MDUFA V Agreement Enables Bold Medtech Vision to Become Reality
Congress is considering the latest agreement between the FDA and the industry to help fund agency consideration of medical devices with user fees.
Regulatory Affairs
Learn more about our Regulatory Affairs work.
Cook Medical receives FDA Breakthrough Device Designation for Zenith® Thoraco+ Endovascular System
AdvaMed® member Cook Medical’s Zenith® Thoraco+ Endovascular System (Thoraco+) has received Breakthrough Device Designation from the US Food and Drug Administration (FDA).
AdvaMed® Welcomes Opportunity to Testify on Historic Medical Device User Fee Agreement
AdvaMed® welcomes the opportunity to testify before a key congressional committee on the fifth reauthorization of the Medical Device User Fee Amendments (MDUFA).
AdvaMed® Statement on the FDA’s Draft Commitment Letter on the Medical Device User Fee Amendments V Agreement
The Food and Drug Administration (FDA) has released its draft commitment letter on the fifth reauthorization of the Medical Device User Fee Amendments (MDUFA), reflecting an agreement between the agency and the…
AdvaMed® Statement on Confirmation of Dr. Califf to Lead FDA
Today, the Advanced Medical Technology Association® (AdvaMed®), the world’s largest trade organization representing medical technology manufacturers, released the following statements from President and CEO Scott Whitaker and Chairman of the…
Trendspotting 2022: On the Pulse of Life Sciences
Sidley’s Global Life Sciences group looks at 12 forces driving the life sciences legal and regulatory landscape in 2022, and provides practical tips on a range of topics for life…
B. Braun Receives FDA Approval of Daytona Beach Pharmaceutical Manufacturing Site
Hyalex Orthopaedics, a privately-held medical device company developing transformational cartilage biomimetic products, today announced the appointment of Carl Vause as its new chief executive officer and president.
Edwards Lifesciences’ Mike Mussallem Joins Medtech POV for a Discussion on the Evolving Industry
Chairman and CEO of Edwards Lifesciences, Mike Mussallem joins AdvaMed®’s Scott Whitaker to discuss the dedication of those in the industry and how policy reform can help speed up the…
AdvaMed® Submits Recommendations to Department of Commerce to Address Semiconductor Chip Shortage and Supply Chain Issues
Today, the Advanced Medical Technology Association® (AdvaMed®) submitted a response to the Department of Commerce’s request for comments on the risks in the semiconductor supply chain.
AdvaMed® Welcomes Cody Uhing as Director of Media Relations, Communications
The Advanced Medical Technology Association® (AdvaMed®) announced that Cody Uhing recently joined the association as director of media relations and communications.