Not So Fast: Is That Software Really Still A Medical Device?

The U.S. passed the 21st Century Cures Act in 2016, which made many important changes to our regulation of healthcare products. One of these changes was in the definition of a medical device, specifically which types of software products are regulated medical devices. The FDA later released guidance for products such as MDDS, Clinical Decision Support Software, Mobile Medical Apps, and Multiple Function Device Products, clarifying which software is no longer under FDA’s oversight as a medical device. This guidance also identified software that is under “enforcement discretion”. Join industry expert, Michelle Jump, as she reviews the changes in the medical device definition and the FDA guidance that followed. Topics include:
Gain clarity around working in the area of new health software to determine if a product currently falls into the definition of a medical device
Strategies for keeping products in the lane of a non-medical device through careful design choices
Receive guidance on how to connect design and function with regulatory classification, so you know before you go to market