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FDA Guidance - general wellness products - wearables

Has anyone got experience with categorising products as a general wellness product rather than medical device.
I have a few questions:

1. Does the manufacturer self-declare that their product is part of the general wellness category?
2. Can manufacturers use the general wellness exemption for a product that could be interpreted to be similar to devices that have a classification regulation? For example, an oximeter, thermometer, breath counters, etc.
3. The guidance says that inclusion under the policy does not establish that is has been shown to be safe and/or effective for its intended use, are there any FDA recommendations for manufacturers to consider when determining how they want to show safety and effectiveness of a general wellness product?


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First, I would suggest you consult with a professional Regulatory Affairs person (I'm not).

As far as I know, there's no formal self-declaration required. It's essentially just a consumer product. There are other agencies that may have a play; e.g., FCC if you have wireless communication, FTC for general consumer protection, etc.

Once you get into oximeter and thermometer measurements, though, you may be crossing the line. (Again, an RA pro can help.)

As far as safety and effectiveness, I believe that's your call if it's outside the scope of a medical device. Off the top of my head, I can think of a number of things:
  • population for the intended use (and that it consistently works across the population; e.g., youth, adults, sex, ethnicity, etc.)
  • the spectrum of environmental conditions (heat, cold, humidity as well as other factors like sweat, impact, etc.)
  • accuracy of any measurements (across the population and environmental conditions)
  • whether it is interfering with anything (like a pacemaker) and whether anything (like a cell phone) is interfering with it.
Hi Mike,
Just getting recently reacquainted with Elsmar Cove since its revival. Judging by the date of your post, you may have gotten these questions answered elsewhere
The short answers are:
1 - Yes.
2 - No.
3 - Doesn't apply. (Great job by Yodon with fleshing this out with what you might want to gather as part of your internal product risk management dossier.)
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