FDA Moves to Boost IVD Competition by Reclassifying Tests
The U.S. Food and Drug Administration (FDA) has initiated a process to reclassify certain in vitro diagnostics (IVDs). This move aims to increase competition and access to these crucial tests, and it may relate to the upcoming regulation of laboratory-developed tests (LDTs).
The FDA plans to reclassify most IVDs from Class III to Class II. This change will allow manufacturers to seek marketing authorization through the 510(k) clearance pathway, rather than the more stringent premarket approval (PMA) pathway. The reclassified IVDs will include most infectious disease and companion diagnostic IVDs.
The reclassification process began in early January 2023, with the specific institution announcing this not yet identified. The FDA aims to complete this process before high-risk LDTs are subject to FDA premarket review. This timing could be linked to the anticipated final rule to regulate LDTs.
The FDA will continue using a risk-based approach when initially classifying IVDs. In June 2023, the FDA launched a voluntary pilot program to enhance the performance of LDTs in identifying cancer biomarkers.
The reclassification of IVDs could potentially lessen the burden on laboratories and the FDA in preparing and reviewing premarket submissions for LDTs. This change is expected to increase competition and access to important IVDs, ultimately benefiting patients.
