Should Wellness Products Come with a Warning?

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we’re speaking about a recent Editor’s Letter I wrote for MPO that gave reasons why placing a warning label on wellness devices about their status as an FDA regulated medical device would be a good idea. Does Mike agree? Do you agree that patients should be provided with an explanation that a wellness product does not get reviewed or approved by the FDA? During this conversation, the following questions are addressed:

• My editorial is about wellness products. Before discussing further, can you remind us what a wellness product is?
• Why did you write this column and given wellness devices have been “formally recognized” by FDA since 2016, why did you write it now?
• In your title, you use Wellness Products vs. Wellness Devices. Why?
• You point out in your editorial that general wellness devices are low risk devices. In fact, that’s part of the title of the guidance. But is it correct to say, “General wellness devices are low-risk devices”?
• Let’s discuss the example from my editorial (SaltAir by Halosense).
• Should wellness devices be required to have a disclaimer regarding their lack of FDA review, or should it be the consumer's responsibility to research and find out more about the product on their own?
• If a disclaimer is recommended (maybe not required), what should the disclaimer say?
• What else is important?
• What are today’s takeaways?

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