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The FDA will not regulate your Apple Watches and Fitbits

US regulator clarifies its health wearables stance in draft guidance

Apple Watch 

Wearable fitness trackers and other devices that are only aimed at general wellness, and pose a very low safety risk to users, will not be regulated as medical products in the US.   

That's according to new FDA guidance, which comes ahead of the release of the Apple Watch (pictured), whose launch this year is expected to help boost overall wearable technology sales to 91.3 million units in 2016.  

The US regulator said it has been getting a steady stream of inquiries about whether particular products count as devices under the Federal Food, Drug & Cosmetic (FD&C) Act.  

Moved to act the FDA has confirmed that its Center for Devices and Radiological Health “does not intend to examine low risk general wellness products to determine whether they are devices” under the Act.  

Issued last week, the FDA's draft General Wellness: Policy for Low Risk Devices guidance will, once finalised, represent the US regulator's “current thinking” on the topic - in other words, it won't establish legally enforceable responsibilities.  

The recommendations cover products that promote a healthy lifestyle, rather than drugs, biologics, dietary supplements and so on.  

Such products could include wearable technology, exercise equipment, audio recordings, video games, software programs and other products that are often, though not exclusively, available from retail outlets.  

By 'wellness products' the FDA is looking at those that help maintain or encourage a general state of health or a healthy activity, or associate the role of healthy lifestyle with helping to reduce the risk or impact of certain chronic diseases or conditions.  

As examples of such products the FDA said they might encourage healthy eating, promote physical fitness or improve mental acuity.  

But the regulator was clear that products which make treatment claims, and its examples included obesity, anxiety, autism and erectile dysfunction, could not be counted as making general wellness claims.  

The recommendations will now undergo a three-month consultation process, during which time comments and suggestions can be submitted online or by post to the regulator.

30th January 2015


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