Smartwatches, fitness trackers may escape FDA regulations

Smartwatches are among the devices that appear to have escaped the regulatory glare of the Food and Drug Administration (FDA).

The FDA this week proposed new guidelines for general wellness products like exercise equipment and other low-risk devices that promote a healthy lifestyle.


The FDA's draft guidance would loosen the oversight of general wellness products used for weight management, physical fitness, relaxation, mental acuity, self-esteem, sleep management, and sexual function, the agency said.

"General wellness products can include exercise equipment, audio recordings, mobile apps, video games, and other products that are typically available from retail establishments," the agency wrote.

This would seem to apply to smartwatches like the Apple Watch and fitness trackers like Fitbits, as some news reports have also pointed out.

The public has 90 days to comment.