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Pilot program to modernize digital health software regulatory framework

Tuesday, October 10, 2017

The FDA has named nine companies selected to participate in a first-of-its-kind pilot program designed to revolutionize digital health regulation in the U.S.

The importance of this pilot program is vast and the driving force behind why the FDA is launching it. According to the FDA, “The FDA’s Pre-Cert Pilot Program is intended to inform a tailored approach to digital health technology by looking at the software developer or digital health technology developer, rather than primarily the product.”

Of the 165,000+ health-related apps that are currently available, some fall into the medical devices arena. Software as a Medical Device (SaMD) carries a specific, detailed definition adopted by regulators. The definition specifies attributes of apps that fall within this category. As a result, regulation of SaMD apps is a means of protecting patients and consumers, according to Anne Zielinski, vice president, Technology Alliances, Bioclinica. “Digital health software developers and providers should welcome regulatory oversight which gives organizations employing those apps in their clinical trials—as well as patients—a level of confidence and protection,” said Zielinski.

What this means for the industry is that the FDA’s Digital Health Innovation Action Plan embodies the agency’s vision for the regulation of digital health technologies that are medical devices, keeping with the FDA’s overall mission to protect the public’s health.

“We have been regulating digital health products for a long time. However, we recognize that our current method for regulating these products—reviewing each software product—is not well suited to software’s very rapid and iterative environment. We hope that by changing how we regulate this sector, we can help firms bring innovative products to market sooner,” said Stephanie Caccomo, press officer, FDA.

According to Eric Kolodziej, Ph.D, global head of Quality and Regulatory Affairs, Roche Diagnostics, “This action plan and the regulatory environment that will be created is both timely and necessary with the growing number of medical software products and digital health devices. The information provided, and the software that interprets it, must provide accurate and safe information as consumers and caregivers will use this information to make medical decisions.”

In this way, the FDA is offering a digital health regulation system framework that is keeping pace with the modernization and innovation already taking place within the industry.

As Dr. Scott Gottlieb, former FDA commissioner, said: “We need to modernize our regulatory framework so that it matches the kind of innovation we’re being asked to evaluate, and helps foster beneficial technology while ensuring that consumers have access to high-quality, safe and effective digital health devices. These pilot participants will help the agency shape a better and more agile approach toward digital health technology that focuses on the software developer rather than an individual product.”

“Timing is everything. The regulations around apps have lagged years behind innovation and consumer uptake,” said Zielinski. “And regulations are still playing catch-up with availability and use of apps, wearables and sensors to monitor and influence healthcare.”

With the launch of this new digital health software pre-certification pilot program, the FDA is outlining an aggressive approach to addressing both how quickly the digital health space changes, and the innovative needs of the digital health space to the industry. According to Kolodziej, “The FDA has recognized the need for fit-for-purpose systems in both the development and in the review of these novel devices, and is getting ahead of this. This can only be positive for the industry and ultimately consumers.”

With interest from over 100 companies, the FDA selected the following nine to be participants:

When the FDA chose these nine companies, they considered several factors, such as company size, demonstrated record of quality and organizational excellence, clinical focus area and the risk profile of the product.

The selected companies are uniquely positioned to work with the FDA to develop the regulatory framework for these types of products. Pre-Certification Program participants will become the FDA’s industry partners, learning together to ensure safe and effective products while trying to keep pace with this rapidly changing development environment.

Zielinski of Bioclinica commented on another benefit. She said, “For those companies that receive FDA pre-certification, it gives the green light to them and the sponsors seeking to employ their devices from those companies, ultimately helping accelerate the proliferation of digital health software in clinical trials. Companies that receive pre-certification will have a cleared regulatory path to refine existing SaMD products and to innovate and introduce new offerings without waiting for SaMD-specific regulatory approval.”

This Pre-Certification Program is an acknowledgement of the state of digital health app development, hosting, big data, software and digital technologies. By allowing regulators to define a framework under which valuable technologies can be provided to patients and caregivers, this program will help the FDA understand whether they can take a new approach to regulating digital health products or not.

According to Caccomo, “We [the FDA] are collaborating with the industry to determine the most appropriate key performance indicators. The benefits for consumers will be tremendous. This pre-cert program has the potential to bring innovative products to market much sooner. We think this is a game changer! It’s a very innovative way for the FDA to approach regulating a medical product.”


This article was reprinted from Volume 21, Issue 40, of CWWeekly, a leading clinical research industry newsletter providing expanded analysis on breaking news, study leads, trial results and more. Subscribe »

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