
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.
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AdvaMed’s® comments on FDA’s 510(k) exemption framework for Class II devices and its impact on innovation and patient access.

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 highlights major legislative and regulatory wins delivering millions in savings and new revenue for members.

Medicare breakthrough medical technologies face delays between FDA authorization and coverage decisions, slowing patient access to innovation.

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…
Brought to you by AdvaMed®, Medtech POV with Scott Whitaker is a podcast that covers the intersection of medtech and policy from every perspective.

Explore the 2026 State Policy Briefing Series for insights on medtech policy, legislative activity, and regulatory updates impacting the medtech industry.

AdvaMed® comment letter to the OIG’s recommends updates to safe harbors, value-based arrangements, & oversight to support value-driven healthcare.

As tariff uncertainty continues in 2025,AdvaMed® plays tariff chess, advocating for predictable, zero-for-zero policies to protect medtech innovation and access.

AdvaMed® Advancements: Q4 2025 Report highlights how unified industry advocacy responded to policy disruption, trade uncertainty, and federal action impacting medtech.