A new initiative from the Food and Drug Administration could spur Apple Watch sales by making it easier to certify digital health devices, according to Yahoo! Finance.
Previously, under FDA regulation, Apple would have to get each Apple Watch certified, in a process that could require months. Having to go through FDA certification would also reveal the company’s products before release and could delay rolling out software updates. However, the FDA’s Digital Health Innovation Plan, and it could change everything.
Among other things, the move move could pave the way for the rumored Apple Watch for diabetics, “blowing open the market for Apple’s smartwatch from tech early adopters to hundreds of millions of people in need of blood glucose monitoring,” notes Yahoo! Finance. While the pilot program is still being developed, the FDA is “considering whether and how, under current authorities, we can create a third-party certification program under which lower risk digital health products could be marketed without FDA premarket review and higher risk products could be marketed with a streamlined FDA premarket review.
“For…digital technologies to take hold and reach their fullest potential, it is critical that FDA be forward-leaning in making sure that we have implemented the right policies and regulatory tools, and communicated them clearly, to encourage safe and effective innovation. In this rapidly changing environment, ambiguity regarding how FDA will approach a new technology can lead innovators to invest their time and resources in other ventures.” says FDA Commission Scott Gottlieb.
