Recent Digital Health-Related FDA Announcements

The U.S. Food and Drug Administration (FDA) is showing its dedication to the advancement of digital health technology with two recent announcements:  a new Digital Health Center of Excellence and an update on its Software Precertification Program.  Manufacturers developing mobile medical devices, software as a medical device (SaMD), artificial intelligence (AI), and wearables when used as a medical device may want to become involved with new center and/or keep the components of the Software Precertification Program in mind.

Digital Health Center of Excellence

The FDA recently created the Digital Health Center of Excellence, a group of digital health experts assigned with providing technical advice to help accelerate access to safe and effective digital tools.  The new center aims to connect and build partnerships among stakeholders by accelerating digital health advancements, sharing knowledge, and innovating regulatory approaches.  The center is currently in Phase 1, where the focus is on raising awareness and engaging stakeholders.  Phase 2, set to begin at the end of the year, will focus on building partnerships.

Update on Software Precertification Program

The FDA also released an update on its Software Precertification (“Pre-Cert”) Program.  The goal of the Pre-Cert pilot is to develop a streamlined premarket review process for SaMDs, reducing unnecessary regulatory burden for both the medical device manufacturers and the FDA.  SaMDs range from apps on smartphones to computer-aided detection software.  With the Pre-Cert Program, the FDA first examines the medical software manufacturer rather than the medical device.  The companies that meet the criteria through the Pre-Cert process can seek a streamlined review of SaMD products.

Essential Components in the Software Pre-Cert Program

The Pre-Cert pilot project implements the Total Product Lifecycle Approach (TPLC), which the update outlined.  Four essential components are designed to reflect the total lifecycle of a product: 

(1) Excellence Appraisal – The FDA uses five main criteria (patient safety, project quality, clinical responsibility, cybersecurity responsibility, and proactive culture) to determine whether the medical software manufacturer demonstrates a robust culture of quality and organizational excellence.

(2) Review Determination – The medical software manufacturer itself would be allowed to determine the regulatory pathway for its own products.  Low-risk software products could be placed on the market with a simplified notification procedure.

(3) Streamlined Review – The FDA will develop a special approach to determine the scope of information to be provided by the medical software manufacturer when filing the initial submission.

(4) Real-World Approach – The medical software manufacturer shall collect and analyze information related to the actual performance of the software placed on the market to determine safety concerns and risks.

Although the development of the Software Pre-Cert Program involves nine (out of over 100) selected companies, it is still early in its development stage.  Additionally, the FDA may face major regulatory hurdles as it will need to ask Congress for the legislative authority to proceed. 

We will continue to monitor the efficacy of the Digital Health Center of Excellence and the trajectory of the Pre-Cert Program and update this post with any new developments.