Apple and Fitbit among the 9 companies selected for FDA’s coveted digital health pilot

Scott Gottlieb
FDA's Scott Gottlieb said the companies selected to the pre-cert program represent "various business models within the industry."

Some of the world’s largest technology companies will help shape the Food and Drug Administration’s innovative approach to digital health regulation through a new pilot program.

Apple, Fitbit, Samsung and Alphabet-owned Verily are among the nine participants selected for the FDA’s Software Pre-Cert Pilot Program, announced earlier this year as part of the agency’s broader Digital Health Innovation Action Plan to streamline the regulatory process for companies with a history of developing and testing quality products.

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The other participants include Johnson & Johnson, Pear Therapeutics, Phosphorus, Roche, Tidepool. Pear Therapeutics just received FDA approval for its mobile app designed to treat addiction, a first for the substance abuse industry.

“We carefully selected the final participants in this pilot program to create a group that represents the various business models within the industry—from large tech companies and traditional medical device manufacturers to small entrepreneurs,” FDA Commissioner Scott Gottlieb, M.D., said in a speech at the AdvaMed (MedTech) Conference, adding that the agency received 103 applications.

Bakul Patel, associate director for digital health in the FDA’s Center for Devices and Radiological Health, said the diverse selection of companies will allow regulators to review a broad range of performance indicators that will shape the industry's future.

“This feedback will be invaluable as we progress through the pilot and onto the next stages of digital health oversight,” he said in the announcement.

Gottlieb added that the opportunity to interact with the FDA during the pilot program is “still wide open” and the agency plans to hold informational calls open to the public. He said the agency plans to “deepen its understanding” of how these technologies operate to reduce the time and cost it takes to get innovative products to market.

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“This pre-cert framework is a modern approach to regulation—focusing on the product developer rather than just the product—that could have other applications across our portfolio,” he said. “For example, this construct could form part of the framework for a modern legislative approach to laboratory-developed tests.”

With the release of its new Apple Watch that can detect heart rate irregularities, Apple appears poised to go after a larger share of the healthcare market. During an event earlier this month, Apple COO Jeff Williams said the company has partnered with Stanford to test the device’s ability to predict atrial fibrillation.

Fitbit is set to release its own updated smartwatch with several health-related features. The company sees the pilot program as a way to broaden its use in the healthcare industry.

“As Fitbit takes a more integrated role in personal healthcare, we are hopeful this will allow us to accelerate FDA regulated features and software development, bringing new capabilities that could positively impact health outcomes to market more quickly,” Fitbit CEO James Park said in a release.

Bradley Merrill Thompson, a medical device attorney with Epstein Becker Green, said in an email to FierceHealthcare that the investment the nine companies will make in the pilot program signals a long-term commitment to class II medical devices, a classification that allows them to make medical claims. 

"There’s no point in doing this for only one product," he said. "The only way it makes sense to invest the time necessary in the pilot will be if you intend to be a long-term participant in the class II marketplace."

For those following Apple's encroachment into healthcare, it's a signal that "recent product announcements, as well as probably ones that have not yet been publicly shared, will be aimed at the class II level of claims," he added.

Thompson also acknowledged the huge opportunity for these companies to take part in an entirely new paradigm for medical device regulation.

"They will learn a great deal, develop relationships with FDA and probably influence the direction the program takes."

Editor's note: This story has been updated to include comments from Bradley Merrill Thompson.