In a stunning turn of events, the U.S. District Court for the Eastern District of Texas ruled in favor of the Association for Molecular Pathology (AMP) and vacated the U.S. Food & Drug Administration’s (FDA) final rule that would have regulated laboratory-developed tests (LDTs) as medical devices under the Federal Food, Drug, and Cosmetic Act. “The Laboratory Plaintiffs contend that FDA’s final rule must be vacated under the Administrative Procedure Act because it exceeds FDA’s statutory jurisdiction, authority, or limitations.”1
The court’s decision halts the FDA’s planned phaseout of its long-standing enforcement discretion. For now, laboratories are no longer required to follow the new five-stage compliance framework that had been published in May 2024. But this ruling doesn’t eliminate the concerns that motivated the FDA’s push: patient safety, regulatory clarity, and modernization of lab practices. This ruling marks a pivotal moment in the ongoing conversation about the regulation of laboratory-developed tests (LDTs). While it represents a notable outcome for those advocating LDT autonomy, it also underscores the evolving nature of clinical laboratory oversight.2
Given the heightened awareness surrounding LDT regulation, it’s likely that additional policy developments will emerge in the coming months or years. Regardless of the outcome, laboratories should remain proactive — reinforcing their quality systems, strengthening documentation, and modernizing validation practices to meet both current expectations and future regulatory demands.2
This ruling represents a significant victory for proponents of LDT independence. There are potential next steps the FDA could take:
- Appeal by the FDA: The U.S. Department of Justice may appeal the decision to the Fifth Circuit Court of Appeals, which could potentially reinstate the rule.
- Legislative action: Congress may pass legislation explicitly authorizing FDA oversight of LDTs, such as a future version of the VALID Act. The VALID Act, also referred to as the IVCT-In Vitro Clinical Test Development Act of 2023, is a bill that requires the FDA to regulate in vitro clinical tests (IVCT). This act would define the FDA’s authority to regulate LDTs. A separate category will be created that separates products from tests from medical devices. The aim of the VALID Act is to ensure that any test, no matter where it is developed, meets the same quality and performance standards. 3
Given these possibilities, clinical laboratories should remain proactive in strengthening their quality systems and validation processes to ensure continued compliance and excellence in patient care.
While the court’s decision to vacate the FDA’s LDT rule removed the immediate regulatory pressure, the importance of data integrity and rigorous validation processes in the clinical laboratory remain as critical as ever. Regulatory uncertainty will likely continue, whether through future FDA actions, new legislation, or evolving payer expectations. In the meantime, the intent behind the rule — improving quality, increasing transparency, and protecting patient safety — still resonates throughout the industry.
A review of current validation/verification requirements
The regulatory structures of CLIA and FDA are different in focus, scope and purpose, but the two regulatory structures are meant to complement each other. CLIA requires labs to validate key performance characteristics of LDTs — such as accuracy, precision, sensitivity, specificity, and reportable range — based on their own staff, equipment, and patient population. These validations are lab-specific and not transferable.4 See Table 1 for a summary of CLIA and CAP (College of American Pathologists) verification requirements for FDA-approved/cleared tests. See Table 2 for a summary of CLIA and CAP validation requirements for LDTs.
This is a prime opportunity for labs to future-proof their processes. Investing in better validation tools, strengthening documentation, and modernizing quality systems will not only reduce audit risk but also accelerate innovation, improve patient care, and prepare your lab for whatever comes next. As regulatory expectations grow, now is the time for laboratories to explore tools that not only reduce the burden, but also enhance quality — all while freeing up staff to focus on other high-impact initiatives.7
Next generation software example for verifying and validating instruments and assays
A cloud-hosted, software-as-a-service (SaaS) solution can automate laboratory verifications and validations. Labs that previously relied on spreadsheets and manual processes can now centralize their quality efforts with auditable workflows, significantly reducing the risk of human error.
Here’s an example of a modern, web-based solution designed specifically to reduce the burden of validation and verification studies. With an intuitive interface and built-in workflows, platforms like this have helped laboratories complete validation and verification studies up to six times faster than traditional tools (See Figures 1 and 2). Note: This example is for illustration purposes only and does not endorse a specific vendor.
Key benefits with advanced validation/verification software:
Summary
Even without a federal mandate, laboratories face ongoing scrutiny from accrediting organizations, healthcare systems, and patients. Prioritizing data quality, automating validation, and committing to continuous improvement are not just about meeting regulatory expectations — they are essential to delivering accurate, high-quality diagnostics that support better patient care.
At the same time, efforts to improve oversight must strike a thoughtful balance: safeguarding patient safety without creating unnecessary barriers to timely, cost-effective access to critical laboratory services.
References
1. Association for Molecular Pathology. LDT opinion. March 31, 2025. Accessed April 1, 2025. https://www.amp.org/AMP/assets/File/advocacy/FDA%20Final%20Rule/LDT_Opinion_3_31_2025.pdf?.
2. Association for Molecular Pathology. Association for Molecular Pathology celebrates U.S. District Court’s decision to vacate FDA rule on laboratory-developed test procedure regulation. Published March 31, 2025. Accessed April 1, 2025. https://www.amp.org/about/newsroom/press-releases/2025/association-for-molecular-pathology-celebrates-u-s-district-courts-decision-to-vacate-fda-rule-on-laboratory-developed-test-procedure-regulation/.
3. Allen J, Lacasse L. Better lab test standards can ensure precision medicine is truly precise. STAT. November 30, 2022. Accessed April 1, 2025. https://www.statnews.com/2022/11/30/valid-act-improve-standards-lab-tests-precision-medicine/.
4. Centers for Medicare & Medicaid Services (CMS). LDT and CLIA Frequently Asked Questions. Accessed April 1, 2025. https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/LDT-and-CLIA_FAQs.pdf.
5. Centers for Medicare & Medicaid Services (CMS). Clinical Laboratory Improvement Amendments (CLIA). Updated January 16, 2025. Accessed April 1, 2025. https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA.
6. College of American Pathologists. All Common Checklist. Updated 2023. Accessed April 1, 2025. cl-com.pdf.
7. Interpretive- BYG4lab. Validation Manager: Toward Smarter Verifications. Accessed April 1, 2025. https://finbiosoft.com/ebook-towards-smarter-verifications/.
