Next-gen health monitors to need US regulator approval

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Digital devices designed to monitor the wearer’s health in much greater detail than current models will need regulatory approval, and Apple, Fitbit, and seven other companies will take part in a program to speed the approval process, the US health regulator said on Tuesday.

The firms will take part in a program that could make it faster for digital health devices to come to market by requiring less information to be sent to regulators ahead of time, the US Food and Drug Administration said.

Current devices, like the Apple Watch or Fitbit Blaze, measure things like motion and heart rate. But to take further measurements like blood oxygen or glucose, future devices might full under regulatory review. That review can take months or years, which is far slower than the pace of software updates from most technology firms.

Because of the potential for lengthy reviews, consumer technology companies have been reluctant to wade directly into territory regulated by the FDA. Apple, for example, has tended to partner with existing health researchers and companies DexCom, a conventional medical device firm, for uses of their products that involve regulatory oversight.

Apple watch /Reuters Photo

But under President Donald Trump, the FDA has been moving to relax some of its requirements. The FDA in July created a pilot program that would pre-certify certain companies so that they have to submit less information before marketing a product.

The initial participants in the pilot program also included Samsung, Alphabet's Verily biotech unit, Johnson & Johnson and Swiss biotech firm Roche, among others.

The FDA said in a statement it was also considering whether companies in the pilot program “may not have to submit a product for premarket review in some cases.”

“Our method for regulating digital health products must recognize the unique and iterative characteristics of these products,” FDA Commissioner Scott Gottlieb said in the statement.

One major difference in the pilot program from existing regulations is that it will evaluate companies based on how well their software-design systems work, rather than looking at each product and its accompanying software individually.

“We are hopeful this will allow us to accelerate FDA regulated features and software development, bringing new capabilities that could positively impact health outcomes to market more quickly,” Fitbit CEO James Park said in a statement.

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Source(s): Reuters