Search Results for keywords:"Medical Devices"

The Food and Drug Administration (FDA) is collecting information regarding humanitarian use devices (HUDs), which are medical devices meant for conditions affecting fewer than 8,000 people in the U.S. The FDA seeks public comments on this information collection by March 26, 2021, to help decide whether these devices should be exempt from certain effectiveness requirements. This effort is in accordance with the Paperwork Reduction Act and aims to ensure that those with rare conditions have access to necessary medical devices without significant safety risks. Additionally, the FDA updated estimates of the time and resources needed for this data collection to reflect more current information.

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.