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.
Related Articles on FDA Oversight of Medical Devices:
Group Says Upcoming Device Report Will be Biased
Journal Editors Blast Studies Used by Critics of FDA Device Process
House Committee Chair Accuses FDA of Overregulating Devices
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