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Rapid growth in the industry has led the U.S. Food and Drug Administration (FDA) to issue a draft guidance document outlining the types of health wearable devices it will and will not regulate.
Wearables have become increasingly popular in recent years, and demand doesn’t appear to be slowing down. The worldwide market for wearable technology products is expected to increase dramatically over the next several years, with some estimates exceeding more than $100 billion in annual sales by 2018.
This rapid growth has led the U.S. Food and Drug Administration (FDA) to issue a draft guidance document outlining the types of health wearable devices it will and will not regulate.
The FDA says that popular devices like fitness trackers, smart watches and mobile health apps fall outside of its purview because they are considered “low-risk general wellness products.” With the approach to nurture the development and innovation of wellness technologies the FDA looks to manufacturers to self-regulate and adopt voluntary requirements that help ensure user safety and data privacy in absence of FDA oversight. Products that claim to promote positive lifestyle habits, such as physical fitness, healthy eating and relaxation, will not be regulated, while devices that treat or diagnose chronic diseases or conditions — such as obesity, hypertension or anxiety — will continue to be regulated as medical devices.
While the FDA is currently finalizing its approach, the wearables industry can take steps now to deliver safe and secure health wearables into the marketplace. First, given the devices’ close proximity to the body, product safety testing for electrical shock, chemical and mechanical hazards is important. Also, wearables need to be tested for wireless interoperability to help ensure they do not interfere with other devices or lead to inaccurate data transmission from patient to provider. Finally, wearables need to be tested for privacy and security to evaluate any potential vulnerabilities that could compromise electronic health records.
UL continues to monitor the changing regulatory environment to help the wearables industry meet any and all requirements. UL helps manufacturers through the entire product life-cycle, beginning with the design process. Through the right balance of innovation and safety, wearables will continue to grow in popularity and maintain consumer confidence in their safe and secure performance.
For more information, please visit: https://industries.ul.com/blog/testing-solutions-for-wearable-technologies.