governing personnel - Geunim

The Complex World of Diagnostics Regulation: FDA & LDTs

Article Overview & Regulatory Focus Topic: Diagnostics Regulation in the United States Primary Regulator: The U.S. Food and Drug Administration (FDA) Current Hot Topic: The shift in regulatory approach toward Laboratory Developed Tests (LDTs) and the subsequent legal challenges. Audience Insight: This post is designed for executives, compliance officers, and legal experts in the medical […]

510(k), and the recent, CDRH, civil penalties, CLIA '88, compliance officers, De Novo, Diagnostic Testing, Drug, FDA, FDCA, genomic testing, governing personnel, II, including IVDs, instruments, judicial challenge, labeling, manufactured, manufacturing, medical devices, Moderate, monitor, or high complexity), or III based on risk, packaging, premarket pathways, QSR, quality control, quality systems, use, volume