FDA Releases Much Anticipated “Plan for Digital Health Devices”

We in the Mercer Health Innovation LABS were excited by the recent FDA announcement of the Pre-Cert for Software Pilot Program—a sea change in the way the FDA evaluates digital health solutions.

Following up in short order on his June 15th policy teaser (see my earlier post, here), FDA Commissioner Dr. Scott Gottlieb laid out his intention to move away from evaluations of individual digital health solutions, and instead focus on the evaluation of companies as a whole—leaving the door open for pre-certified developers to continually iterate on their digital health tools without fear of renewed regulatory scrutiny with each new software update. The FDA also opened up an application for companies to take part in a pilot program, the goal of which will be to set guidelines for the evaluation of low-risk digital health solution developers going forward.

Through this change in guidelines, the FDA is aiming to maintain its role as a consumer watchdog while lessening the administrative burden on developers for certification of low-risk digital health tools. By allowing companies to bypass the need for certification on each iteration of their software, the FDA is hoping to speed the delivery of beneficial healthcare solutions to the hands of those in need. Many employers see digital health solutions as key to providing the personalized experience that can engage employees across the health spectrum. With this change, we can all hope for more creativity and activity in the digital health community in the coming years.

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