Part 1: Legal and Regulatory Challenges with Diagnostic Tests in the United States (US), including Laboratory Developed Tests (LDTs)

Meeting attendees overviewed and discussed the history of LDT regulation, shifting approaches to LDT regulation before and during the COVID-19 pandemic, strategies for navigating LDT regulation, and the relevance of FDA’s investigational device exemption framework to the regulation of LDTs.

Deliverables