The FDA is working with some of the biggest names in health and technology to modernize consumer health devices and programs. The agency just announced the companies that will be the first to participate in the pilot pre-certification program under the Digital Health Innovation Action Plan. Apple, Fitbit, Samsung, and Johnson and Johnson are among the nine companies participating in the program, meaning they will work with the FDA to create guidelines for other companies to gain FDA pre-certification based on their digital health programs.
The FDA is trying to make it easier for consumers to access approved health equipment 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, although most of these devices do not carry an FDA-approved stamp. The companies participating in this pilot program will help the FDA refine “key metrics and performance indicators for pre-certification” around a company’s digital health software.
Software is key to this program because the FDA does not look at individual devices made by these participating companies. Instead, the FDA will consult with Apple, Fitbit and others about what aspects should be included in a company’s digital health software to ensure it is “pre-certified.”
What might come after the FDA enacts pre-certification rules is intriguing. According to the FDA’s original blog post about the pilot program, pre-certified companies were able to submit less information to the FDA than ever before when applying for approval for a new digital health tool. In some cases, a pre-certified company does not need to submit any information at all – it can launch the tool immediately and start collecting data. “Pre-certified digital health companies could benefit from this approach for certain lower-risk devices by demonstrating that the underlying software and internal processes are sufficiently reliable,” the blog post reads. If a company’s health software is approved, any device running on that software can soon (or immediately) also be considered FDA approved.
The FDA is generally open to partnering with new, innovative consumer health companies. However, tackling the digital health market has been challenging. Among all the wearable devices and specialty health apps now available to every consumer, the FDA wants and needs to guide developers to create better, more accurate programs. This pilot program appears to be the latest attempt by the FDA to provide that guidance.
The participating companies agreed to allow FDA “access to measures they currently use to develop, test, and maintain their software products,” and to allow FDA officials to conduct site visits. The final pre-certification guidelines will consist of rules created by the FDA with input from Apple, Fitbit, Samsung and the other pilot companies.
While there is no time frame for the publication of the pre-certification guidelines, it 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 and market them as certified medical devices. However, this does not mean that those tools will be more accurate or medically sound than before. The FDA doesn’t regulate medical devices as much as drugs, because of different device laws. Over time, lobbying has made it easier for devices to gain FDA approval, even if the device poses serious safety or efficacy risks.
The devil is in the details. How strict will the FDA be in reviewing algorithms that enable heart rate monitoring in wearables? How accurately do monitors have to measure heart rate to be labeled “accurate” by the FDA? It’s also unclear how often pre-certified companies must notify the FDA of changes to their health software. Overall, this seems like a step in the right direction for both the FDA and digital health companies, but we still need to be wary when faced with a consumer device making medical claims.