Successful Market Access of SaMD & MDSW: Decoding the Confusion in MedTech Software Development

Our in-depth device submissions workshops will provide real-world case studies, tips and best practices directly from FDA and industry experts.

Learn key PMA Submissions strategies to build a strong submissions, align with FDA expectations, and reduce delays.

Join industry leaders for the in-depth 510(k) & De Novo Workshop for real-world case studies, submissions tips and best practices.

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 of its 2026 Home Health Prospective Payment System final rule:

Join Hogan Lovells experts to learn how the FDA is set to reshape the medical device regulatory landscape with the introduction of the QMSR.

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 manufacturers, and IT teams navigate the complex landscape of remotely managing medical devices.

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 Conference hosted by AdvaMed in San Diego in October. The town hall participants will update the audience on the center’s strategic direction and priorities and take questions.

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, and a rapidly changing global legal landscape.