FDA Roundup: October 28, 2022

Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA updated the list of Breakthrough Devices that have been authorized for marketing. The list includes 56 Breakthrough Devices that the FDA has authorized for marketing. Online metrics show the number of granted Breakthrough Device designations by fiscal year and by clinical panel, which totals 728 as of September 30, 2022. The Breakthrough Devices Program provides patients and health care providers with timely access to medical devices by speeding up their development, assessment, and review, while preserving the statutory standards consistent with the FDA’s mission t...