First Drug Device Combination of Its Kind for Chronic Wound Care Sarasota, FL, September 2, 2021 — Omeza, a skin science company, announced today the U.S. Food and Drug Administration (FDA) cleared Omeza® Collagen Matrix through the FDA 510(k) premarket notification process. Omeza® Collagen Matrix is Omeza’s first Rx product, and the first drug/device combination…
Today, the U.S. Food and Drug Administration announced participation in several new collaborative communities aimed at addressing challenges in patient health care. Collaborative communities are a continuing forum where private and public sector representatives of the community work together on medical device challenges to achieve common objectives and outcomes.
“We’re pleased to announce the progress we’ve made with participation in collaborative communities. These collaborations with diverse stakeholders are not only a strategic priority for the FDA’s Center for Devices and Radiological Health, they also provide much needed forums for deep discussion and solution-driven initiatives to tackle important issues within the medical device ecosystem,” said Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. “The insights and outcomes developed by these groups will have long-standing impacts on public health.” … read more