FDA initiates program towards streamlining approvals for digital devices

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Date: Monday, June 19th, 2017, 05:12
Category: Health, iOS, iPhone, Legal, News, Software, watchOS

This may help Apple’s plans to help make HealthKit ubiquitous and to get digital patient records out in a timely manner.

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 arrives as the FDA prepares to implement changes through its 21st Century Act agenda over the next few months. The agency offered the following comments as to the steps it’s looking to take:

…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 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.”

FDA representatives also added that the new pilot program will be the first step in a broader initiative that helps 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.

Stay tuned for additional details as they become available.

Via 9to5Mac

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