This session addresses the landscape for regulatory approval of Laboratory Developed Tests (LDTs) and the potential move from the FDA's current enforcement discretion in this area. In particular, the panel will discuss prospects for legislation establishing a comprehensive regulatory framework for in-vitro diagnostics, including the proposed Diagnostic Accuracy and Innovation Act. Discussion will center on what such a regulatory framework might look like and how FDA regulation of these tests would intersect with CMS' regulation of laboratories under CLIA.

Ability Level: Intermediate

Session ID: 503647