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FDA Approach To Least Burdensome Critiqued By Device Industry Task Force

This article was originally published in The Gray Sheet

Executive Summary

FDA's use of postmarket studies as a condition of approval for two transmyocardial revascularization devices is a fitting example of how to apply the "least burdensome" principles to the device review process as mandated by the 1997 FDA Modernization Act, suggests a coalition of medical device organizations.

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