Medical Device Submissions Series: 510(k) & De Novo Workshop
Join industry leaders for the in-depth 510(k) & De Novo Workshop for real-world case studies, submissions tips and best practices.
Regulatory Affairs
Learn more about our Regulatory Affairs work.
AdvaMed Urges CMS to Protect Patient Access to Critical Medical Equipment
WASHINGTON — AdvaMed, the medtech association, the world’s largest trade association representing medtech innovators, today released the following statement on the U.S. Centers for Medicare & Medicaid Services’ (CMS) release…
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.
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. Three AdvaMed senior staff…
AdvaMed® Cybersecurity Summit
Join cyber experts for the Cybersecurity Summit that will address the latest industry issues and changes related to FDA requirements.
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,…