The FDA proposed reclassifying certain nucleic acid‑based companion diagnostics from Class III to Class II, which would allow affected devices to seek clearance via the 510(k) pathway rather than the more burdensome PMA route, according to regulatory coverage. The agency says the move could lower barriers for diagnostic manufacturers to obtain regulatory clearance for oncology companion tests. Stakeholders note the proposal could broaden market participation and speed availability of companion diagnostics aligned to approved oncology therapies, but also raise questions about postmarket surveillance and performance standards. Diagnostic labs, device makers and pharma partners will monitor the rulemaking and may submit formal comments during the agency’s public consultation period. Clarifier: Class II devices are subject to special controls and generally undergo a shorter premarket review (510(k)) than Class III devices, which require a premarket approval (PMA) demonstrating safety and effectiveness.