510(k) - Geunim – Law Together

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

Navigating US Health Technology Regulation & Compliance

Meta Description: The regulatory landscape for health technology—including AI, SaMD, and connected devices—is rapidly evolving. Learn about FDA oversight (510(k), PMA), key compliance areas (HIPAA, cybersecurity), and the shift toward risk-based frameworks. Understanding the Complex Web of Health Technology Regulation The health technology sector is revolutionizing care delivery, driven by innovations like Artificial Intelligence (AI),

510(k), 510(k) Clearance, and the Stark Law, bias, Bias Mitigation, cybersecurity, Data Integrity, developers, Drug, efficacy, ethical, FDA Regulation, health plans, HIPAA Compliance, HITECH, HITECH Act, injunctions, marketed, medical advice, medical expert, PMA), product recall, SaMD, Stark Law, transparency, treatment