Humans have already entered the era of smart phones, but the electromagnetic radiation of mobile phones is still a lingering topic for the health risks brought by the human body. In the era of smart wearable devices, electronic products will be "close" to consumers for a long time, and electromagnetic radiation and other sensors pose health risks, which also caused consumer anxiety.
According to TheVerge, a US technology news website, the US Food and Drug Administration (FDA), the world's most authoritative health and health agency, recently issued a device regulatory guidance document that includes the current popular sports bracelets as low-risk devices. The FDA does not strictly regulate this product.
For the technology industry, this FDA policy has also created a more relaxed policy space for the development of wearable devices. Otherwise, according to the past, the supervision and compliance process of health products will consume a lot of time and effort.
According to the FDA's definition, low-risk devices are not "aggressive" to human health, do not involve lasers and electromagnetic radiation, and do not introduce new problems in use and biocompatibility.
Many consumer electronic devices commonly used in life often have some negative health effects on consumers, so they are not listed as low-risk devices by the FDA. For example, sun lamps used for tanning skin may cause cancer risks due to ultraviolet rays. Some fillers used in cosmetic surgery may present a risk of rupture in the body.
In the FDA's management catalog, sports bracelets or health bracelets are included in products that improve people's health. These products encourage people to control their body weight, improve their health, relieve stress, encourage self-esteem, and improve sleep quality.
It should be emphasized that most of the current sports bracelets only provide functions such as heart rate, blood pressure monitoring, sleep monitoring, walking and running distance recording. If some bracelets claim to be able to diagnose certain diseases or solve obesity, the side effects will lead to strict FDA regulation - they will no longer be classified as low-risk devices.
Wearables became one of the hot topics at the 2015 Las Vegas International Consumer Electronics Show. According to reports, most of the equipment unveiled at the show is in line with FDA's definition of low-risk equipment types, such as myBrain's Melomind, Healbe's GoBe, and navigation hardware manufacturer Garmin's VivoFit.
According to the media, according to the new FDA policy, future relatively simple wearing devices (including blood pressure measurement) will face a more relaxed regulatory environment, and they can be released to the market more quickly.
In addition, the FDA's guidance document only categorizes the health aspects of certain wearable devices. However, there is no clear definition of the statistical measurement accuracy of health equipment. TheVerge believes that this still leaves a regulatory gap on the measurement accuracy of products such as bracelets.
For example, many bracelets and smart watches on the market claim to be able to count calories burned or the number of walking and running steps, but their statistical accuracy is far from the level of medical equipment . Many users also find that different sports are used at the same time. The wristbands, the calorie consumption values ​​are not consistent. Because the FDA has not made regulations, these smart devices will not be required to achieve higher measurement accuracy in the future.
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