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FDA to start regulating health wearables

pharmafile | January 22, 2015 | News story | Medical Communications, Sales and Marketing Apple, FDA, Samsung, digital, wearables 

Any firms making exaggerated health claims of wearable devices face marketplace disappointment following new FDA guidelines.

The FDA has released draft guidance on how wearable devices for medical purposes could be regulated, and also rules that define and distinguish consumer wearables from serious healthcare technology.

Providing a wearable device falls into the ‘general wellness devices’ category it should be all plain sailing, the FDA says this includes technology that has “an intended use that relates to a maintaining or encouraging a general state of health or a healthy activity, or one that associates the role of healthy lifestyle with helping to reduce the risk or impact of certain chronic diseases or conditions”.

However, unless a firm wants to jump through a variety of regulatory hoops before finding itself on the wrong side of the marketplace (or even the scrapheap), then it should avoid such claims that the product will treat or diagnose obesity; an eating disorder; anxiety; autism; muscle atrophy or erectile dysfunction.

It gives further examples such as a claim to restore a function impaired due to a disease or deformity, so if a company says its prosthetic device enables amputees to play basketball when it doesn’t – that’s clearly off the cards.

Should a firm be able to prove a wearable health gadget is of a low risk to the public, and that it can also back claims to diagnose and even treat certain diseases, this will stand it in good stead along with receiving a lucrative FDA endorsement.

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.

Quite how these health-related rules will affect the eagerly-anticipated Apple watch that is shortly to be released (some say March) remains unclear, but according to web source Digital Trends Apple has met with the FDA multiple times over the last year to make sure its watch would meet all of the administration’s requirements, upon launch.

This move arrives as interest in mobile health wearables is gaining traction, but consumers want more from the market, citing affordable devices that offer greater engagement and also privacy.

Brett Wells

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