Bolstered by a new commissioner and provisions of the 21st Century Cures Act, the Food and Drug Administration is redefining how regulates digital health products.
The FDA is preparing to launch a Digital Health Innovation Plan that will “include a novel, post-market approach” to digital devices, Commissioner Scott Gottlieb, M.D., wrote in a blog post on Thursday. As part of that approach, the agency also plans to release new guidance for digital health products design to provide more clarity for manufacturers.
Our new Digital Health Innovation Plan: a more efficient, risk-based framework for overseeing these technologies https://t.co/NPpZR1iNUF— Scott Gottlieb, M.D. (@SGottliebFDA) June 15, 2017
Gottlieb argued that the new approach, designed to eliminate regulatory ambiguity, will drive innovation and free up regulators to focus on more pressing concerns.
“In this rapidly changing environment, ambiguity regarding how FDA will approach a new technology can lead innovators to invest their time and resources in other ventures,” Gottlieb wrote.
Digital health experts were ecstatic over the news, particularly as the industry has been pushing for more clarity from the FDA. The 21st Century Cures Act broadly addressed regulating new technology, but there was still some ambiguity about how the agency would oversee clinical decision support software. That issue has been a sticking point for organizations like the Clinical Decision Support Coalition, which released draft voluntary guidelines last month to ensure CDS software remains as a support tool.
“All in all, I feel like I’ve died and gone to heaven,” Bradley Merrill Thompson, a medical device attorney with Epstein Becker Green and the Coalition’s general counsel, wrote in an email to FierceHealthcare.
In a statement, Health IT Now Executive Director Joel White said he is “deeply encouraged” by the Gottlieb’s vision, adding that regulations need to keep pace the “rapid development cycles of health IT.
“This is all about a modern FDA that better serves the needs of patients,” he said.
Gottlieb also hinted at a regulatory approach to digital devices that mirrors the TSA's precheck program—an idea recently championed by the FDA’s associate director for digital health Bakul Patel. Gottlieb described a “third party certification program” where lower risk devices could be marketed without FDA approval, while higher risk devices could be streamlined based on the company’s history.
“In advocating for the precheck idea, we have advanced the notion that software creates certain unique opportunities to collect data on an almost real-time basis from the marketplace, and make continuous improvement through changes to the software,” Thompson said. “We’ve argued that that strength of the software development model could be used as a basis for creating the expedited pathway to market. It would seem as though FDA is interested in pursuing that line of thought.”
Meanwhile, the new Medical Device User Fee Agreement is still making its way through Congress. The agreement includes a central digital health unit within the FDA’s Center for Radiological Health, and Patel has said he is already hiring more than a dozen engineers from the private sector to fill key roles.