The recent boom in medical technology advancements have led to a breakout area in FDA's purview: wellness devices. They're not quite medical devices, but they're medical adjacent. So, what's the difference?
There are fine but important distinctions between medical devices and wellness devices, and it's enough of a growing area that FDA has recently come up with guidance documents regarding them. (Though understand that they still will exercise enforcement discretion when considering these devices.)
In simplest terms, if a device isn't trying to cure, mitigate, or treat any disease, it's not a classic medical device. A wellness device can monitor health-related stats or information, but it can't make any claims regarding what that information will or won't do in regards to treatment or diagnosis of any specific disease. For instance, Fitbits are a wearable device that might monitor steps taken, sleep patterns, and the like, but they won't - and can't - claim, for instance, that monitoring these stats equates to managing diabetes. Classifying them as a wellness device acknowledges that they have a general health and wellness benefit, but these benefits cannot claim to be disease-specific.
Per a recent draft guidance document, FDA defines a wellness device or product as one that is only intended for general health and wellness and which also presents a very low risk to the user, as such:
1. Devices that are intended only for general wellness use. This means that they're a) intended to be used in a way that relates to maintaining or encouraging a general state of health or healthy activity, or b) in a way that associates the role of healthy lifestyle with helping 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.
2. Devices that present a very low risk to users’ safety. Think commercially available wearables, software, video games, exercise equipment, audio recordings, and the like, not those that involve implants, body modifications, or medical procedures.
Some specific examples of what wellness devices can and cannot claim, as outlined in the document, are as follows:
Okay: Claims to promote or maintain a healthy weight, encourage healthy eating, or assist with weight loss goals.
Not okay: A claim that a product will treat or diagnose obesity.
Okay: Claims to improve mental acuity, instruction following, concentration, problem-
solving, multitasking, resource management, decision-making, logic, pattern recognition or eye-hand coordination.
Not okay: A claim that a computer game will diagnose or treat autism.
Okay: Claims to promote relaxation or manage stress when there is no reference to anxiety disorders or other reference to a disease or condition.
Not okay: A claim that a product helps treat anxiety.
Okay: Claims that address a specific body structure or function, such as to increase or improve muscle size or body tone, tone or firm the body or muscle, enhance cardiac function, or enhance or improve sexual performance.
Not okay: A claim that a product will treat an eating disorder, such as anorexia.
The language limitations leave it to the consumer to understand the implications of a wellness device's usage, and then decide how purposeful it is for them: wellness devices are tools, not treatments. Will monitoring your steps help you lose weight and get your diabetes under control? That's up to you, as the user (and your doctor), to decide.
Because these are limitations of language, FDA may use enforcement discretion to determine which devices are wellness vs. medical. That said, having a product classified as a wellness device without making claims of treating any disease may also provide an opportunity to have the device used, collect data, and then submit an application to be reclassified as a medical device, at which point the FDA can review and decide.
You can read more about how FDA classifies medical devices here.