FDA opens applications for digital health pre-certification pilot program

By Jonah Comstock

The FDA is moving forward surprisingly quickly with its plan to create a pre-certification program for digital health app developers, originally announced in a blog post by new FDA Commissioner Dr. Scott Gottlieb last month. Now the agency has opened up applications for a nine-company pilot program to develop the program.

The basic goal of the Pre-Cert program, which sets it apart from previous FDA regulatory ventures, is that it will focus not on particular products but on firms and developers. If the FDA is satisfied that the firm is responsible and safe in its development, than it won't need to regulate each product from that firm.

"The goal of our new approach is for FDA to, after reviewing systems for software design, validation and maintenance, determine whether the company meets the necessary quality standards and pre-certify the company," Gottlieb wrote in a new blog post today. "Pre-certified companies could submit less information to us than is currently required before marketing a new digital health tool. In some cases, pre-certified companies could not submit a premarket submission at all. In those cases, the pre-certified company could launch a new product and immediately begin post-market data collection. Pre-certified digital health companies could take advantage of this approach for certain lower-risk devices by demonstrating that the underlying software and internal processes are sufficiently reliable. The post-market data could help FDA assure that the new product remains safe and effective as well as supports new uses."

Applications for the pilot, in the form of statements of interest from companies, will begin August 1. The FDA will also host a webinar on that day to answer questions and give more information about the program. The FDA is looking for a diverse group of applicants.

"FDA designed the new digital health pilot program to include up to nine software firms of various sizes," Gottlieb wrote. "Initial participants in this new pilot will range from small startups to large companies that develop both high- and low-risk software products that are devices. We want to include medical product manufacturers as well as non-traditional software developers. Given the amount of attention we’re getting, and the ongoing innovation in this space, I’m confident we’ll have strong participation in the new pilot."

Bradley Merrill Thompson, an attorney with Epstein Becker Green who advises digital health companies on FDA interactions, said he thinks the program is an impressive step forward.

"I think the idea of a pilot program is brilliant, and not just because we were one of the groups to propose it," he wrote in an email. "This stuff is really hard to figure out in the abstract, and it’s really only by working with companies and tinkering and experimenting that we can truly identify the best model."

Thompson also said he agrees with Gottlieb that the FDA isn't likely to be hurting for applications, despite a lack of clear advantages for companies that choose to participate.

"What is not very clear, and companies will need to take it on faith, is exactly what benefit they will get out of participating in the pilot," he wrote. "The FDA is not very committal about exactly what requirements will be applied to the digital health products these companies produce. So companies will need to approach this from the standpoint of, by participating with FDA, we will learn much about the program and be that much farther ahead when the permanent program is put in place. And I do think that is a significant carrot. I was, at the same time, impressed that FDA is suggesting that perhaps this certification program could make it unnecessary to file a 510(k) at all for certain presumably low risk digital health products. I think that's fantastic."

The FDA also formalized much of what Gottlieb wrote in his blog post last month in a "Digital Health Action Plan" published today by the industry. You can read that document here.