The regulation of General Wellness Devices
In recent years, there was a big increase in the distribution of general wellness devices. In fact, there was the need of a guideline from regulatory agency to clarify the classification of these devices. For example, the Australian regular published a guideline for general wellness devices.
Specifically, the regulations for these devices is quite unclear. It is often difficult to decide if these devices meet the definition of medical devices or not.
In September 2019 FDA published a new guideline on the regulation of general wellness devices. This brings more light in the direction to have a precise regulation for digital health medical devices. Furthermore, these new regulations go in the same direction of the so-called FDA pre-cert program. It is an FDA program to facilitate the market approval for Software-related medical devices.
FDA considers general wellness produces all the devices with these two characteristics:
- devices that are only general wellness use (as defined in this specific guidance), and
- there is a low risk to the safety of users and other persons.
Devices for sustaining general improvement to functions associated with a general state of health that do not make any reference to diseases or conditions stay in this first category.
Instead, in the second category there are the devices that help to sustain or to offer general improvement to functions associated with a general state of health while making reference to diseases or conditions. In this case there two other possibilities:
- the intended use of the device is to promote, track, and/or encourage choice(s), which, as part of a healthy lifestyle, may help to reduce the risk of certain chronic diseases or conditions
- intended use is to promote, track, and/or encourage choice(s) which, as part of a healthy lifestyle, may help living well with certain chronic diseases or conditions.
The risk determination of wellness devices
As we know, the concept of risks play a fundamental role in medical device standards and regulations.
In order to determine if the devices present a low risk to the safety of user or other person, these are criteria/questions :
- Is the product invasive?
- Is the product implanted?
- Does the product involve an intervention or technology that may pose a risk to the safety of users and other persons if specific regulatory controls are not applied, such as risks from lasers or radiation exposure?
The agency anyway suggests to check the classification (medical devices or not) of similar devices with similar intended use. In this way it is possible to have a more precise idea on the hypothetical classification.
In conclusion, thanks to this FDA guideline there is more light in the regulation digital medical devices. This facilitates the manufactures in the classification of wellness devices. The classification of these devices, in fact, is not always straightforward.
If you want to have a more precise overview of the current trend for FDA regulation, refer to this post!
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