FDA to ease healthcare wearables oversight

The FDA announced that "low-risk general wellness products," including healthcare wearables and software intended to promote a healthy lifestyle, will no longer be subject to stringent medical device regulation.

The agency issued guidance on Jan. 7 to clarify the FDA's stance on general wellness products, noting that these tools "are not subject to the FD&C Act's [Federal Food, Drug, and Cosmetic Act's] regulatory requirements for devices."

The guidance divides the general wellness products into two broad categories. The first category includes products that do not reference disease or medical conditions, such as those claiming to promote healthy eating and physical fitness, manage stress, improve mental acuity and support sleep management.

The second category includes products that aim to promote healthy lifestyles and claim they may help reduce the risk of certain chronic diseases or assist people in better managing these diseases. For instance, a product that encourages eating a balanced diet, maintaining a healthy weight and getting adequate sleep could support type 2 diabetes management.

Additionally, the FDA may consider some products that use non-invasive sensing to be general wellness products when the physiologic data they gather is intended only for enhancing wellness.

During a Fox Business interview, FDA Commissioner Marty Makary, M.D., stated that the FDA wanted to be "proactive" amid the AI revolution.

"We want to let companies know, with very clear guidance, that if their device or software is simply providing information, that they can do that without FDA regulation," he said. "The only stipulation is if they make claims of something being 'medical-grade.'"

Tools claiming to diagnose, treat, cure, or prevent diseases and making clinical-grade accuracy claims will be required to undergo the usual stringent approval process reserved for medical devices.

When asked about enforcing accuracy with regard to non-medical grade or general wellness products, Makary said, "Let's let the market decide, let's let doctors choose from a competitive marketplace which ones they'd recommend for their patients."

The statement aligns with the Trump administration's overarching deregulatory stance toward AI and other emerging technologies in healthcare.  

HHS Secretary Robert F. Kennedy, Jr., applauded this regulatory shift on social media.

"The @US_FDA is unlocking wearable devices for general wellness that have, for too long, been tied up in red tape," he wrote on X. "Wearables can help everyday Americans proactively take charge of their health, helping them steer clear of expensive interventions and chronic disease."

Anuja Vaidya has covered the healthcare industry since 2012. She currently covers the virtual healthcare landscape, including telehealth, remote patient monitoring and digital therapeutics.