The Food and Drug Administration wants to unveil a new, more efficient risk-based regulatory approach to digital health technologies focused on fostering innovation and bringing these products to market more rapidly.
Writing in a June 15 blog, FDA Commissioner Scott Gottlieb, MD, outlined the agency’s forthcoming Digital Health Innovation Plan, the goal of which is to ensure the agency has the most modern and efficient regulatory approaches to evaluate new technologies that will ultimately benefit consumers.
“This plan will include a novel post-market approach to how we intend to regulate these digital medical devices,” wrote Gottlieb. “Greater certainty regarding what types of digital health technology is subject to regulation and regarding FDA’s compliance policies will not only help foster innovation, but also will help the agency to devote more resources to higher risk priorities.”
As part of a comprehensive approach to the regulation of digital health tools, Gottlieb said the FDA this fall will pilot “an entirely new approach toward regulating this technology (that) will be the cornerstone to a more efficient, risk-based regulatory framework for overseeing these medical technologies.”
While the pilot program is still being developed, the agency is “considering whether and how, under current authorities, we can create a third-party certification program under which lower risk digital health products could be marketed without FDA premarket review and higher risk products could be marketed with a streamlined FDA premarket review,” he wrote.
“Certification could be used to assess, for example, whether a company consistently and reliably engages in high-quality software design and testing (validation) and ongoing maintenance of its software products,” Gottlieb added. “Employing a unique pre-certification program for software as a medical device (SaMD) could reduce the time and cost of market entry for digital health technologies.”
Health IT Now, a coalition of patient groups, provider organizations, employers, and payers, responded favorably to the broad strokes of the plan outlined by Gottlieb.
“While we are awaiting more exact details on the full scope of the FDA’s plan, the vision outlined today by Commissioner Gottlieb is deeply encouraging and shows the Commissioner intends to make good on his goal of embracing new technologies. This is all about a modern FDA that better serves the needs of patients,” said Health IT Now Executive Director Joel White.
“Health IT Now has long believed that the regulatory process for new devices and therapies must take into consideration the rapid development cycles of health IT,” White added. “Through this Digital Health Innovation Plan, the FDA appears to be making a strong effort to do exactly that.”
Health IT Now urged the regulatory agency to “use real-world data in product development, expansion and postmarket surveillance, while working to ensure that requirements on data use are clear and not burdensome for product sponsors.”
Towards that end, Gottlieb’s blog stated that “post-market collection of real-world data might be able to be used to support new and evolving product functions.” For example, he said “product developers could leverage real-world data gathered through the National Evaluation System for health Technology (NEST) to expedite market entry and subsequent expansion of indications more efficiently,” adding that “NEST will be a federated virtual system for evidence generation composed of strategic alliances among data sources including registries, electronic health records, payer claims, and other sources.”
Bradley Merrill Thompson, general counsel for the Clinical Decision Support Coalition, which represents software developers, healthcare payers, providers and medical device manufacturers, praises the direction the agency is taking.
Thompson notes that Gottlieb expressly acknowledges the “ambiguity regarding how FDA will approach new technology can lead innovators to invest their time and resources in other ventures.” He also takes comfort in Gottlieb’s assertion that the agency should pursue “policies that are clear enough for developers to apply on their own, without having to seek out, on a case-by-case basis, FDA’s position on every individual technological change or iterative software development.”
“In the blog post, Commissioner Gottlieb also seems to reference the discussions that industry has been having lately with FDA regarding adoption of the TSA pre-check idea as a better way of bringing new software to market,” adds Thompson. “The blog post suggests that the agency is committed to this approach, which obviously we are delighted to hear. There is much good that can be done, although there is much work left to be done. It will be very important to get the details right.”
At the same time, he observes that Gottlieb seems committed to going beyond just the technology addressed in the 21st Century Cures Act. “Legislation always covers at best a few of the larger categories, and there is truly much more work to be done,” says Thompson. “FDA seems to be committing to publishing guidance in the coming months to clarify, beyond the legislation, what FDA will regulate in the area of clinical decision support and other such software. That is music to my ears. Indeed, throughout the post, it seems like we’re singing off of the same page.”
The 21st Century Cures Act provides much-needed clarification regarding the regulation of medical software. In particular, the law identifies five specific categories of medical software that—given certain conditions—will not be regulated as a medical device by the FDA based on their low level of risk to patients.
“FDA will provide guidance to clarify our position on products that contain multiple software functions, where some fall outside the scope of FDA regulation, but others do not,” wrote Gottlieb in his blog. “In addition, FDA will provide new guidance on other technologies that, although not addressed in the 21st Century Cures Act, present low enough risks that FDA does not intend to subject them to certain pre-market regulatory requirements.”
“We are excited about the FDA’s Digital Health Innovation Plan because it holds great potential to ensure that the health IT policies of today are suited to accommodate the innovations of tomorrow,” concluded White.
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