The agency hasn’t seen as much developmet of these tools yet, according to FDA Commissioner Scott Gottlieb, and he attributed that in part to “regulatory ambiguity.” Gottlieb intends the guidance to offer some clarity, including about which kinds of clinical decision support tools would not be classified as medical devices and therefore would not be subject to FDA regulation.
For example, software that gives providers treatment guidelines for common conditions, given a patient’s diagnosis, would not be considered a medical device and would not be regulated by the FDA.
“I am hopeful that we’re going to see more innovation in this space, including tools that can sit on top of the electronic health record,” said FDA commissioner Scott Gottlieb in a hearing Thursday on the implementation of the 21st Century Cures Act.
Along with guidance on clinical decision support, the FDA released two other guidance documents Thursday, both about software as a medical device. In a draft guidance, the FDA outlines which types of software it does not consider medical devices. These types of software, which include health-lifestyle apps, would not be regulated by the FDA. For example, an app that attempts to “soothe and relax” people with music would not be regulated by the agency.
In a final guidance, the FDA addresses the regulation of software that is considered a medical device, giving regulators approaches for evaluating the safety and efficacy of that software.
These guidance documents are good examples of the FDA’s overall approach: going beyond the provisions outlined by Congress in the 21st Century Cures Act, according to Gottlieb.
“Through this comprehensive approach, we can deliver on our commitment of promoting beneficial innovation in this space while providing proper oversight where it’s merited,” Gottlieb said in a statement.
These new guidances come on the heels of the final guidance the FDA released Monday about 3-D printed medical devices. In that document, the FDA outlined the path developers need to take to get their devices approved.
“This focus on innovation couldn’t come at a better time,” Gottlieb said in the hearing. “We stand at an inflection point in medicine.”