Fitbit Amongst Others For The Digital Health Software Pilot Program
The FDA has now announced companies selected to participate in a first-of-its kind pilot program that will help revolutionize digital health regulation which includes leaders and innovators in the medical device and technology sectors.
From over a 100 applicants, the companies to participate in the Software Precertification (Pre-Cert) pilot program are: Apple, Fitbit, Johnson & Johnson, Pear Therapeutics, Phosphorus, Roche, Samsung, Tidepool, and Verily.
“We previously said that the digital health pilot will include nine companies. We’re announcing those companies today,” FDA Commissioner Dr. Scott Gottlieb said in remarks at the AdvaMed MedTech Conference in San Jose, California. “We’ve had 103 applicants to date. 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.”
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.The FDA is trying to make it easier for consumers to have access to approved health devices and programs so that each individual can take more responsibility for their own health. Consumers already use wearable devices and health apps to assess general health and specific medical conditions, even though most of these devices do not bear an FDA-approved stamp. The companies participating in this pilot program will help the FDA narrow down “key metrics and performance indicators for precertification” surrounding a company’s digital health software.
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, then it won’t need to regulate each product from that firm.
“Our method for regulating digital health products must recognize the unique and iterative characteristics of these products,” Gottlieb said in a statement. “We need to modernize our regulatory framework so that it matches the kind of innovation we’re being asked to evaluate, and helps foster beneficial technology while ensuring that consumers have access to high-quality, safe, and effective digital health devices. These pilot participants will help the agency shape a better and agiler approach toward digital health technology that focuses on the software developer rather than an individual product.”
“We applaud the FDA for taking a progressive and thoughtful approach to designing a potential new digital health regulatory framework and are proud to have been selected to participate in this innovative pilot program,” said James Park, co-founder and CEO of Fitbit. “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.”
However, the devil is in the details. How strict will the FDA be when assessing algorithms that enable heart rate monitoring in wearables? How accurately do monitors have to measure pulse in order to be labeled “accurate” by the FDA? It’s also unclear how often precertified companies would be required to update the FDA about changes in their health software. Overall, this seems like a step in the right direction for both the FDA and digital health companies—but we should still be wary when faced with a consumer device making medical claims.
