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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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