More to FDA’s IVD reclassification than meets the eye

FDA’s move to downgrade the risk classification of most high-risk IVDs comes as the agency prepares to finalize a proposed rule seeking to regulate LDTs — one that will almost certainly face legal challenges. It’s the latest development in a decades-long battle of LDT regulation. 

FDA announced on Jan. 31 its intention to reclassify most class III in vitro diagnostics (IVDs) into class II, clarifying that most of these tests are infectious disease and companion diagnostic IVDs — a type of test for which marketing authorization must usually be obtained at the same time as the corresponding drug is approved. ...