In April 2025, the U.S. Food and Drug Administration (FDA) unveiled their roadmap designed to reduce, refine, and potentially replace animal testing, beginning with monoclonal antibody therapies and expanding to other drug modalities. This marks an institutional shift toward modern, human-relevant evaluation methods and signals a new era in regulatory [...]

In June 2025, the U.S. Food and Drug Administration (FDA) issued a long-anticipated draft guidance that clarifies the process for transferring ownership of 510(k) clearances. The document: “Transfer of a Premarket Notification (510(k)) Clearance” addresses long-standing ambiguity around when and how a 510(k) can be transferred between organizations, particularly during [...]

On July 17, 2025, President Donald Trump issued an executive order granting 39 medical device sterilization facilities a two-year extension to comply with new ethylene oxide (EtO) emissions limits. This move follows months of industry pushback and growing concerns about potential disruptions to the medical device supply chain. […]

In a move aimed at strengthening patient safety and enhancing transparency, the FDA’s Center for Devices and Radiological Health (CDRH) has announced a new communications pilot program that seeks to reduce the time between the agency’s awareness of a high-risk medical device issue and its public notification. This initiative reflects [...]