US FDA Likely Not 'Significant', Could Be Mostly Spared From Trump's Regulation-Slashing Order
But even though executive order that requires regulatory off sets may only have limited application to FDA, limited, experts warn that it still could prove extremely unwieldly to implement.
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Among those judged eligible are FDA rules governing adverse event reporting and the Unique Device Identification System.
Most FDA and CMS rules would sunset after 10 years unless action is taken by the agency under a new HHS proposed rule designed to enforce retrospective regulation review. Some experts worry this could allow an administration to skirt traditional notice and comment periods before rule rescissions. The implementation of the rule would likely look very different at FDA than at CMS, experts added.
White House says all guidances, as well as proposed rules, must be submitted to OMB for a determination whether they are major or minor.