FDA Lays Out Possible Risk-Based Approach To LDT Oversight

FDA released Friday (Jan. 13) a discussion paper outlining a possible approach to laboratory developed test (LDT) oversight that gives both CMS and FDA a place in regulating the tests, but applies a risk-based framework phased in over four years and grandfathers in previously marketed LDTs. The agency also expresses interest in expanding its third-party premarket review program so premarket inspections could be conducted by third parties already conducting CMS oversight inspections of clinical labs. An industry lawyer close to...