Just two months after announcing the applications for its pre-certification program pilot, the FDA has announced the nine companies that will be participating. The list includes major tech companies Apple and Samsung; health tech companies Verily, Pear Therapeutics, Tidepool, and Phosphorus; pharmaceutical companies Roche and Johnson & Johnson; and Fitbit — an interesting inclusion insofaras the most of the company's offerings are not FDA-cleared.
"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 today. "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."
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 more agile approach toward digital health technology that focuses on the software developer rather than an individual product."
Apple's inclusion on the list is interesting if not surprising given the organization's close past relationship with the FDA, which MobiHealthNews detailed last year in a series of exclusive stories based on emails exchanged between the agency and the company. One of the products mentioned in those emails is likely new software for the Apple Watch, announced at Apple's launch event earlier this month, which would allow the Watch to measure heart rhythms and even detect arrhythmias by applying algorithms to the heart rate data it collects.
But even beyond seeking clearance for its own devices (which likely include a diagnostic app for Parkinson's disease as well), the emails showed that Apple quietly participated in the shaping of FDA policy by securing a spot in a working group within the International Medical Device Regulators Forum. This forum created the draft document the FDA would later work off of in creating its own regulatory policies.
Samsung, another of the companies, has a number of FDA clearances because, in addition to consumer electronics, the company has a healthcare division that makes ultrasounds and CT scanners. But its worth noting that the company also has at least one mobile health-related clearance, which it received in 2014 for its S Health app.
Verily doesn't currently have any FDA-cleared devices, but it did notably hire Gottlieb's predecessor, former commissioner Robert Califf, earlier this year.
Pear Therapeutics is a notable inclusion on the list for the fact that it just last week received a landmark de novo clearance for ReSet, its digital therapeutic for non-opioid addiction.
Of all the companies on the list, however, Fitbit is the biggest surprise. While there has been a lot of speculation about Fitbit venturing into the regulated clinical space, CEO James Park has always been a little bit coy about the prospect.
"Look, I think it’s a pretty massive opportunity,” he said in an earnings call back in May 2016. “I think these devices are going to get increasingly more sophisticated over time, but there is obviously a lot of legal and regulatory challenges that we’re going to have to navigate. I think the great thing is that, due to our leadership position, we are very visible in Washington and I think we’re going to have a big seat at the table in driving those discussions, so it’s going to be a pretty big opportunity for us.”
Fitbit also took some heat way back in 2013 for not seeking FDA clearance for its Aria weight scale, even though other companies had pursued clearance for very similar products. Ultimately the scale did recieve FDA clearance, and later that scale would be included in a category of low-risk devices over which the agency exercises regulatory discretion.
(Correction: This article previously misstated the FDA status of the Aria weight scale.)
In a statement about joining the Pre-Cert program, Park gave a little more detail about the company's future plans.
“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,” Park said in a statement today. “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.”
According to the FDA, the companies will now provide the agency access to measures they currently use to develop, test, and maintain their software products, including ways in which they collect post-market data. Later on, the FDA will conduct site visits to learn about the company's quality management systems as well as their development processess.
