In early January, the Food and Drug Administration delivered on the Trump administration’s deregulatory promises by allowing more wellness products to be marketed without the agency’s authorization. Leaders at smart ring maker Oura swiftly planted the pivot foot.
“As soon as this guidance came out, literally the same day, we started having conversations with our product team around what our roadmap looks like, features that we could bring in and actually ship sooner,” Ricky Bloomfield, the company’s chief medical officer, told STAT less than a week after the FDA announcement. He added: “this guidance helps give us more confidence that we can release features sooner and not have to spend months getting additional clarification from the FDA.”
One thing FDA clarified in the updated guidance is that companies can release products that use sensors to “estimate, infer, or output” blood pressure and blood glucose readings without approval, if they are intended for wellness purposes. In a speech at the Consumer Electronics Show the day the guidance was announced, the FDA commissioner at the time, Marty Makary, said his agency would “get out of the way” of products that weren’t making medical or clinical claims. “This reduces the amount of subjectivity by regulators and guesswork by developers,” he said.
