FDA exempts non-medical-grade wearable data devices from regulation

Marty Makary, the US Food and Drug Administration (FDA) Commissioner, said wearable devices, like Apple Watch and Whoop, which provide non-medical-grade information, will not be subject to FDA regulations.

However, these devices will not be able to make claims related to disease diagnosis or treatment.

FDA clarifies digital health approach

The FDA clarified its approach to digital health and artificial intelligence, and Dr Makary told Fox Business: “We want to let companies know, with very clear guidance, that if their device or software is simply providing information, they can do that without FDA regulation.

“The only stipulation is if they make claims of something being medical grade, like a clinically appropriate, clinical-grade blood pressure measurement. We don’t want people changing their medicines based on something that’s just a screening tool or an estimate of a physiologic parameter.

“If they’re not making claims that they are medical grade, let’s let the market decide. Let’s let doctors choose from a competitive marketplace which ones they recommend for their patients.

“Many of these AI medical devices and software-based technologies are improving over time. So, for us to use an old model at the FDA to simply put a rubber stamp on something isn’t really appropriate for an evolving marketplace.”

Makary also spoke on people using Google and ChatGPT to get their medical advise.

“If something is simply providing information, like ChatGPT or Google, we’re not going to outrun that lion. We’re not going to go in there and say, ‘There’s one result that is inaccurate, therefore we’ve got to shut this down’.

“We have to promote these products and, at the same time, just guard against major safety concerns.”

The guidance, along with comments from FDA Commissioner Marty Makary, adds to existing policy that classifies low-risk wellness tools, such as fitness apps and activity trackers that encourage exercise, as non-medical devices exempt from stringent regulation.

Shares of continuous glucose monitor manufacturers Abbott, Medtronic and Dexcom closed between 1 per cent and 4 per cent higher. US-listed shares of fitness smartwatch maker Garmin ended nearly 3 per cent higher.

Last year, the FDA issued a warning letter to fitness band maker Whoop, saying its blood-pressure insights feature blurred the line between wellness and medical devices by estimating systolic and diastolic values used to diagnose hypertension.