LDT Oversight Remains Under CLIA, for Now
Judge rules that the FDA has ‘no authority’ to issue its rule governing laboratory-developed tests
Judge rules that the FDA has ‘no authority’ to issue its rule governing laboratory-developed tests
Regulatory expert Julie Ballard shares her thoughts on the most useful resources for labs as they get ready to comply with Stage 1
Although the timelines have been extended several times, IVDR complexity has created a concerning bottleneck in the approval process
Considerations for addressing compliance with Stage 1 of the FDA’s lab-developed tests final rule
Regulatory expert explores whether any exclusions might benefit cancer laboratories trying to navigate upcoming compliance deadlines
Test maker Exact Sciences says it expects Cologuard Plus to cut false positives by more than 30 percent
Understanding the process and implementing proper procedures is the key to ensuring compliance when reporting such events
How the current FDA AI/ML device regulations may be impeding innovation in the clinical lab
FDA seems determined to push ahead with final rule, regardless of CDRH director’s departure, hiring of replacement.
CEO Laurie Menser discusses the Association for Molecular Pathology’s court case against the FDA’s rule on laboratory-developed tests.
The company is hiring at least 100 sales representatives this year to spread awareness and uptake of its recently FDA-approved Shield test