The U.S. Food and Drug Administration on Thursday announced a pilot program to look into new precertification procedures for companies that make software. The agency hopes the initiative wil help cut down on the time and money needed to enter the digital health market.
Up to nine companies will participate in the Software Precertification Pilot Program and give the agency advice and feedback on what kinds of precertification protocols could supplant the current requirements for some products.
"We need a regulatory framework that accomodates the distinctive nature of digital health technology, its clinical promise, the unique user interface and the industry's compressed commercial cycle of new product introductions," wrote FDA commissioner Dr. Scott Gottlieb in his announcement of the program.
When applied to software, current requirements may be unnecessarily time-consuming and may get in the way of products getting to patients, the FDA wrote in a notice.
"FDA's traditional approach to moderate and higher risk hardware-based medical devices is not well suited for the faster iterative design, development and type of validation used for software products," the agency said. Some regulation, for instance, might get in the way of getting updated software to market quickly.
If the pilot program is effective, that may no longer be a problem, the agency hopes, as it would come up with processes that allow software to change "in a timely fashion." That could include reducing administrative burden and documentation necessary for companies to market their technology, which could be achieved be using external software development standards, the FDA wrote. The agency may turn to third parties for precertification, which would allow the FDA to focus on assessing higher risk technologies.
In some cases, precertified companies might not even need to give the FDA premarket submissions, Gottlieb wrote.
The Precertification Pilot Program is part of the FDA Center for Devices and Radiological Health's Digital Health Innovation Action Plan, an initiative to help promote digital health technology by revising the agency's policies and tools. Much of the plan describes how the agency will respond to the 21st Century Cures Act, which changes which technologies are subject to the FDA's approval. Some clinical decision support software, for example, will no longer fall under the FDA's jurisdiction.
The action plan also calls on the FDA to finalize draft guidance from August 2016 that explains that some medical devices must be re-approved any time they change significantly—which is particularly burdensome for devices the kind of machine-learning algorithms that are defined by their ability to change. The FDA did not note whether the findings from the Pilot Program would affect that specific software policy.