FDA developing pilot program to streamline approvals for digital health devices

The U.S. Food and Drug Administration (FDA) commissioner Scott Gottlieb this week released a statement on how the government agency is aiming to streamline innovation of digital health and medical technology through a new approach to regulating devices:


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FDA will soon be putting forward a broad initiative that is focused on fostering new innovation across our medical product centers. I will have more to say on many elements of this initiative soon. However, today I want to focus on one critical aspect of this innovation initiative: A new Digital Health Innovation Plan that is focused on fostering innovation at the intersection of medicine and digital health technology. This plan will include a novel, post-market approach to how we intend to regulate these digital medical devices.

The new plan comes as the FDA also prepares to implement the 21st Century Cures Act over the next few months and will include a pilot program being developed to serve as a third party certification process for digital health products:

…we are 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. Certification could be used to assess, for example, whether a company consistently and reliably engages in high quality software design and testing (validation) and ongoing maintenance of its software products. Employing a unique pre-certification program for software as a medical device (SaMD) could reduce the time and cost of market entry for digital health technologies.

The updates for the FDA’s process on approving medical devices is notable for Apple as Tim Cook has confirmed on several occasions that in many ways required approvals dictate the pace of health features that come to its devices like Apple Watch.

In an interview back in 2015, Cook noted that the FDA approval needed for full-on health devices would slow down the pace of innovation of the Watch. “We don’t want to put the watch through the Food and Drug Administration (FDA) process. I wouldn’t mind putting something adjacent to the watch through it, but not the watch, because it would hold us back from innovating too much, the cycles are too long.”

The new program being piloted by the FDA would hopefully ease the process for certain digital medical devices for both Apple and other developers, with the agency itself noting that the program should “enable developers to deploy new or updated software more rapidly and would help FDA to better focus our resources.”

Gottlieb adds that the new pilot program will be the first step in a broader initiative that aims to help the FDA offer “the most modern and efficient regulatory approaches when it comes to evaluating new, beneficial technologies.”

Apple has new health and medical features arriving with watchOS 4 and iOS 11 later this year, including new functionality for diabetes management, insulin delivery, CoreBluetooth support, and much more.


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