When the Food and Drug Administration updated its guidance on devices for “general wellness” earlier this year, it didn’t just provide clarity for creators of apps and wearables. It opened the floodgates to an already massive and growing market.
Since then, top executives at major wellness companies have told me that they now plan to avoid developing the kinds of products that require FDA clearance. That burdensome work is no longer worth it for them since the agency expanded the kinds of products that can be sold outside of its regulations.
For companies that continue to create FDA-cleared devices, this creates a new imperative. We must work to clearly distinguish medical-grade technologies from the many wellness products inundating the marketplace. We must make the difference clear to all stakeholders, including consumers, healthcare providers, payers, investors, and more.
To understand why, we first need to dig into the guidance itself.
The ‘general wellness’ category
Under FDA rules, “general wellness” products do not require authorization to be sold to the public. So the key for creators is to determine what exactly counts as “general wellness.” The new guidance answers that question.
A “general wellness product” may help to “reduce the risk or impact of certain chronic diseases or conditions and where it is well understood and accepted that healthy lifestyle choices may play an important role in health outcomes for the disease or condition,” the document explains.
The FDA “may consider certain products that use non-invasive sensing (e.g. optical sensing) to estimate, infer, or output physiologic parameters (e.g. blood pressure, oxygen saturation, blood glucose, heart rate variability) to be general wellness products when such outputs are intended solely for wellness uses.”
“Products are not general wellness products when they are intended to measure, estimate, or report physiologic values for medical or clinical purposes, including screening, diagnosis, monitoring, alerting, or management of a disease or condition,” the FDA says. They may not include “claims, functionality, or outputs that prompt or guide specific clinical action or medical management” or “values that mimic those used clinically.”
Amanda K. Sarata, specialist in health policy for the Congressional Research Service, said the new guidance “somewhat expands the scope of products” that may qualify as general wellness. Some other analysts, like attorneys at law firm Ropes & Gray, said the new guidance “significantly” expands the scope.
While the FDA guidelines are officially “nonbinding recommendations,” the industry generally follows them very carefully.
Consumers vs. patients
When considering what devices to use and how, most people don’t know the difference between “general wellness” products and those that go through all the rigor of FDA clearance. They may not know the myriad benefits of using FDA-approved devices.
They need to. These tools are designed to save lives and address medical dangers. The more people use them, the more diseases and conditions could be spotted early on.
That takes education. Those of us working on these kinds of technologies should work to help the public see the distinction. One way to do it is to emphasize that “medical-grade” technology goes beyond “wellness.” We can also highlight the importance of clinical AI. As the MIT Jameel Clinic explains, this emerging field uses new technologies “to improve medical diagnosis, treatment, and prevention of diseases. It aims to enhance medical decision-making, optimize treatment plans, and enable personalized medicine to empower clinicians to improve patient outcomes.”
For users of these products, one way to think of the difference is to focus on their own roles. When using general wellness tools, they are consumers. When using medical-grade tools, they’re patients. I want people to know when they become patients. That awareness can help them increase their commitment to using devices as intended, tracking results, and discussing the findings with their doctors.
We should work quickly to clarify this distinction. The “health and wellness devices market” is estimated at $123 billion this year in the United States alone, and is expected to reach $222 billion by 2033, according to Persistence Market Research. As consumers are inundated with new health tech products, they risk feeling lost in a sea of options.
Our responsibility is to build a safe harbor — a space where people know they are using rigorously tested, clinically validated technology hand-in-hand with their doctors. It is no exaggeration to say that the faster we do so, the more lives we will save.
Author bio:
Dr. Dave Albert is founder and chief medical officer of AliveCor, the leading provider of FDA-cleared personal electrocardiogram (ECG) technology. Alivecor is transforming cardiology with its medical-grade AI-powered solutions including Kardia devices, the most clinically validated personal ECGs. The Kardia 12L, designed exclusively for healthcare professionals, is a 12-lead ECG system that expands access to clinical grade ECG diagnostic capabilities across a variety of acute care settings.
An Oklahoma native, Dr. Albert graduated with Honors from Harvard College and from Duke University Medical School. He went on to create multiple successful tech startups, and served as chief scientist of GE Cardiology A physician and inventor, Dr. Albert holds more than 80 issued U.S. patents, and has authored or co-authored more than 100 scientific abstracts and publications.
Photo: metamorworks, Getty Images
