
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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Compliance
AdvaMed® has developed revisions to the AdvaMed® Code of Ethics to address evolving compliance and legal standards, account for innovative value-based care arrangements, and incorporate additional provisions on risk areas specific to medical technology companies.

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.
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