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US FDA Chief Favors LDT Approach In Bucshon-DeGette Bill

Executive Summary

FDA Commissioner Scott Gottlieb told Reps. Larry Bucshon, R-Ind. and Diana DeGette, D-Colo., that he favors their approach to regulating laboratory developed tests, as spelled out in their draft Diagnostics Accuracy and Innovation Act bill released last spring. The traditional device approval process is a "poor fit" for LDTs, he added.

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