The traditional device approval process is a "poor fit" for laboratory developed tests, FDA Commissioner Scott Gottlieb told Congress at a Nov. 30 check-in hearing on implementation the 21st Century Cures Act. Gottlieb added that FDA staff will continue to offer technical assistance to help refine a "Diagnostics Accuracy and Innovation Act" defining new regulations for LDTs. His comments came at a hearing before the House Energy and Commerce Health Subcommittee.
"There is an opportunity to fashion a new regulatory framework, through the appropriate legislation, that will be a better fit for the kind of technology we're talking about here," Gottlieb...