UPTON/ESHOO DEVICE REFORM BILL DESIGNED TO DRAW ATTENTION TO RISK-BASED CLASSIFICATION OF NOVEL DEVICES, FDA RECOGNITION OF CONSENSUS STANDARDS
This article was originally published in The Gray Sheet
Executive SummaryA stand-alone device reform bill slated to be introduced by Reps. Fred Upton (R-Mich.) and Anna Eshoo (D-Calif.) on April 29 will propose provisions to allow FDA to classify novel technologies according to risk and to clarify FDA's ability to adopt consensus standards.
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