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# New FDA Digital Health Steps
- URL: https://www.fdaweb.com/new-fda-digital-health-steps/
- Published: 2017-07-27T12:00:00.000Z
- Updated: 2026-09-14T22:36:42.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5139234

FDA commissioner **Scott Gottlieb** says the agency is launching a Pre-Cert for Software pilot program that embraces the principle that digital health technologies can have significant benefits to patients’ lives and to the healthcare system by facilitating prevention, treatment, and diagnosis, and by helping consumers manage chronic conditions outside of traditional healthcare settings. Writing in an *FDA Voice* blog [post](https://blogs.fda.gov/fdavoice/index.php/2017/07/fda-announces-new-steps-to-empower-consumers-and-advance-digital-healthcare/?source=govdelivery&utm%5Fmedium=email&utm%5Fsource=govdelivery), Gottlieb says CDRH also is publishing a [Digital Health Innovation Action Plan](https://www.fda.gov/MedicalDevices/DigitalHealth/UCM567265?ref=fdaweb.com) with details and timelines for an integrated approach to digital health technology and implementation of the 21st Century Cures Act. “We’re telling consumers and the digital health industry how we will establish clear and consistent expectations for the products FDA regulates,” he says.

Gottlieb writes that the challenge FDA faces is how best to regulate such non-traditional medical tools with the traditional approach to medical product review. He says the agency envisions using the pre-cert pilot program to develop a new and pragmatic approach to digital health technology. “Our method must recognize the unique characteristics of digital health products and the marketplace for these tools,” he says, “so we can continue to promote innovation of high-quality, safe, and effective digital health devices.”

He says that the agency’s traditional approach to medical devices is not well suited to digital products and there is a need to ensure that the approach to innovative products with continual updates and upgrades is efficient and fosters, rather than impedes, innovation. “We must work toward establishing an appropriate approach that’s closely tailored to this new category of products,” he writes. “We need a regulatory framework that accommodates the distinctive nature of digital health technology, its clinical promise, the unique user interface, and industry’s compressed commercial cycle of new product introductions.”

The pilot was designed to work with up to nine software firms ranging from small startups to large companies, Gottlieb says. The intent is that after reviewing systems for software design, validation, and maintenance, FDA would determine whether a company meets the necessary quality standards and pre-certify it. Pre-certified companies could submit less information to the agency than is currently required before marketing a new digital health tool. In some cases, he says, pre-certified companies could bypass submitting a premarket submission and instead launch a new product and immediately begin post-market data collection.