In what can only be described as a pretty revolutionary move, the U.S. FDA is looking to change how it reviews mobile apps and digital health software to accelerate the regulatory process and get these products out there for people to start using ASAP.

In late July, the agency announced a Pre-Certification for Software Pilot Program that would evaluate and dub certain companies as “trustworthy,” to give their products the needed regulatory nod without the usual protracted regulatory review.

Now, the FDA has chosen nine companies (out of more than 100 applicants) to be part of the initial pilot program.

Notably for our Diabetes Community, seven of the nine the companies have direct ties to diabetes:

  • Fitbit: The smartwatch and health-tracker company that just recently teamed up with Dexcom, and is also working with Medtronic and others in the healthcare and diabetes app space;
  • Johnson & Johnson: Which obviously has a longstanding presence in diabetes with its OneTouch, LifeScan and Animas products (though the company has been “strategically evaluating” the future of those divisions);
  • Roche: As with J&J, this goes beyond just diabetes but it’s significant given the Accu-Chek Connect developments over the years and the recent acquisition of the mySugr platform for diabetes data;
  • Samsung: The consumer electronic giant based in South Korea that’s become active in healthcare, notably partnering with Medtronic to develop next-gen smartwatch connectivity that includes CGM data display;
  • Tidepool: The non-profit startup in Palo Alto that came on the scene in 2014 and has changed the conversation around open D-data and creating a new way to upload various diabetes devices into a single hub in the cloud;
  • Verily (formerly Google Life Sciences): Google’s health spinoff that is most well-known in the diabetes space for partnering with Dexcom to create next-gen CGM sensor that will be the size of a dime.

The other two companies chosen for the FDA pilot program are Pear Therapeutics in Boston, that designs prescription digital health tools for various conditions, and Phosphorus in New York, a biochemical company that focuses on the human genome and related sofware and data platforms.

Really, if you look at the list, diabetes certainly stands out as a focus.

A Needed FDA Fix

“I’ll do my best to not over-hype it, but I think this is a pretty big deal,” says D-Dad Howard Look, founder of the non-profit open-data startup Tidepool that was chosen for this pilot. “This is the FDA acknowledging that the old guidance for how software technology is regulated wasn’t working, and that it just couldn’t keep up with the pace of innovation we’ve been seeing in Silicon Valley and the consumer world.”

No wonder FDA was overwhelmed, given that estimates show last year 165,000 health-related apps were available for Apple or Android smartphones. Forecasts predict that such apps would be downloaded 1.7 billion times by the end of 2017.

What this new pilot program means is that the FDA is working toward a whole new framework for evaluating mHealth companies and software in a world where things move incredibly quickly.

This follows the landmark FDA decision in 2015 to change its approach to regulating mobile apps in healthcare by classifying many as “low-risk, non-medical function” items. This had an impact on the Dexcom G5 Mobile at the time – allowing faster approval. This also comes on the heels of long-awaited medical mobile app guidance and interoperability guidance from FDA.

“This is part of a long stream of decisions by the FDA acknowledging that they need to think differently in order to allow for innovation to proceed,” Look says.

How Companies & PWDs Will Benefit

“This new program embraces the principle that digital health technologies can have significant benefits to patients’ lives and to our healthcare system by facilitating prevention, treatment, and diagnosis; and by helping consumers manage chronic conditions outside of traditional healthcare settings,” FDA Commissioner Scott Gottleib wrote in a July blog post previewing this program.

When we asked what the FDA sees this meaning for the average PWD (person with diabetes), an agency spokeswoman responded: “Consumers will benefit the most from this pilot program; they will have timely access to innovative digital health products.”

For Tidepool, this means they’ll be invited to a series of meetings with FDA officials throughout multiple phases of the program, with the goal of helping the agency better understand how groups like Tidepool build their software.

Indeed, the FDA’s requirements for pilot program participants were all about “opening the kimono” on the development process:

  • The company must be in the process of developing or planning to
    develop a software product that meets the definition of a medical
  • The company must have an existing track record in developing,
    testing, and maintaining software products and demonstrating a culture
    of quality and organizational excellence measures that are tracked by
    Key Performance Indicators (KPI) or other similar measures;
  • And during participation of the pilot, companies must agree to:
    • Provide access to measures for developing, testing and maintaining
      software products and demonstrating a culture of quality and
      organizational excellence measures by KPI;
    • Collect real-world post-market data and provide it to FDA;
    • Meet with FDA for real-time consultation;
    • Be available for site visits from FDA officials; and,
    • Provide information about the firm’s quality management system.


Look says all that was a no-brainer for Tidepool, as it’s how the organization has worked with FDA since the very start.

“I get very frustrated with companies that say the FDA is the bottleneck, because they don’t believe they are,” he says. “If you engage early and often, they want to help you move quickly through the process.”

Tidepool learned so quickly that Look recalls Stayce Beck of FDA once telling him he should go give talks at other medical device startups about how to best work collaboratively with the FDA.

The new pilot program is meant to codify that kind of collaboration into actual working protocols between the agency and companies.

A Three-Phase Rollout

Three phases are envisioned at the moment: pre-certification, framework for streamlining the approval process, and then post-market selection of data. After the first phase this Fall, the FDA expects to hold a public workshop in January 2018 to go over initial findings.

Look says participants were told to expect that each of the three phases could last 4-6 months, meaning final draft guidance on all of this could be ready for publication at some point in early 2019.

He sees this as being beneficial for public health, with diabetes being very much front and center. In particular, he sees it as very notable that companies like Google and Apple and Samsung are on the list along with traditional therapeutic and medical companies like Roche and JnJ.

“It’s another sign that the medical health-tech and consumer electronics worlds are colliding in a big way,” he says.

DOC Thanks FDA

From our POV as hosts of the bi-annual D-Data ExChange (diabetes tech leaders) forum for the past five years, we believe the D-Community should stand up and take notice here of how much of an ally the FDA has become. We’ve not been shy about saying that before, and we echo it again — especially in light of recent approvals of groundbreaking new technology and treatments here in the U.S., and establishing the first-ever FDA Patient Engagement Advisory Committee that includes well-known DPAC advocate Bennet Dunlap (their first meeting is set for Oct. 11-12).

We also have to give huge kudos to Drs. Courtney Lias and Stayce Beck of FDA, who just received some much-deserved national recognition for all their regulatory work on getting the first closed loop (pre-Artificial Pancreas) technology to market here in the States, among other things.

Way to go, FDA! Thanks for all you’re doing to streamline the regulatory process and therefore make life better for PWDs and all patients!