Senators Question User Fee Hike In Committee Hearing
The proposed MDUFA V package would almost double device user-fee funding – but is it worth it? Sen. Richard Burr, R-NC, expressed some doubts at a Tuesday committee hearing.
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Impero senior vice president of products Sam Heiney spoke to Medtech Insight about reframing the way medtech and healthcare organizations think about cybersecurity regulations.
Digital Health: FDA’s Shuren Predicts ‘Critical Regulatory Hurdles’ If Congress Doesn’t Update Reg Frameworks
US FDA device center director Jeff Shuren is strongly urging lawmakers to come up with modern digital health regulatory frameworks and more strongly tackle cybersecurity issues.
Public policy group The Pew Charitable Trusts is concerned that the latest iteration of the Verifying Accurate, Leading-edge IVCT Development (VALID) Act prioritizes a faster time to market over patient safety. The group had previously signed onto a letter praising the proposed legislation, which aims to build a new regulatory framework for diagnostics in the US.