The Food and Drug Administration, in collaboration with the Federal Communications Commission and the Office of the National Coordinator for Health Information Technology, will soon publish a proposed strategy and recommendations on a risk-based regulatory framework for health IT, FDA Commissioner Margaret Hamburg, M.D., told a Senate committee hearing this morning. The report, mandated under the Food and Drug Administration Safety and Innovation Act (FDASIA), was due to Congress by January but has been delayed.
"Implementing FDASIA is a considerable undertaking, requiring detailed planning to integrate these tasks with the rest of FDAs workload. All told, the 140-page law called for multiple deliverables of all types, including more than 30 proposed and final rules, more than 40 draft and final guidance documents, more than 20 reports to Congress, and many other additional reports," according to Hamburg's testimony before the Senate Health, Education, Labor and Pensions Committee.
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