PROPOSED FDA AUTHORITY OVER LAB-DEVELOPED GENETIC TESTS WORRIES SOME
The FDA's proposal to regulate complex genetic laboratory-developed tests (LDTs) could stifle the development and marketing of new diagnostics, presenters said at a recent public meeting.
Manufacturers, laboratory directors, physicians and patients want the agency to reconsider its proposal to regulate in vitro diagnostic multivariate index assays (IVDMIAs) -- LDTs that examine numerous genes simultaneously using computer algorithms to measure results.
Under the current system, test "kits" are regulated by the FDA while LDTs are regulated by the Centers for Medicare & Medicaid Services under the Clinical Laboratory Improvement Amendments.
Debate during the Feb. 8 meeting centered on draft guidance issued by the FDA in September 2006 suggesting IVDMIAs should be classified as medical devices, which would allow the FDA to regulate them either as Class II devices requiring premarket notification or as Class III devices requiring premarket approval.