Did you catch our most recent edition of Fast Break? If not, we had an awesome extended session with Michele Buenafe on May 16 that was also part of our annual Technology May-rathon series. Michele described how the FDA is treating various types of software and hardware that may have healthcare functions as well as certain clinical decision support systems. Michele discussed some of the new and innovative ways that the FDA is trying to regulate—perhaps with a lighter hand—various AI and software systems that have historically had challenges with FDA oversight.

If you are actively developing a device that may have healthcare diagnostics capabilities, this topic is really important to you. FDA is in the midst of evolving how it perceives and regulates machine learning, AI, and other software programs, including those that may be subject to frequent updates that would have otherwise required almost daily notifications to the FDA. In light of FDA’s new regulatory regime, software providers need to understand what is required of them during development of their technologies. If you have any questions regarding your technology, reach out to Michele Buenafe.