Regulatory attorneys indicate that the FDA’s move to reclassify oncology companion diagnostics to Class II medical devices could speed approvals and reduce costs for submissions. From a business perspective, the proposal could allow clinical laboratories to expand their testing options, bring more tests in house, and attract new investment. The public comment period for the […]
FDA May Reclassify Oncology Companion Diagnostics to Class II Devices
Also in the January 19, 2026 issue, cuts to rural labs boost support for the RESULTS Act
- By Robert Michel
- > From the Volume XXXIII, No. 1 - January 19, 2026 Issue
