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Least burdensome

This article was originally published in The Gray Sheet

Executive Summary

Draft guidance developed by industry/FDA task force must be reviewed by FDA's Office of Chief Counsel and Office of Policy before being released. The draft is an expansion of the task force's March 2000 "Concepts and Principles" document and includes in vitro diagnostics, according to IDE Section chief Joanne Less. Implementation of least burdensome principles can be expected to result in some inconsistencies in the Office of Device Evaluation's handling of PMAs and 510(k)s, ODE Deputy Director Phil Phillips noted. If certain companies propose a less burdensome approach, "we may accept those and there will be some apparent inconsistency in the program"



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