QMSR Transition: Legal and Audit Perspectives
Join Hogan Lovells experts to learn how the FDA is set to reshape the medical device regulatory landscape with the introduction of the QMSR.
Regulatory Affairs
Learn more about our Regulatory Affairs work.
AdvaMed® Releases Technical Performance and Safety Bulletin on “Remote Device Operations: Common Challenges and Mitigation Strategies”
WASHINGTON, D.C. – AdvaMed, the MedTech Association®, recently published a technical performance and safety bulletin titled, “Remote Device Operations: Common Challenges and Mitigation Strategies” to help health care providers, device…
CDRH Director Tarver, Fellow FDA Leaders to Speak, Take Questions at The MedTech Conference
WASHINGTON, D.C.—AdvaMed, the MedTech Association®, today announced a town hall featuring FDA Center for Devices and Radiological Health (CDRH) Director Michelle Tarver and fellow CDRH senior leaders at The MedTech…
AdvaMed® in Action: Legal, Compliance, and Regulatory in the Spotlight at The MedTech Conference 2025
Christopher L. White, Esq., AdvaMed’s General Counsel & Chief Policy Officer, on why this year’s legal, compliance & regulatory programming is mission-critical as medtech leaders navigate uncertainty, shifting enforcement priorities,…
AdvaMed®, Patient Groups, State Medtech Associations Urge Medicare Coverage of Breakthrough Medtech
WASHINGTON, D.C.—AdvaMed, the MedTech Association®, is among 67 stakeholder groups, including patient advocacy groups and state medtech and life sciences associations, urging the Centers for Medicare and Medicaid Services (CMS)…
AdvaMed® Welcomes MDUFA VI Discussion Kickoff at FDA Public Meeting
WASHINGTON, D.C.—AdvaMed, the MedTech Association®, today welcomed the kickoff of the latest Medical Device User Fee Amendments (MDUFA) discussion at a public meeting at FDA headquarters. ThreeAdvaMed® senior staff members…
Medtech is Essential: Industry Supports Call for Tariff Flexibility
AdvaMed® President and CEO Scott Whitaker testified before the U.S. Senate Finance Committee, bringing attention to the pressing issue of how tariffs could impact the medtech industry and, most importantly,…
Orthogonal, Kwame Ulmer on the Value ofAdvaMed® Membership
AtAdvaMed®, we’re proud to be recognized for our work on behalf of the medtech community – and we’re especially grateful when that recognition comes from respected voices like Kwame Ulmer…
AdvaMed® Releases “AI Policy Roadmap” to Guide Congress and Federal Agencies
Washington, D.C.—AdvaMed, the MedTech Association®, today released its “AI Policy Roadmap,” a detailed policy outline for Congress and the federal agencies with jurisdiction over medtech to consider in promoting the…
AdvaMed® Congratulates Dr. Oz on his Confirmation as CMS Administrator
Washington, D.C.– AdvaMed, The Medtech Association®, today released the following statement from President and CEO Scott Whitaker on the U.S. Senate’s confirmation of Dr. Mehmet Oz to serve as Administrator of…