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The FDA is accepting proposals to host in-person or remote visits to allow CDRH staff the opportunity to gain real-world knowledge through the CDRH Experiential Learning Program (ELP). Read More
Abbott announced that it is withdrawing all of its Trifecta heart valves from the U.S. market and removing the remaining inventory from the field due to early structural valve deterioration (SVD). Read More
Improving FDA advisory committee procedures and combatting misinformation are two important goals for FDA’s Chief Scientist Namandjé N. Bumpus who shared some insights from her first year of work during an informational “fireside chat” sponsored by the Alliance for a Stronger FDA on Wednesday. Read More
Upcoming events in the coming weeks include six FDA advisory committee meetings, the GMP Quality Management vSummit and webinars from FDAnews, a WCG company on reliability assessment and medical device risk management tools. Read More
Comments from numerous stakeholders have sounded the alarm over the lack of detail on oversight/responsibility for remote vendors and a new“task log” in the FDA’s draft guidance on decentralized trials (DCT). Read More
The number of Medical Device Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) applications and certificates in the European Union (EU) increased significantly in a recent six-month period, signaling some success in addressing the need for recertification to meet the EU’s new regulations. Read More
Risk management plans need to be continually updated as the design of a medical device or in vitro diagnostic evolves, said quality expert Dave Petrich in a July 19 webinar from FDAnews, a WCG company. Read More
Baxter Healthcare’s recall of 23,000 infusion pumps due to repeat upstream occlusion false alarms has been deemed class I by the FDA, the most serious type of recall as use of the device may cause injury or death. Read More
In the third revision to its guideline on good clinical practice, ICH E6, the International Council on Harmonisation (ICH) is proposing a full-scale restructuring of the document that has provided a global standard for sponsors, sites and investigators since 1996. In this blog post from Avoca, a WCG company, Karen Harvey, senior director of the Avoca Quality Consortium, outlines the changes in the new ICH draft guideline.Read More