Regulatory Affairs
Learn more about our Regulatory Affairs work.
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…
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.
Easing Disparities for Patients via Smart Technology, Equally Smart Policies
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.
AdvaMed® Urges CMS to Issue Proposed TCET Rule This Year, Offers Direction on Achieving Success for Medicare Beneficiaries to Receive Latest Medical Technologies
The Advanced Medical Technology Association® (AdvaMed®), the world’s largest trade association representing medical device manufacturers, urged the U.S. Centers for Medicare & Medicaid Services (CMS) to issue its proposed Transitional…
Renovia Receives FDA Clearance for leva® Pelvic Health System as First-line Treatment for Chronic Fecal Incontinence
Renovia Inc., an AdvaMed® member and developer of non-surgical, treatments for female pelvic floor disorders, announced the U.S. Food and Drug Administration (FDA) has cleared its leva® Pelvic Health System…
Reducing Regulatory Burden and Streamlining FDA Review Through ASCA Pilot Program Utilization
Join NAMSA and the FDA as they present a webinar on the Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program, a first-of-its-kind conformity assessment program created by the U.S. FDA.