Medical Devices Regulation

Does your FitBit need to be FDA approved?

Right now, the answer is no, but in the near future, this may no longer be the case. The FDA has released a draft guidance on how it will regulate the new generation of wearable technology.  This guidance  says it will not regulate “general wellness” products like the FitBit.

However, if the wearable cites health benefits for a specific disease, then the wearable would be subject to FDA regulation. For instance, if the wearable states it can improve specific disease symptoms or improve functional status due to a specific deformity, those claims would require FDA approval.

On the one hand, having commercial firms make false advertisements is problematic.  On the other hand, the FDA approval process is expensive and time-consuming for innovators.  Since many firms entering the wearable space are start-ups, they may not have the funds to go through FDA approvals.  Further, if wearables undergo revisions due to user feedback or beta testing, would the improved version of the product also have to go through FDA approval?  Requiring innovation

Pharmafile notes that “The FDA guidelines are not yet legally binding it is important to note, and the US regulator is requesting opinions from the public on the move.”

Individuals who see government as getting in the way of innovators likely will think the FDA has overstepped its role; individuals who see government as protecting the general public may think that the FDA has not gone far enough.

Another question is even if the FDA decides to regulate wearables, does it even have the capacity to do so effectively?  Given the large number of health-related wearables entering the market, the FDA’s good intentions could risk significantly stifling innovation.

1 Comment

  1. Currently, are Wearables that have some medical benefits elegible for billing with insurance companies?

    Also, what is the criteria for determining if a Wearable device must be certified with the FDA?

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