US FDA Chief Favors LDT Approach In Bucshon-DeGette Bill
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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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.
At back-to-back congressional hearings on Feb. 14 and 15, US Health and Human Services Secretary Alex Azar seemed to satisfy lawmakers' questions on how he would use his budget to fix problems in the durable medical equipment bidding program and provide telehealth reimbursements under Medicare, but conceded that lab-developed test regulations are a complicated issue.
Alex Azar was confirmed as the next secretary of Health and Human Services with strong industry support. Azar comes to the role with some homework to do on key FDA medtech policies, but has expressed support for risk-based regulation of lab-developed tests and cost-saving bundled-payment models.