The U.S. Food and Drug Administration (FDA) published a final rule overhauling its approach to the regulation of laboratory developed tests (LDTs) on May 6, 2024. The final rule, which is largely similar to the proposed rule that was issued seven months prior in October of 2023, makes it explicit that LDTs will be considered medical devices regulated as in vitro diagnostics (IVDs) under the Federal Food, Drug, and Cosmetic Act (FDCA). Over a four-year period, the FDA will phase out its general enforcement discretion approach to LDTs, under which LDTs may be marketed without FDA premarket review. However, the FDA outlined targeted enforcement discretion policies for certain categories of tests manufactured by laboratories. 

This rule does not align with the modernized regulatory framework we have been advocating for through the Verifying Accurate Leading-Edge In Vitro Clinical Tests (IVCTs) Development (VALID) Act, but we are hopeful this rule is the first step toward comprehensive reform of the diagnostic test regulatory framework. 

The FDA hosted a webinar on May 14 summarizing the final rule. Slides are available now and the full presentation and transcript should be posted by May 24. The FDA has updated its webpage for LDTs to add a table that clarifies the categories of LDTs discussed in the final rule and to illustrate how the five phaseout policy stages apply to each IVD category.  

AdvaMed Statement 

AdvaMed, the Medtech Association, released the following statements from President and CEO Scott Whitaker and Zach Rothstein, Executive Director of AdvaMedDx, on FDA’s final rule for Laboratory Developed Tests (LDTs): 

“We appreciate FDA’s commitment to ensuring the safety and effectiveness of in vitro diagnostic tests, regardless of their source, which is what today’s rule would accomplish,” Whitaker said. “We hope this rule is just the first step toward comprehensive reform of the framework for diagnostic test regulation overall, which the VALID Act would accomplish through Congress. This reform is critical to supporting the continued innovation of safe, effective, and high-quality diagnostic tests.” 

“This rule represents significant progress in ensuring that diagnostic tests, regardless of where they were developed, meet FDA’s rigorous standards for safety and effectiveness,” Rothstein said. “We also encourage Congress to pass the bipartisan VALID Act, which would establish a modernized, diagnostics-specific regulatory framework for all diagnostics tests. We remain committed to advocating for this important legislation and we look forward to continuing our collaboration with Congress and all stakeholders in these efforts.” 

Verifying Accurate Leading-Edge IVCT Development (VALID) Act 

For years, Congress has been urged by a growing coalition of state life sciences associations, patient groups, and other stakeholders, to enact legislation that will modernize the FDA’s regulation of diagnostic tests, giving the agency the authority, the framework, and the resources to balance proper oversight with advancement of innovation.  

In 2023, lawmakers began pushing again for the creation of a program to modernize FDA regulation of diagnostic tests through the Verifying Accurate Leading-Edge In Vitro Clinical Tests (IVCTs) Development (VALID) Act. The VALID Act of 2023 (H.R.2369), bipartisan legislation introduced in March 2023 and cosponsored by Rep. Diana DeGette (D-CO-1), was another opportunity for Congress to act on comprehensive diagnostic regulatory reform that failed to move forward in 2023. 

Under this new, modernized framework, the unique characteristics of diagnostic tests would be differentiated from medical devices. Hospitals and laboratories could submit their technologies for electronic review, and diagnostics developed to address an unmet medical need could be expedited, speeding high-quality, reliable, and innovative tests to providers and patients, while providing the FDA with tools to administer effective oversight of these tests.   

CBSA position and engagement: CBSA supports the VALID Act and continues to strongly advocate for it along with our national partners. Modernization of the regulation of all LDTs and IVDs under a single, predictable, diagnostic-specific, and risk-based regulatory framework is needed to foster innovation, embrace scientific advances, ensure consistency in development, accuracy, and reliability of all tests, and advance patient care and public health. CBSA applauds Colorado Congresswoman Diana DeGette for her tireless leadership in working with key stakeholders to shape and champion this important legislation.  

Although the FDA’s new final rule simply regulating LDTs as IVDs and phasing out the FDA’s general enforcement discretion approach to LDTs does not align with the modernized regulatory framework we have been advocating for through the VALID Act, we hope this rule will serve as a first step toward more holistic reform.