Quality Systems Archives - Quality Solutions Now (QSN)

FDA Issues Draft Guidance on 510(k) Transfer Protocols for Biotech and MedTech Firms
In June 2025, the U.S. Food and Drug Administration (FDA) issued a long-anticipated draft guidance that clarifies the process for transferring ownership of 510(k) clearances.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
The FDA’s CDRH has launched a pilot program to accelerate public communication of high-risk medical device recalls. Learn what this means for manufacturers and how to prepare your recall and risk management systems. […]