AdvaMed, the Medtech Association, welcomed next steps in the Medical Device User Fee Amendments reauthorization process following clearance by the White House Office of Management and Budget of the draft MDUFA VI agreement.
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By Michelle Tarver MD PhD – For five decades, the 1976 Amendments have served as the foundation of a regulatory framework designed to protect patients while advancing innovation. It has ultimately helped to ensure that medical devices are safe, effective, and high-quality for the people who rely on them.
Starts August 26th in Boston MA – MEDevice Boston, by Informa, brings together leading medical device OEMs, startups, and suppliers from New England and beyond into a MedTech event engineered to advance the industry.
By Daniel Caños PhD MPH & Michelle Tarver MD PhD – Today’s health care ecosystem is generating richer and more diverse data streams, providing new opportunities to modernize how Real-World Data generates relevant and reliable Real-World Evidence. The FDA is working to provide clearer recommendations and more consistent acceptance of RWE as valid scientific evidence.
By Ellie Gabel – Automation is changing how the health care industry makes medical devices. Machines and smart software are helping factories work faster with fewer mistakes and steadier quality. Intelligent systems are creating greater improvements in the manufacturing process, and demand for them is growing quickly.
By Zac Amos – Cyberattacks on medical devices pose uniquely dangerous threats, facilitating data loss, enabling malfunction and risking lives. However, a software bill of materials is an important requirement that reduces these issues.
The U.S. Food and Drug Administration is announcing a public meeting to discuss proposed recommendations for the reauthorization of the Medical Device User Fee Amendments (MDUFA) for fiscal years 2028 through 2032. The current legislative authority for MDUFA expires on Sept. 30, 2027.
By Ellie Gabel – The rapid digitization of healthcare has ushered in a new era of connectivity and efficiency, led by the rise of the Internet of Medical Things (IoMT). This vast network of connected medical devices — from infusion pumps and patient monitors to smart imaging systems — forms the digital backbone of modern hospitals and laboratories.
By Zac Amos – While zero trust can benefit health care information technology professionals, several things should be considered before implementation. Neglecting these common challenges could cause trouble later.