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Smart Fabrics as FDA 510(k) Devices – Moving Beyond Consumer Gadgets

Interest in fabrics and textiles that incorporate sensors into the fabric and can detect and measure parameters such as body temperate and heart rate have become the new generation of adult toys, joining ‘smart’ watches and similar gadgets. This generation of smart clothing allows users to view data from the sensors on their smart phones and/or Apple/Fitbit devices. But a separate group of companies is emerging, those who are marketing smart fabrics as FDA 510(k) devices.

There are close to one hundred companies active in this market, a testimonial to the low barrier to entry. As a result, competition for sales can be fierce. A secondary business concern is the inevitable drop off in interest as the novelty factor wears off.

smart fabrics as FDA 510(k) devicesThere is, however, another tier of competition – smart fabrics as FDA 510(k) devices – those that have pursued the medical device track, designing and testing their products through the clinical trial process. Market participants that successfully navigate this path can receive marketing authorization – approval to market their products as medical devices for specific indications – under the FDA’s 510(k) authorization.

While the FDA approval process incurs more expense, risk and effort, success represents membership into a rather exclusive club. Of the companies competing for Smart Fabric market share, less than ten percent have at least one FDA approved medical device among their product portfolio.

As the competition continues to intensify for the average consumer/user, we expect the number of players developing and marketing wearables to examine the benefits of FDA approval.


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