Federal regulators recently confirmed that Dec. 4 remains the deadline for public comment on the proposed rule that the federal Food and Drug Administration (FDA) would use to regulate laboratory developed tests (LDTs). This was confirmed during a public webinar for the lab and in vitro diagnostics (IVD) industry conducted by the FDA’s Center for […]
November 13, 2023, Intelligence: Late-Breaking Lab News
- By Robert Michel
- > From the Volume XXX, Number 16 - November 13, 2023 Issue
- Tags: Center for Devices and Radiological Health, Depart of Defense, DNA Genotek, Fairview Health, FDA, Food and Drug Administration, GeneDx, Genomic Health, Illumina, in vitro diagnostics, Invitae, IVD, Joel T. Moncure, Joint Pathology Center, JPC, laboratory-developed test, ldt, machine learning, Mark Lyman, MedTech Dive, Melanie Duquette, Phil Febbo MD, Presbyterian Healthcare Services, proposed rule, Sanford Health, UCSF, UnityPoint Health, Varian Medical Systems, Veracyte
