The U.S. Food and Drug Administration (FDA) has released a Digital Health Innovation Action Plan to share its vision for how it will soon regulate a variety of medical software.
A key part of the plan is a software precertification pilot program, an initiative that will help the FDA develop an efficient approach to regulating digital health technology, FDA Commissioner Dr. Scott Gottlieb wrote in a blog post.
"Our new, voluntary pilot program will enable us to develop a tailored approach toward this technology by looking first at the software developer or digital health technology developer, rather than primarily at the product (as we currently do for traditional medical products)," he wrote. "This pilot will help us establish the most appropriate criteria for standing up a firm-based precertification program for these new tools."
Companies may request permission to participate in the software precertification pilot program beginning August 1. During August, the FDA's digital health team will evaluate submissions and select nine companies for the program.
In addition, the Digital Health Innovation Action Plan signals the FDA's intention to provide new guidance on implementing the 2016 21st Century Cures Act, including policy on mobile medical applications; medical device data systems used for the electronic transfer, storage, display, or conversion of medical device data; medical image storage devices to store or retrieve medical images electronically; and medical image communication devices for transferring medical image data electronically between devices.
The FDA's goal is to issue draft guidance on these software areas by the end of 2017, the agency said. It will also release draft guidance by the end of this year on when to submit a 510(k) application for a software change to an existing device.
Finally, during the first quarter of 2018, the FDA plans to issue draft guidance on clinical decision-support software and its oversight of products with software functions that fall under the FDA's medical device oversight and those that do not.
