FDA developing pilot program to streamline approvals for digital health devices

Jun 18, 2017
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:

“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.”

Continue reading: https://9to5mac.com/2017/06/16/fda-food-drug-administration-apple-digital-health-medical-regulation-pilot/