Understanding the Difference Between a General Wellness Device and a Regulated Medical Device

Today Jon Speer and Mike Drues are going to be discussing general wellness devices. Mike is the president of Vascular Sciences, and he’s a guru on all things regarding compliance and medical device development. General wellness device development is relevant right now because they’re so popular and widely used in today’s health-conscious population. It’s important to understand what a general wellness device is, when it becomes a regulated medical device, and how the two are different when it comes to FDA regulation. Some of the highlights of the show include: - The FDA’s definition of a general wellness device, as well as Mike’s simpler definition. - What makes a wellness product low-risk, and what “low-risk” really means when it comes to both causing harm and the potential for providing incorrect information. - How to know if you’ve crossed a line with your wellness device and actually need to classify your product as a regulated medical device. Mike also gives examples to paint the difference more clearly. - How marketing a wellness device as a 510k can be beneficial for label expansion purposes, as well as how marketing it first as a wellness device can improve the 510k process -- with a caveat as to how to handle the submission. - The importance of prudent engineering with wellness devices; the lack of regulation is not an excuse to cut corners or take shortcuts.