The Food and Drug Administration (FDA) has announced a new program called the Safer Technologies Program for Medical Devices. This voluntary initiative is designed for certain medical devices and combination products that are expected to significantly enhance safety over existing options, but are associated with less severe conditions than those in the Breakthrough Devices Program. Eligible devices include those requiring premarket approval or clearance and aim to give patients quicker access to safer medical technologies. The program is modeled after the Breakthrough Devices Program, focusing on faster development and review processes without compromising existing regulatory standards.
Simple Explanation
The FDA has made a new plan to help make medical gadgets safer and get them to people faster, especially for problems that aren't very serious. This means devices can get a quicker check-up to make sure they are safe to use.