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FDA takes hands-off approach to wellness devices

If you have a pacemaker in your chest, the FDA wants to make sure the device works correctly. But if you want to wear a Fitbit, the agency will leave you alone.

In another sign that the FDA intends to assume a markedly hands-off policy when it comes to the wellness devices and programs that are proliferating in the health IT marketplace, the federal regulatory agency’s Center for Devices and Radiological Health (CDRH) has issued

The CDRH considers wellness devices to be products only intended for general health and available from retailers.

In particular, the products in this category involve claims about sustaining or improving a general state of health and refer to specific diseases or conditions.

Areas monitored by these devices include weight management, physical fitness, stress management, sleep management and sexual function.

Many products on the market – ranging from Fitbit and Jawbone UP wellness bands to smart watches from Pebble, Withings, Samsung, Microsoft, the upcoming Apple Watch and others – offer such capabilities to log, track and trend exercise activity.

As the wellness movement gained momentum last year, the FDA first indicated it was tending toward deregulation when the agency down-classified from Class III high-risk to Class I low-risk what it calls mobile device data systems – which include smartphone app-tethered wellness devices.

In doing so, however, the FDA also sparked criticism from some safety advocates worried that when wellness systems start to move into true medical settings, some of these devices could be under regulated.

Also last year, the FDA issued similar guidance on medical image storage and communications devices, saying they largely pose little safety threat to patients.

With its most recent move, on Jan. 20, the agency also noted a second category of general wellness systems that, using tracking or motivational tools as part of a healthy lifestyle, may help reduce the risk of — or promote “living well” with — certain chronic diseases or conditions.

With this group of products, the FDA cautioned “general wellness claims should only contain references where it is well understood that healthy lifestyle choices may reduce the risk or impact of a chronic disease or medical condition.”