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Week 6: Regulatory Shifts, Tariff Action & Industry Feedback

Screenshot of AdvaMed’s “Rapid Response Updates” email featuring a summary of fast-moving policy developments

New tariffs on Chinese medtech, key RFIs, and FDA draft guidances shape a busy policy week—your input is critical.

Week 6 brings urgent developments, including USTR’s proposed 25% tariff on certain Chinese medical technologies.AdvaMed® is coordinating member feedback and preparing formal comments. Members are encouraged to submit impact details by June 10. The update also includes two draft FDA guidances on non-device software functions and digital health tech that could significantly influence innovation. Additionally,AdvaMed® is preparing comments on two CMS RFIs: one on National Coverage Determinations and another on Regulatory Relief. Other highlights include a new White House EO on artificial intelligence and agency coordination, plus a CMS Request for Information on revising the Medicare Coverage of Innovative Technology (MCIT) pathway.AdvaMed® continues to invite members to participate in the conversation and ensure MedTech perspectives are reflected in shaping policy.

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