The election results raise many questions about potential changes to FDA’s enforcement priorities.
During the campaign and the transition to date, President-Elect Trump and his surrogates have expressed intentions to change FDA enforcement in the areas of food safety, prescription drugs, and vaccines. No statements have been made about devices or diagnostics generally, or LDTs specifically. Though the new administration is likely to change the current course of LDT regulation, that is not guaranteed.
The LDT final rule, which regulates laboratories as device manufacturers and LDTs as devices, took effect on July 5, 2024. It remains in effect. FDA’s definition of IVDs, at 21 C.F.R. § 809.3(a), has already been amended to include “when the manufacturer of those products is a laboratory.” The agency’s enforcement timeline under the final rule’s phaseout policy also remains on track. Thus, laboratories should still plan to comply with the Stage 1 requirements by May 6, 2025.
Pending Lawsuits to Vacate the Final Rule
The lawsuits against FDA, filed by ACLA and the AMP, are pending. No rulings have been made by the court. Both ACLA and AMP are seeking to (1) vacate the final rule, (2) declare that the agency is not authorized to regulate LDTs as devices, and (3) enjoin FDA from enforcing the final rule. These cases are proceeding to summary judgment, which is expected in early 2025. Laboratories cannot assume that ACLA and AMP will prevail. These associations made strong cases in their filings, but a positive ruling is not guaranteed.
How Could the New Administration Change the Current Course of LDT Regulation?
The Trump administration will probably not take action with respect to the LDT final rule until a ruling in the lawsuits against FDA. As president, Trump cannot rescind a regulation by Executive Order. If the administration wants to rescind the LDT final rule, FDA would have to go through notice-and-comment rulemaking. In that case, the agency would propose a new rule to restore the prior definition of IVDs, and stakeholders would have the opportunity to comment. Because devices and diagnostics do not appear to be a priority for the new administration, it is not likely FDA would proceed with such rulemaking anytime soon.
However, if ACLA and AMP prevail on one or more counts, Trump’s FDA is not likely to appeal the ruling. If FDA prevails on one or more counts, Trump’s FDA would probably not enforce the Stage 1 deadline of the final rule, and could be prompted to act on the issue more broadly.
There are New Opportunities for Congress to Act
Congress is not likely to take any official action regarding the LDT final rule before the end of the current term. After the new session begins, it is possible that new legislation, which provides an alternative regulatory framework for LDTs and all clinical laboratory tests, will be introduced. It is more likely that such legislation can pass. Republicans have gained the majority in the House and Senate, and early champion of the VALID Act, Rep. Diana Degette, retained her House seat. Senator Bill Cassidy, who has repeatedly questioned FDA’s authority to regulate LDTs, holds his seat through at least 2026. A Trump administration may work with Congress to deviate from existing regulatory frameworks for IVDs generally and LDTs specifically. New legislation, however, could take months or years.
In sum, laboratories cannot assume that the LDT issue will be a high priority for President Trump, FDA, or Congress. Laboratories should continue to plan for compliance with the LDT final rule’s Stage 1 enforcement deadline, but should take advantage of opportunities to engage with Congress, including with newly elected representatives and senators. Laboratories and other stakeholders should focus on developing legislation that provides alternatives to the current regulation of LDTs and IVDs and supports innovation.
Christine P. Bump
Principal and Founder
Penn Avenue Law & Policy
Christine Bump is a regulatory attorney with nearly two decades of experience developing and implementing FDA strategies for devices, diagnostics, and digital health platforms. She served as regulatory counsel for a national coalition of diagnostic companies and is a prolific author and speaker in the field. Before establishing her firm, she worked at Goodwin Procter LLP and Hyman, Phelps, and McNamara, P.C. Christine earned a B.A. from Sweet Briar College, an M.P.H. from Emory University’s Rollins School of Public Health, and a J.D. from Emory University School of Law.
Quadax Statement on LDT Final Rule Compliance
At Quadax, we understand the significant challenges laboratories face in light of the uncertainty
surrounding the LDT Final Rule. The upcoming requirement to comply with Stage 1 by May 2025 will
likely increase compliance costs and may impact patient access to critical tests.
As an experienced Revenue Cycle Management (RCM) partner, we urge laboratories to stay
engaged with industry groups and lawmakers to advocate for a regulatory framework that balances
compliance with financial sustainability. At Quadax, our focus is on helping laboratories navigate
these challenges, mitigate risks, and adapt to the evolving landscape. By optimizing reimbursement
strategies, we aim to safeguard financial health while supporting regulatory compliance.
Schedule a strategy call with our RCM team here to discuss how we can assist your laboratory in
preparing for this new era.
