The FDA has partnered with some of the biggest names in health and technology to modernize consumer health devices and programs. The agency just announced the companies who will be the first to participate in its precertification pilot program under its Digital Health Innovation Action Plan. Apple, Fitbit, Samsung, and Johnson and Johnson are among the nine companies included in the program, meaning they will collaborate with the FDA to create guidelines for other companies to get FDA precertification based on their digital health programs.
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.
Software is key to this program because the FDA isn’t looking at individual devices made by these participating companies. Rather, the FDA will consult with Apple, Fitbit, and others about what aspects should be included in a company’s digital health software in order for it to be “pre-certified.”
What could come after the FDA establishes precertification rules is intriguing. According to the FDA’s original blog post about the pilot program, precertified companies could submit less information to the FDA than ever before when seeking approval of a new digital health tool. In some cases, a precertified company may not have to submit any information at all—it could launch the tool immediately and begin collecting data. “Pre-certified digital health companies could take advantage of this approach for certain lower-risk devices by demonstrating that the underlying software and internal processes are sufficiently reliable,” the blog post reads. Essentially, if a company’s health software is approved, any device running on that software could be quickly (or immediately) considered approved by the FDA as well.
The FDA is generally open to working with new, innovative companies in the consumer health space. However, tackling the digital health market has been a challenge. Between all the wearable devices and dedicated health apps now available for any consumer to use, the FDA wants and needs to provide guidance to developers on how to make better, more accurate programs. This pilot program seems to be the FDA’s latest effort to provide that guidance.
The participating companies agreed to give the FDA “access to measures they currently use to develop, test, and maintain their software products” as well as let FDA officials perform on-site visits. The final guidelines for precertification will consist of rules created by the FDA with input from Apple, Fitbit, Samsung, and the other pilot companies.
While there’s no time frame for the precertification guidelines to be released, this could mean big things for consumer wearables and health apps in the future. The success of this program could make it easier for companies like Apple and Fitbit to produce “FDA-approved” devices, marketing them as certified medical devices. However, this doesn’t mean those tools will be more accurate or medically sound than before. The FDA doesn’t regulate medical devices as much as it does drugs, due to a different laws governing devices. Over time, lobbying has made it easier for devices to get the FDA’s approval, even if the device poses serious safety or efficacy concerns.
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.