Regulatory Affairs
AdvaMed Outlines Four Key Priorities in Letter to President on Sterilization
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).
Regulations and Reimbursement of Software as a Medical Device in Europe- Part1
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…
AdvaMed’s Top 10 MedTech Wins in 2022
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…
MedTech POV Podcast: Titan Medical’s Cary Vance Talks Robotic Innovation in MedTech, the Importance of MDUFA V, and Addressing Supply Chain Issues
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…
Is Ethylene Oxide the Cheapest Medical Device Sterilization Method?
A false emerging narrative suggests ethylene oxide (EtO) sterilization is cheaper, easier, and faster than alternatives and thus preferred. Get the facts on the cost of EtO.
Op-ed: New Law Will Help FDA, Medical Technology Industry to Better Serve Patients
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.
MDUFA V Enacted, Ushering in Next Era of Medtech for Patients
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.
