Special Analysis: Addressing Key Concerns Around the FDA’s Final LDTs Rule
Experts answer key questions related to laboratory-developed test regulation during G2 Intelligence webinar.
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Experts answer key questions related to laboratory-developed test regulation during G2 Intelligence webinar.
Though potential FDA LDTs regulation has drawn a lot of attention, other efforts could also have long-term effects on how labs do business.
Though IVD and commercial lab Q3 2023 earnings reports held promising signs, Q4 2024 and FY2023 results tell a different story.
Cybersecurity expert explains the importance of such assessments, which simulate malicious attacks to identify IT vulnerabilities.
A new name comes with Lab Industry Advisor, but the goal of helping labs remains the same.
This checklist can help labs monitor their organization’s business arrangements that concern digital pathology to ensure compliance.
Healthcare attorneys explain three digital pathology models for laboratories to be aware of.
Standard 1910.1450 requires labs to have a chemical hygiene plan.
Debate is underway on whether current CLIA review of LDTs properly assesses a test’s likelihood to detect diseases.