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.
Simple Explanation
The FDA wants to hear what people think about special medical gadgets that help fewer than 8,000 people in the U.S. with rare health problems. They want to make sure these gadgets are safe and can be used more easily by asking people to share their thoughts by March 26, 2021.