Week 6: Critical Developments in MedTech Policy
The sixth week of updates brings significant developments in the MedTech industry, including new tariffs on Chinese medical technologies and draft FDA guidelines that could impact innovation. The United States Trade Representative (USTR) has proposed a 25% tariff on certain Chinese medical technologies, prompting AdvaMed to coordinate member feedback and prepare formal comments. Members are encouraged to submit details on the potential impact by June 10.
Key Updates:
- New Tariffs on Chinese MedTech: USTR’s proposed 25% tariff on certain Chinese medical technologies
- FDA Draft Guidelines: Two new draft guidances on non-device software functions and digital health technology
- CMS RFIs: AdvaMed is preparing comments on two CMS Requests for Information: one on National Coverage Determinations and another on Regulatory Relief
- White House EO: A new Executive Order on artificial intelligence and agency coordination
- MCIT Pathway Revision: CMS has issued a Request for Information on revising the Medicare Coverage of Innovative Technology pathway
AdvaMed continues to invite members to participate in the conversation to ensure MedTech perspectives are reflected in shaping policy. Members can view the full update and participate in providing feedback.
