medical device classification

The FDA has expanded its list of medical devices exempt from premarket notification, easing the regulatory path for manufacturers across several product categories. The updated guidance touches everything from hearing protectors to diagnostic test strips — with real implications for how quickly new devices can reach market.

After years of regulatory complexity, the EU Commission offers medical device manufacturers a path forward: proposed changes limit AI Act requirements for devices, streamline risk classifications, and create efficiencies that could reduce costs and speed innovation.