Navigating Change in LDT Oversight: What Labs Can Take Away from the FDA’s Recent Decision

As you may have heard, the FDA’s rule to regulate lab-developed tests (LDTs) was vacated by the courts on March 31, 2025 and will no longer be enforced. While this decision may have caused some uncertainty, it's important to remember that the fundamental processes labs follow to maintain quality and compliance remain unchanged.

Intelligent Quality Engine (IQE) has always focused on helping labs manage complaints, non-conformances, root cause analysis, corrective actions, and more—well before the FDA’s regulatory spotlight was cast on LDTs. In fact, thousands of labs have been using IQE for years, not because they had to, but because it made their work more efficient, their data clearer, and their teams more aligned.

Now, with the LDT rule vacated, it’s a perfect time to reflect on the progress we've made and the tools that have been put in place to ensure quality care. Complaint management, non-conformance investigations, and corrective actions are still vital to maintaining high standards in the lab. These practices, designed to improve patient outcomes, are not just helpful—they're required under various industry standards, such as:‍

• CAP: COM.12000 (Complaint Handling), GEN.20377 (Complaint Resolution)
• CLIA: 42 CFR §493.1239 – Complaint investigations
• ISO 15189: Sections 4.8–4.12 (Complaints, Nonconformities, Corrective/Preventive Actions)
• The Joint Commission: QSA.02.08.01 – Complaint management process

While the regulatory landscape for LDTs may have shifted, the processes behind quality management in laboratories remain essential. This is where IQE continues to support labs—by providing a platform specifically designed to manage complaints, root cause analysis, and corrective actions, helping laboratories maintain their best practices and compliance.

Built for Flexibility, Designed for Quality

Even as the FDA’s final rule for LDTs was in the works, we didn’t just wait and watch—we got to work. IQE evolved to be even more powerful and flexible, helping labs address quality events across a wide range of scenarios, not just those related to LDTs. We made several upgrades to better meet the diverse needs of labs, including:

• Complaints Workspaces: A centralized hub to streamline intake and jumpstart your investigations
• Public Links: Capture complaints and non-conformance reports from outside your organization, which allows you to manage your entire complaint intake and CAPA
• IQE Form Library: Pre-built templates for complaints, PT failures, change control, SOP deviations, equipment maintenance, safety audits, and more.
• Locations Element: Route and associate complaints/non-conformances to the correct lab site automatically, all coming from your actual lab and site locations.
• Connections Element: Link to related IQE forms, Document Control policies, Compass competency records, and more.
• Task Assignment: Assign follow-ups and corrective actions with due dates to specific users or groups.
• UI Updates: Faster setup, quicker event launches, and easier custom dashboards and reports.

In addition to managing non-conformance and complaint events, we’ve expanded IQE’s template library to support other critical areas such as proficiency testing, change control, equipment maintenance, temperature checks, and safety audits.

We’re Here to Support You, Every Step of the Way

As we continue to navigate this ever-changing landscape, know that we're here to help you make the most of IQE. Whether you're optimizing your current processes or exploring new ways to streamline operations, we’ve got you covered. Keep an eye out over the next couple of weeks as we roll out more helpful resources, including videos, guides, and updates to the Help Center—designed to help you unlock the full potential of IQE.

We’re excited to continue partnering with you to elevate lab quality, stay ahead of standards, and keep things running smoothly—no matter what comes next.

Thanks for reading, and as always, don’t hesitate to reach out if you need anything!