Tech Law

A collection of 14 posts
Understanding the Legal Landscape of FDA Regulation on Laboratory-Developed Tests Amidst Ongoing Litigation
Regulatory Compliance & Legal Risk Management

Understanding the Legal Landscape of FDA Regulation on Laboratory-Developed Tests Amidst Ongoing Litigation

As the FDA seeks to regulate laboratory-developed tests (LDTs) as medical devices, legal challenges are emerging that pose significant implications for technology startups. Understanding this evolving legal landscape is crucial for compliance and operational strategy as the new administration may shift regulatory priorities. Definition and Purpose of Laboratory-Developed Tests (LDTs)
4 min read