A U.S. Food and Drug Administration representative has said that the agency will treat health wearable devices, such as the Apple Watch, with an “almost hands-off approach” as long as they stay away from medical diagnosis.
“We are taking a very light touch, an almost hands-off approach,” FDA associate director for digital health Bakul Patel told Bloomberg. “If you have technology that’s going to motivate a person to stay healthy, that’s not something we want to be engaged in.”
The FDA in January released for comment guidelines that stated it wouldn’t attempt to regulate wearable devices marketed under the “general wellness” umbrella.
Claims that the FDA will allow under the catch-all of “general wellness” are those related to weight management, physical fitness, relaxation or stress management, mental acuity, self-esteem, sleep management, or sexual function.
If a device makes claims about the treatment or diagnosis of diseases and conditions such as obesity, eating disorders, anxiety, autism, muscle atrophy, or erectile dysfunction, it can expect to face scrutiny from the agency.
Devices which track activity or biological information can make certain disease-related claims when it’s also understood that a healthy lifestyle will reduce the risk of contracting a disease or aid in managing of said disease.
The FDA will hire a new senior-level liaison to communicate with tech companies involved in health-related wearables, due to worries that the market generally outpaces government change.
“We have to be confident in what we are getting,” Patel said. “The trajectory is there [for diagnosis via biometric monitoring] and all signals are headed that way, but by the same token the research and science should get us that confidence. It boils down to will it work or not.”