AdvaMed and other stakeholders have raised concerns with the FDA's digital health software precertification pilot working model, including a lack of harmonization between the International Medical Device Regulators Forum's risk classification framework and the US regulatory system. "We strongly believe that the IMDRF framework must be adapted to the US regulatory paradigm," said AdvaMed Vice President of Technology and Regulatory Affairs Zach Rothstein.
AdvaMed points to issues with FDA's precertification pilot working model
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