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

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...
Source: MDDI - Category: Medical Devices Authors: Tags: Regulatory and Compliance Source Type: news