The FDA proposed reclassifying certain nucleic acid–based companion diagnostic assays from Class III (PMA) to Class II (special controls), which would allow manufacturers to pursue the 510(k) pathway for tests linked to approved oncology therapeutics. The agency cited decades of published performance data and a lack of significant postmarket safety signals as justification for lowering premarket burden. If finalized, the reclassification aims to shorten review timelines, reduce regulatory costs, and broaden market entry for developers of sequencing and nucleic-acid amplification–based companion diagnostics. The public comment window is open through Jan. 26, 2026. Clinical labs, IVD companies and oncology sponsors will evaluate implications for test validation, labeling and postmarket surveillance.