Understanding the Difference Between a General Wellness Device and a Regulated Medical Device - a podcast by Greenlight Gurus Jon Speer + Medical Device Quality Regulatory Leaders, Entrepreneurs, Consultants, R&D Engineers
from 2019-11-07T15:07:20
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.
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