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

The Food and Drug Administration (FDA) followed through on its promise to overhaul the agency’s approach to digital health, rolling out a new precertification pilot program designed to keep pace with health IT innovation.

The FDA’s Software Pre-Cert Pilot Program, part of a broader Digital Health Innovation Action Plan released by the agency on Thursday, would soften the regulatory requirements for digital health companies with a track record of developing and testing quality products.

Broadly, the agency’s plan sketches out a rough timeline for the FDA to provide additional guidance on various types of medical software detailed in the 21st Century Cures Act, including clinical decision support software, mobile medical applications, data systems, medical image storage devices and low-risk wellness products, along with additional clarifications regarding when software modification requires a new 510(k) clearance.

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The official rollout of the FDA’s precertification program—something FDA officials hinted at earlier this year—is a welcomed reform for digital health developers. During the month of August, the FDA will evaluate applications to fill the pilot program’s nine slots, which will serve as a testing ground to develop precertifcaition requirements that “fosters, not impedes, innovation,” FDA Commissioner Scott Gottlieb wrote in a blog post.

Gottlieb emphasized the need to capture an array of developers from “small startups to large companies that develop both high- and low-risk software products.” Ultimately, the program would allow the FDA to regulate developers rather than the software itself, allowing some precertified developers to immediately launch a product and begin post-market data collection.

“There is nothing like this within the framework of FDA regulation,” Bethany Hills, chair of Mintz Levin's FDA practice, said in an email to FierceHealthcare. She noted the companies would still have to do the initial work of determining whether a product is regulated, but precertification would be particularly valuable for companies with multiple products.

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Brad Thompson
Bradley Merril Thompson

Bradley Merrill Thompson, medical device attorney with Epstein Becker Green and the general counsel for the Clinical Decision Support Coalition, was particularly impressed with the FDA’s turnaround time, considering Gottlieb raised the prospect of a precheck program in June. Thompson said he optimistically hoped the agency would roll out a reformed approach sometime next year.

“Now, here we are, a month later, and they’re already moving ahead with the pilot program,” Merrill said in an email to FierceHealthcare. “Apparently, even in my positive comments, I was selling them short.

“It’s rather unbelievable how fast FDA is moving in a positive direction,” he added.

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Overall, Bradley said the FDA’s Action Plan is “extremely well-conceived” in that it intends to reconcile existing digital health guidance with 21st Century Cures legislation. His only “pang of disappointment” was the fact that guidance on clinical decision support software won’t be published until the first quarter of 2018.

“In my mind, this particular guidance is extraordinarily urgent and in fact overdue,” he said.