USA – No, a Wellness Device Can’t Save Your Life (not Directly, Anyway)

Be sure to understand the distinction between medical devices and wellness devices.

It’s no surprise that a large number of wellness devices are being developed to allow today’s tech-savvy patient-consumers to take charge of their own health. Wellness devices are a great way to empower people by giving them access to data. However, it’s vital to remember that unlike medical devices, they are not required to be proven to be safe or effective. The responsibility and choice to claim a device as either wellness or medical lies completely with the manufacturer. It is extremely important that manufacturers understand the rules. Mistakenly seeking FDA approval for a wellness device might be costly, but not seeking FDA approval for a medical device could be a deadly.

What’s the difference?

Medical devices require a much higher standard of design, design control, and testing than is necessary for a wellness device. This is all risk-based: a wellness device can’t be responsible for high-risk, life-saving actions. In fact, they are defined as being at low risk to cause patient harm.

Wellness and Mobile Apps

A number of wellness devices are software programs that run on smartphones and other mobile communication devices. They can also be an accessory or a combination of accessories and software. If these devices are medical devices, then they are called Mobile Medical Apps, otherwise they are simply referred to as mobile apps.

Can a Device be Both a Wellness and Medical Device?

A specific product line is typically one or the other, but a family of devices may include both. For example, a device can measure heartrate for wellness purposes, and the manufacturer could also develop a medical version with a similar architecture for acute care applications. Devices that jump between wellness and medical indications often fall into one of two categories:

  • Wellness-first business model: creating a first-gen device as a low-barrier-of-entry first-step to market for companies seeking to eventually make their way to an FDA approved product. In these cases, the manufacturer (typically) releases a product as a wellness device with a clearly non-medical indication for use (e.g., “supports an active lifestyle,” or “promotes self-health”) before releasing generation-two with a more specific, medical indication for use (e.g., “used to diagnose sleep apnea”).
  • FDA confidence marketing model: A marketing strategy is to create a device for improving wellness that is also FDA approved. In this case, it’s a wellness-indicated device trying to gain confidence from their consumers by getting FDA clearance, despite being technically unnecessary. Their manufacturers are simply choosing to submit to FDA to increase sales and prove they have developed a safe and effective device.