Learn more about our Regulatory Affairs work.
AdvaMed, The Medtech Association®, today welcomed the U.S. Environmental Protection Agency (EPA) extension of 15 more days for public comment on two proposed updates to regulations governing the use of…
WASHINGTON, D.C. – Following a Congressional hearing on “Preparing for and Responding to Future Public Health Security Threats,” AdvaMed, The Medtech Association®, released a statement from President and CEO Scott Whitaker echoing the…
Each year in the U.S., ethylene oxide sterilizes 20 billion medical devices, which are critical to preventing serious, even life-threatening, infections.
In a letter to the White House, the Advanced Medical Technology Association® (AdvaMed®) outlined four key priorities in pending regulations for facilities sterilizing medical devices with ethylene oxide (EtO).
This publication series explores “Software as a Medical Device (SaMD),” its challenges and the ways regulatory bodies try to address them, as well as the expected development of regulations related…
From MDUFA V and the major investments in semiconductor chip manufacturing in the CHIPS Act, to addressing global supply chain issues and supporting our AdvaMed Accel® companies, 2022 was a…
Cary Vance, President and CEO of Titan Medical, joined AdvaMed®’s Scott Whitaker on the Medtech POV podcast to share his experience leading a small medical device company through the regulatory…
In a RealClearHealth op-ed, AdvaMed® president and CEO Scott Whitaker outlines how the recently enacted medical device user fee agreement will help the FDA and medical technology innovators.
Congress overwhelmingly approved the fifth Medical Device User Fee Amendment (MDUFA) agreement, helping to ensure new medical technology receives a more efficient FDA review to reach patients sooner if approved.
CEO and surgeon Dr. Lishan Aklog speaks about the tremendous value of medical technology, the sharp disparities patients face, and the importance of policymaking to ease those disparities.