Seems like my Daily Device Bulletin is filled with software or apps obtaining marketing clearance from FDA. Today, it was a noninvasive hypotension prediction software finger-cuff device. But most of what the IRB receives is products designed for general wellness, compliance, coaching or reference. Apps using artificial intelligence, machine learning, active patient monitoring, and a variety of attachments may impact whether or not software or apps are considered to be FDA-regulated devices.
The following tool was developed to help determine when an app or software rises to the level of being an FDA-regulated medical device. Using the tool helps tease out the few designed to treat, cure, mitigate, prevent, or diagnose medical conditions, for which FDA has focused regulatory oversight.
Each category includes a decision tree and links to the source guidance. If still unsure, email inquiries may be sent to FDA at digitalhealth@fda.hhs.gov. The tool will likely evolve to keep up with the rapidly advancing tech world, so if you have feedback or questions regarding it's use, please email belinda.smith@uky.edu.
