On Thursday, July 27th the US Food and Drug Administration released details on its plans for regulating digital health technologies. Additionally, FDA shared information about its upcoming pilot program to pre-certify software-based medical devices.

In accordance with FDA’s Digital Health Innovation Action Plan, FDA’s Center for Devices and Radiological Health (CDRH) plans to improve digital health technologies by developing guidance on the medical software provisions of the 21st Century Cures Act.

Pre-Certification Pilot

Scott Gottlieb explains that, “this new program embraces the principle that digital health technologies can have significant benefits to patients’ live and to our healthcare system by facilitating prevention, treatment and diagnosis.”1

In the past, FDA struggled to determine how to best regulate non-traditional medical tools under the traditional approach to medical product reviews. Consequently, the new method addresses the unique characteristics of digital health products.

Gottlieb further explained the new program: “The goal of our new approach is for FDA to, after reviewing systems for software design, validation and maintenance, determine whether the company meets the necessary quality standards and pre-certify the company. Pre-certified companies could submit less information to us than is currently required before marketing a new digital health tool.”1 For certain low-risk devices, Gottlieb imagines companies could forego a premarket submission altogether.

Figure 1. FDA’s Proposed Precertification Process2

Digital Health

Source: RAPS











FDA plans to select up to nine software firms of various sizes to participate in the voluntary program beginning on the 1st of September 2017. There will also a webinar hosted by the FDA on August 1st with more information about the pilot.


According to RAPS, FDA plans to issue draft guidance on 21st Century Cures Act provisions for mobile medical apps, medical device data systems, medical image storage and communications devices, low-risk general wellness products and laboratory workflow by the end of 2017.

Return to the Pearl Pathways blog for updates on FDA’s actions towards digital health.



1 https://blogs.fda.gov/fdavoice/index.php/2017/07/fda-announces-new-steps-to-empower-consumers-and-advance-digital-healthcare/

2 http://www.raps.org/Regulatory-Focus/News/2017/07/27/28133/FDA-Updates-on-Digital-Health-Plans-Software-Pre-Certification-Pilot/?utm_source=Email&utm_medium=Informz&utm_campaign=Informz%2DEmails