FDA officials are distancing themselves from an upcoming Institute of Medicine report that is expected to call for sweeping changes of the agency's 510(k) premarket review process, according to a report by Mass Device.
FDA commissioner Margaret Hamburg, MD, told a Senate committee that the IOM report would provide guidance only and should not be seen as a blueprint for future changes to the program.
Earlier, agency officials said the FDA was "not bound" by the IOM's recommendations and "will consider them and make its own decisions."
Read the Mass Device report on the 510(k) approval process.
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