FDA to Take "Almost Hands Off" Approach to Fitness Devices

When it comes to government regulation of wearable health devices, there might be grounds for cautious optimism:

Bakul Patel, who oversees the new wave of consumer-focused health products at the Food and Drug Administration, said most wearable gadgets such as the soon-to-be-released Apple Watch and health-focused applications for smartphones have a way to go before warranting close scrutiny from the agency.

“We are taking a very light touch, an almost hands-off approach,” Patel, the FDA’s associate director for digital health, said in an interview. “If you have technology that’s going to motivate a person to stay healthy, that’s not something we want to be engaged in.”


Two worries. The first is that as wearables become more functional, the FDA might decide, just one of those fashionable regulatory whims, that wearables no longer have “a way to go.” In that case, bend over for your “close scrutiny.”

The other worry is that the FDA might just decide that a truly functional wearable counts as a “medical device” and becomes subject to the onerous medical device tax.

We have got to start repealing laws and eliminating agencies while there’s still a chance for real innovations.


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