Devices & Diagnostics

Will FDA step in with lab development tests?

In her speech at Advamed 2013, FDA Commissioner Dr. Margaret Hamburg said a new challenge will be regulating in some way lab development tests. Now, LDTs are left to CLIA, which, Hamburg said,¬†does not ensure they are properly designed, consistently assembled or clinically valid. She called for a “critical baseline” of these sorts of in […]