2019 - Where FDA Is Heading in Regulating Laboratory-Developed Tests

Regulatory requirements under CLIA
FDA’s interpretation of its authority to regulate lab tests under the Food Drug & Cosmetic Act
FDA’s reasoning for applying enforcement discretion to LDTs
The agency’s plan and subsequent proposed guidance to regulate a newly defined subset of LDTs, In Vitro Diagnostic Multivariate Index Assays (IVDMIAs)
FDA’s position for issuing warning letters to labs regarding marketing of specific tests
FDA approach under its proposed regulatory framework for LDTs
Industry’s reasoning for opposing FDA oversight of LDTs
Rationale for the agency’s decision to withdraw its proposed regulatory guidance of LDTs
FDA latest thinking on “possible approach” to regulating LDTs
How possible new federal legislation would impact LDT oversight
Outlook for further regulation of LDTs by FDA and/or Congress