Quality Systems Archives - Quality Solutions Now (QSN)

FDA to Phase Out Animal Testing Requirements, Promising Accelerated Cures and Smarter Drug Development
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 [...]
FDA Issues Draft Guidance on 510(k) Transfer Protocols for Biotech and MedTech Firms
In June 2025, the U.S. Food and Drug Administration (FDA) issued a long-anticipated draft guidance that clarifies the process for transferring ownership of 510(k) clearances.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 [...]
Trump Grants Two-Year Delay for EtO Compliance: What It Means for Medical Device Manufacturers
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 [...]
FDA Launches Communications Pilot to Accelerate High-Risk Medical Device Recall Notifications
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 [...]