FDA signals softer stance on health devices—here's what that means for your practice

The FDA has issued new guidance on “general wellness products.” ^[] Experts say the guidance, which concerns low-risk items that promote health and wellness, appears to signal an easing of regulations on certain devices and products.

“The guidelines for general wellness products are quite benign and reflect the general focus of the current administration on promotion of [a] healthy lifestyle and reduction in regulatory complexity. I think these represent good guidance. We don’t need the federal government to be regulating fitness trackers or apps that help people to relax or sleep better,” Jorge Nieva, MD, a medical oncologist at USC Norris Cancer Hospital, tells MDLinx.

The new guidance

Under this guidance, general wellness products are low-risk products intended solely for general wellness use. These may include software programs, video games, audio recordings, and exercise equipment commonly available from retail establishments. ^[]

Thomas Kingsley, MD, Director of Applied Artificial Intelligence at UCLA Health, says that while some have regarded the updated guidelines as significant, real changes are minor.

“It’s fair to say that regulatory oversight has loosened, but I would frame this more as a formal alignment with how these products were already being handled in practice. While the FDA’s announcement initially sounded like a sweeping change, the actual updates in terms of wellness products are relatively modest once you read the fine print of the revised language,” Dr. Kingsley tells MDLinx.

“The updated guidance allows products to reference diseases in the context of monitoring or general awareness, as long as those references are clearly framed around wellness rather than treatment, diagnosis, or prevention,” he adds.

Easing regulations carries risk

The updated guidance does not apply to drugs, biologics, dietary supplements, cosmetics, or foods regulated by other FDA Centers or to combination products. ^[]

But some experts argue that there are still risks to easing regulations.

“It shouldn’t come as much surprise that the current administration—with its focus on less government regulation, fewer government employees, and lower government costs—would institute guideline changes to achieve those results. While these goals may seem generally laudable, it is important to keep in mind the potential risk of software and devices to understand the benefits that government regulation may offer,” David Cutler, MD, a board-certified family medicine physician at Providence Saint John’s Health Center in Santa Monica, CA, tells MDLinx.

“What seems clear to me is that the FDA Commissioner, who answers those questions, should have the safety of the public as his highest priority and not the [interests of] industry developers, their financial backers, or their political supporters. Public health—not maximizing profit or populist rhetoric—should be prioritized. The fact that these changes were made without any opportunity for public comment suggests that many of the impacts on public health may not have been addressed,” Dr. Cutler says.