Medical Device Submissions Series: Investigational Device Exemption (IDE) Workshop
Our in-depth device submissions workshops will provide real-world case studies, tips and best practices directly from FDA and industry experts.
Regulatory Affairs
Learn more about our Regulatory Affairs work.
Medical Device Submissions Series: Premarket Approval (PMA) Workshop
Learn key PMA Submissions strategies to build a strong submissions, align with FDA expectations, and reduce delays.
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.
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. ThreeAdvaMed® senior staff members…