Wellness Devices

Med Device Monday: Owlet Baby Vitals Monitor

Last week I talked about the distinctions between traditional medical devices and an emerging category called wellness devices. 

The Owlet baby monitor is an example of a wellness device that has potential to have a huge and life-saving impact. Per FDA's draft guidance document as discussed in that last post, Owlet doesn't (yet) claim to do anything except help you monitor whether or not your sleeping infant is breathing: they'll keep watch so you can sleep, too. Of course, this is pretty useful in itself. It takes existing technology (a pulse oximeter, like you might have seen in a hospital) and brings it into the home, paired with a simple alert device, and accessibility via your phone. Take a look:

So again, this is currently a wellness device, meaning that it isn't - and can't be - claiming to treat, cure, or mitigate any disease (read their disclaimer here). They've submitted an application to FDA and upon clearance the Owlet will then transition to being a medical device. Their disclaimer points out that this "device is not intended to cure, treat, or prevent...Sudden Infant Death Syndrome (SIDS)." That said, a benefit of this becoming a medical device (and therefore reimbursable by health insurance companies) seems to be an obvious and wise move for Owlet. 

SIDS is a type of SUID (Sudden Unexpected Infant Death). Per the CDC, "SIDS is defined as the sudden death of an infant less than 1 year of age that cannot be explained after a thorough investigation is conducted, including a complete autopsy, examination of the death scene, and a review of the clinical history. About 1,500 infants died of SIDS in 2014. SIDS is the leading cause of death in infants 1 to 12 months old. ...Even after a thorough investigation, it is hard to tell SIDS apart from other sleep-related infant deaths such as overlay or suffocation in soft bedding."

All of which is to say: If your baby isn't breathing in the middle of the night, Owlet is intended to alert you so that you can intervene. Watch more stories below.


These parents lost a child to SIDS. They later had another child and beta-tested the Owlet, with the motivation of their previous loss. Note that Owlet is not claiming to resolve SIDS. The emphasis is on Owlet being on duty when parents can't be. "The Owlet doesn't ever sleep, so you can."

This parent's child was born at two and half pounds, and was in the NICU for two months. "In the NICU she was always being watched over and had monitors, and we came home and it was very nerve-wracking to have a little tiny four pound baby at home." She goes on to talk about how the Owlet helped her intervene one night when her baby was silently choking, and the reassurance she feels in using it.

Wellness Devices vs. Medical Devices

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.