CEO SUMMARY: 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 […]
FDA Reviews Oncology Companion Diagnostics
Legal experts say a proposal would streamline approvals and boost laboratory innovation
- By Janette Wider
- > From the Volume XXXIII, No. 1 - January 19, 2026 Issue
- Tags: Christine Bump JD, Class II medical device, Class III medical device, Companion diagnostics, FDA, Federal Register, final rule, Food and Drug Administration, genetic variants, in situ, in vitro diagnostics, IVD assay, ivd/lab informatics, laboratory-developed test, ldt, McDermott Will and Schult, Mike Ryan JD, next generation sequencing, nucleic acid biomarkers, oncology, Penn Avenue Law and Policy, PMA, premarket approval
