Government & Legislative Affairs / Regulatory Affairs

AdvaMed Welcomes Key Developments in MDUFA VI Process 

WASHINGTON, D.C.—AdvaMed, the Medtech Association, today welcomed next steps in the Medical Device User Fee Amendments reauthorization process following clearance by the White House Office of Management and Budget of…

Coverage & Payment / Diagnostics / Digital Health / Government & Legislative Affairs / Health Access / Regulatory Affairs

AdvaMed Statement on the Klomp Nomination

WASHINGTON—Scott Whitaker, president and CEO of AdvaMed, the largest trade association representing medtech innovators, posted his statement on LinkedIn regarding the nomination of Chris Klomp as deputy secretary of the…

Diagnostics / Regulatory Affairs

Clinical Evidence for IVD Medical Devices

AdvaMed’s feedback on the CEIVD draft outlines targeted recommendations to improve clarity in clinical evidence expectations for IVD devices, including more precise terminology, alignment with global frameworks, and clearer distinctions…