Understanding the Difference Between a General Wellness Device and a Regulated Medical Device
Nov 07, 2019•31 min•Ep 45•Transcript available on Metacast Episode description
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.
