Q&A Exclusive: FDA Commissioner Talks About His Tenure, Recruiting And LDTs
US FDA Commissioner Scott Gottlieb sat down with Medtech Insight and Pink Sheet reporters for an exclusive chat about his ongoing regulatory work and plans for the future.
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While lab-developed test (LDTs) remain under a US FDA enforcement discretion policy, the agency is working on several fronts to offer appealing regulatory pathways for advanced diagnostic services, FDA Commissioner Scott Gottlieb told American Clinical Laboratory Association members.
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.
The agency authorized a next-generation sequencing tumor profiling system that leverages the New York State Department of Health to speed future clearances.