As announced in June, the U.S. Food and Drug Administration (FDA) is moving forward on a broad initiative focused on fostering new innovation in digital health, and one major part of this initiative will be a Digital Health Innovation Action Plan outlining how devices will be regulated.
On Thursday, the agency released its Digital Health Innovation Action Plan, as well as unveiled a new precertification pilot program that would soften the regulatory requirements for digital health companies with a track record of developing and testing quality products.
The purpose of FDA’s Software Pre-Cert pilot is to leverage customer input to develop a program that can help reduce the time and cost of market entry for software developers that FDA determines reliably manufacture high-quality, safe and effective digital health devices while providing appropriate patient safeguards, the agency said. Applying such an approach could improve support for continued innovation, allow for more rapid availability of new and updated software, and better focus FDA resources on higher-risk developers and products.
The FDA designed the new digital health pilot program to include up to nine software firms of various sizes. Initial participants in the pilot program will range from small startups to large companies that develop both high- and low-risk software products that are devices, the agency said.
Beginning August 1, the FDA will start evaluating applications to fill the pilot program’s nine slots. Companies interested in participating in the pilot can submit a statement of interest to FDAPre-CertPilot@fda.hhs.gov.
The FDA will hold a public workshop in January 2018 to report on and review its initial findings. The Federal Register notice announcing the Software Pre-Cert Pilot Program with more details about participation and the FDA’s goals can be found here.
In a blog post about the pilot program, FDA Commissioner Scott Gottlieb, M.D., wrote that digital health product developers will be selected for the program based on the following:
- The company must be in the process of developing or planning to develop a software product that meets the definition of a medical device;
- The company must have an existing track record in developing, testing, and maintaining software products and demonstrating a culture of quality and organizational excellence measures that are tracked by Key Performance Indicators (KPI) or other similar measures;
And during participation of the pilot, companies must agree to:
- Provide access to measures for developing, testing and maintaining software products and demonstrating a culture of quality and organizational excellence measures by KPI;
- Collect real-world post-market data and provide it to FDA;
- Meet with FDA for real-time consultation;
- Be available for site visits from FDA officials; and,
- Provide information about the firm’s quality management system.
In the blog post, Gottlieb wrote that the FDA has been challenged with determining how to best regulate non-traditional medical tools with the traditional approach to medical product review. “We envision and seek to develop through the Pre-Cert for Software Pilot 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, so we can continue to promote innovation of high-quality, safe, and effective digital health devices,” Gottlieb wrote.
“FDA’s traditional approach to medical devices is not well suited to these products. We need to make sure our approach to innovative products with continual updates and upgrades is efficient and that it fosters, not impedes, innovation,” he wrote. “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.”
To this end, the FDA’s new, voluntary pilot program is a step toward developing a tailored approach by “looking first at the software developer or digital health technology developer, rather than primarily at the product,” Gottlieb wrote.
The FDA aims to develop a precertification program that could replace the need for a premarket submission for certain products and allow for decreased submission content and/or faster review of the marketing submission for other products. Under this approach, the FDA’s Center for Devices and Radiological Health (CDRH) could ‘pre-certify’ eligible digital health developers who demonstrate a culture of quality and organizational excellence based on objective criteria. Pre-certified developers could then qualify to be able to market their lower-risk devices without additional FDA review or with a more streamlined premarket review, the agency said.
“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,” Gottlieb wrote. “In some cases, pre-certified companies could not submit a premarket submission at all. In those cases, the pre-certified company could launch a new product and immediately begin post-market data collection. Pre-certified digital health companies could take advantage of this approach for certain lower-risk devices by demonstrating that the underlying software and internal processes are sufficiently reliable. The post-market data could help FDA assure that the new product remains safe and effective as well as supports new uses.”
At the same time that it announced the pilot, FDA’s Center for Devices and Radiological Health (CDRH) also published its Digital Health Innovation Action Plan to provide details and timelines for its integrated approach to digital health technology and the implementation of the 21st Century Cures Act.