Executive Summary | Analysis of FDA Final Rule on Laboratory-Developed Tests

Introduction:

The FDA has issued a comprehensive final rule that redefines the regulatory framework for laboratory-developed tests (LDTs) as medical devices. This rule significantly alters the oversight of these diagnostics, impacting manufacturers and healthcare providers. McDermott Consulting recently published a detailed analysis of the final rule for LDTs.

Key Points:

• Regulatory Shift: The rule clarifies that in vitro diagnostics (IVDs) are considered medical devices under the Federal Food, Drug, and Cosmetic Act, including those manufactured within clinical laboratories.
• Phase-out of Enforcement Discretion: The FDA plans to gradually phase out its previous lenient enforcement over four years, enforcing more stringent compliance requirements in stages.
• Exemptions and Enforcement Discretion Policies: FDA intends to continue the general enforcement discretion approach and generally not enforce any applicable requirements for certain LDTs, including those with pre-1976 designs, certain Human Leukocyte Antigen (HLA) Tests for transplantation, forensic tests, and Department of Defense (DoD) and Veterans Health Affair (VHA) LDTs.  FDA generally intends to exercise enforcement discretion with respect to premarket review requirements for LDTs approved by New York State CLEP, and certain modified versions of another manufacturer’s 510(k) cleared or De Novo authorized test.
• Impact on Current and Future LDTs: The rule limits the modifications allowed on existing LDTs without needing new FDA approval and outlines the consequences for non-compliance.
• Comparison with European Regulation: Similar regulatory shifts are occurring in Europe under the In Vitro Diagnostics Regulation (IVDR), although with different timelines and specific requirements.

Summary:

This final rule marks a pivotal change in how laboratory-developed tests are regulated in the United States, aligning them more closely with other medical devices and potentially affecting the availability and development of these diagnostics. Stakeholders in the medical and diagnostic fields will need to adapt to these new regulations, which aim to enhance patient safety and test reliability.

For detailed commentary from XiFin’s Lâle White, Executive Chair and CEO and Kyle Fetter, Chief Operating Office, tune into the UBS-sponsored audiocast here.