FDA To Monitor Some mHealth Wearables
By Christine Kern, contributing writer
An FDA regulation will cover wearables making health claims, but not ‘low-risk’ wearables.
The Food and Drug Administration (FDA) has released new draft guidance making clear its intention to closely scrutinize certain sectors of the mHealth wearable market. However, low-risk wearables, apps, and mHealth devices intended to support general wellness or healthy lifestyle choices will not be included in that scrutiny, according to the agency.
The guidance targets those apps and devices which track user input and make health claims about the wearable’s ability to provide encouragement, or help to manage chronic diseases, sleep, diet, or other physical and mental health attributes without intending to treat or otherwise influence a patient’s safety and care. The guidance will be open for a 90-day comment period.
“General wellness products can include exercise equipment, audio recordings, mobile apps, video games, and other products that are typically available from retail establishments (including online retailers and distributors that offer mobile apps to be directly downloaded),” when the items in question present an insignificant risk to a patient’s safety, FDA officials says.
“If the product is invasive, involves an intervention or technology that may pose a risk to a user’s safety if device controls are not applied (such as risks from lasers, radiation exposure, or implants), raises novel questions of usability, or raises questions of biocompatibility, then the device is not covered by this guidance.”
The Federal Register also published separate draft guidance addressing the FDA’s scope of influence in relation to medical devices, defining what a “medical device accessory” means and how it will fall under the FDA’s purview.
“FDA considers an ‘accessory’ as a medical device that is intended to support, supplement, and/or augment the performance of one or more medical devices,” according to the guidance document. “In practice, the distinctions among devices that support, supplement, and/or augment parent devices are subtle and many devices that we would consider to be an accessory may do more than one of these things.”
PC World points out this guidance is significant as, even though the vast majority of health and wellness trackers on the market today won’t require FDA oversight, there has been an explosion in the development of wearables across a diverse range of devices – some aimed at niche audiences. Some of these devices are even making the transition from basic monitoring and advice to actual treatment, which means scrutiny and federal regulation will become even more pertinent to protect consumer safety.