AdvaMed® Comment Letter to FDA: Exemptions from Premarket Notification Requirements for Class II Devices
AdvaMed’s® comments on FDA’s 510(k) exemption framework for Class II devices and its impact on innovation and patient access.
Regulatory Affairs
Learn more about our Regulatory Affairs work.
Pulse on MedTech: How the Industry is Reigniting Growth and Expanding Markets
Join Ernst & Young LLP in this session that explores key trends shaping the sector.
The UPC – Three Years In Cross-Border Medtech Patent Strategy in the New European Landscape
Join McDermott Will & Schulte Law in this session that will explore practical, cross-border patent litigation strategies for navigating the UPC system specifically for the medtech sector.
The State of the MedTech Customer Base
Join L.E.K. Consulting to explore hospital financial health, purchasing behavior, and strategic priorities, and what they mean for medtech growth, partnerships, and innovation.
Beyond the Silo: Why Fragmentation Is MedTech’s Biggest Threat
Discover how Salesforce is helping medtech organizations improve margins and scale with AI powered, connected enterprise platforms.
FDA For-Cause Inspections Targeting Medical Device Manufacturers: Navigating the Process, Mitigating Risks
Join Hogan Lovells in this webinar will examine FDA for-cause inspections as they relate to medical device manufacturers.
AdvaMed® Comment Letter to ASTP/ONC: Accelerating AI Adoption in Clinical Care
AdvaMed’s® Comment Letter to ASTP/ONC, outlines concrete policy reforms across FDA oversight, CMS payment pathways, and HIPAA data-sharing rules to accelerate patient access to AI-enabled medical technologies. As AI-enabled medical…
i-GENTIC AI Launches Context-Aware MedTech Agents to Strengthen FDA 510(k) Submission Consistency
PALO ALTO, Calif., Feb. 11, 2026 i-GENTIC AI today announced a new suite of context-aware, multilingual MedTech agents designed to help medical device manufacturers improve the quality and consistency of…
Why Practical FDA Submissions Training Makes the Difference
Explore AdvaMed’s Medical Device Submissions Workshop Series from practical submission strategies to live expert insights you can apply immediately.
AdvaMed® Announces Melissa Torres as New Executive Vice President of Technology and Regulatory Affairs
WASHINGTON—AdvaMed, the MedTech Association®, today announced Melissa Torres is the new Executive Vice President of Technology and Regulatory Affairs. Torres succeeds Janet Trunzo, who retired after 30 distinguished, productive years withAdvaMed®.