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
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…
14th Annual FDA/AdvaMed Medical Device Statistical Issues Conference
This annual conference brings together leading authorities from FDA, industry and academia to address the latest statistical trends and issues facing medtech organizations.
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…