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FDA Won’t Scrutinize Low-Risk Wearables, mHealth Devices

By Jennifer Bresnick

Low-risk wearables, apps, and mHealth devices intended to support general wellness or healthy lifestyle choices will not be closely scrutinized by the Food and Drug Administration (FDA), the agency says in newly released draft guidance.  The guidance covers apps and devices that track user input, 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.

“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, the FDA 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.”

Separate draft guidance addressing the FDA’s scope of influence in relation to medical devices was also published in the Federal Register this week, defining what a “medical device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,” the document says. “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.”




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