China GMP and ISO 13485: A Side-by-Side Comparison
China GMP and ISO 13485: A Side-by-Side Comparison
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Clinical Evidence for IVD Medical Devices
AdvaMed’s feedback on the CEIVD draft outlines targeted recommendations to improve clarity in clinical evidence expectations for IVD devices, including more precise terminology, alignment with global frameworks, and clearer distinctions…
AdvaMed’s Comments on EPA Sterilization Emissions Standards
AdvaMed outlines recommendations to ensure EPA’s proposed ethylene oxide (EtO) emissions standards protect public health while maintaining access to life-saving medtech.
AdvaMed® Advancements: Q1 2026 Report
Explore AdvaMed®’s Q1 2026 report on medtech policy, regulatory trends, reimbursement, and advocacy driving innovation and patient access.
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.
Listen to AdvaMed®'s Podcast
Brought to you by AdvaMed®, Medtech POV with Scott Whitaker is a podcast that covers the intersection of medtech and policy from every perspective.
2025 Annual Report
Explore AdvaMed®’s key achievements and milestones in 2025 on behalf of our member companies and the patients they serve.
AdvaMed® 2025 Membership Has Its Privileges: Advocacy Wins for Medtech Members
AdvaMed® 2025 Membership Has Its Privileges highlights major legislative and regulatory wins delivering millions in savings and new revenue for members.
Scott Whitaker Op-Ed: Medicare must keep pace with FDA-authorized breakthrough medical technologies
Medicare breakthrough medical technologies face delays between FDA authorization and coverage decisions, slowing patient access to innovation.
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…