alongside the digital health industry is nothing new, Bethany Hills, chair of Mintz Levin's FDA practice, told FierceHealthcare. But moving forward, the FDA’s biggest challenge may be self-inflicted. Shifting its purview from product to enterprise will require a fairly monumental shift in the way the agency approaches oversight.    

“That is certainly going to be an interesting change and may be hard for FDA to implement structurally,” she said.