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Apple and Fitbit to be fast tracked by FDA to test new rules allowing them to track more health data

Apple and Fitbit fast tracked by FDA to test smart gadget rules  @IrmaRaste #iot #HealthTech

  • 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 U.S. 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 U.S. Food and Drug Administration said.
  • Apple, for example, has tended to partner with existing health researchers and companies DexCom Inc, a conventional medical device firm, for uses of their products that involve regulatory oversight.
  • 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 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.’

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 U.S. health regulator said on Tuesday.

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 U.S. 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 U.S. 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 Inc, a conventional medical device firm, for uses of their products that involve regulatory oversight.

But under President Donald Trump, the FDA has been moving to relax some of its requirements.

The FDA in July created…

Apple and Fitbit to be fast tracked by FDA to test new rules allowing them to track more health data