The FDA is Taking an 'Almost Hands-Off Approach' to Regulating the Apple Watch

The FDA has announced that it's taking an 'almost hands-off approach' to regulating the Apple Watch and similar devices, reports Bloomberg.

Bakul Patel, who is responsible for oversight of new consumer focused health products at the Food and Drug Administration, said that devices such as the Apple Watch with health focused applications have a way to go before needing close scrutiny.

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


In February, the FDA released guidelines on regulating mobile apps. The fitness-tracking category was largely free from scrutiny but technology for diagnosis, treatment, and prevention will get a closer look. Much depends on how a product is promoted. If it's supposed to assist doctors in medical decisions then it will require more oversight.

"We are focusing only on the higher end of technology," Patel said. "What are benefits to public health against the risks to public health? We always try to balance that."

"We have to be confident in what we are getting," Patel said. "The trajectory is there 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."

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