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# New FDA Innovation Initiative Coming: Gottlieb
- URL: https://www.fdaweb.com/new-fda-innovation-initiative-coming-gottlieb/
- Published: 2017-06-15T12:00:00.000Z
- Updated: 2026-09-14T22:29:45.000Z
- Author: David McFarland
- Tags: Drugs, Devices, #legacy-id-D5138941

FDA commissioner **Scott Gottlieb** says it is incumbent upon the agency to have policies in place to promote safe and effective innovation to benefit consumers and to adopt regulatory approaches to enable efficient development of the technologies. To that end, he writes in an *FDA Voice* blog [post](https://blogs.fda.gov/fdavoice/index.php/2017/06/fostering-medical-innovation-a-plan-for-digital-health-devices/?ref=fdaweb.com), FDA will soon announce “a broad initiative that is focused on fostering new innovation across our medical product Centers.”

One aspect of the initiative, he writes, will be a Digital Health Innovation Plan that focuses on fostering innovation at the intersection of medicine and digital health technology. He says the plan will include a novel, post-market approach to how the agency intends to regulate digital medical devices.

Gottlieb outlines the ways in which digital technologies such as mobile apps, fitness trackers, and clinical decision support software have the power to transform health in important ways. For such technologies to reach their full potential, he writes, 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.”

Congress took a major step toward these changes in the 21st Century Cures Act, he says, by making clear that certain digital health technologies, such as clinical administrative support software and mobile apps intended only for maintaining or encouraging a healthy lifestyle, are generally outside the scope of FDA regulation. “FDA, led by CDRH, is working to implement the digital health provisions of the 21st Century Cures Act and, in the coming months, will be publishing guidance to further clarify what falls outside the scope of FDA regulation and to explain how the new statutory provisions affect preexisting FDA policies,” he says.

The commissioner says the agency will provide guidance clarifying its position on products containing multiple software functions, when some functions are outside the scope of FDA regulation and others are not. And he says there will be guidance on other technologies that were not addressed in the new law but still present low enough risks that FDA does not intend to subject them to certain pre-market regulatory requirements.

Another initiative announced by Gottlieb in the post is a pilot project for an “entirely new approach” to regulating digital health tools, expected to be the “cornerstone to a more efficient, risk-based regulatory framework for overseeing these medical technologies.”

“While the pilot program is still be developed,” he writes, “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 would reduce the time and cost of market entry for digital health technologies.”

Gottlieb also references a firm-based approach, rather than the traditional product-based approach that, combined with leveraging real-world experience, “would create market incentives for greater investment in and growth of the digital health technology industry. Such processes could enable developers to deploy new or updated software more rapidly and would help FDA to better focus our resources.”