81 Days: Countdown to Stage 1 Compliance for the FDA's LDT Final Rule
A question for labs with LDTs on the market: are you ready?
Editor’s note: The compliance playbook provided in this guide was adapted from a resource developed by he Association for Mass Spectrometry & Advances in the Clinical Lab (MSACL) Compliance and Accreditation Committee (CAC). Visit their resources page for a list of draft template documents available for download to assist with compliance.
Today, a message to all lab managers among us with LDTs on the market: time is running out. Here’s where things stand with the FDA’s Final Rule on Laboratory Developed Tests (LDTs).
Long story short, the May 6, 2025 deadline for Stage 1 compliance is still on.
By that date, you’ll need to be:
Reporting any adverse events or product problems associated with LDTs to the FDA following the Medical Device Reporting (MDR) requirements.
Notifying the FDA of any corrections or removals of LDTs from the market to address safety issues.
Maintaining and managing records of complaints related to LDTs, ensuring proper documentation and investigation.
That said, two lawsuits challenging the FDA are in progress. The American Clinical Laboratory Association (ACLA) and the Association for Molecular Pathology (AMP) have each filed lawsuits challenging the Final Rule, which have been consolidated in the U.S. District Court for the Eastern District of Texas.
The ACLA lawsuit was filed on May 29, 2024, and contends that the FDA's Final Rule exceeds the agency's statutory authority under the FDCA. The ACLA argues that laboratory testing services are professional services regulated under the Clinical Laboratory Improvement Amendments (CLIA) by CMS, not medical devices subject to FDA oversight. The association also claims that the FDA acted arbitrarily and capriciously, violating the Administrative Procedure Act (APA), by not adequately addressing industry comments and failing to provide sufficient rationale for its regulatory approach.
The AMP lawsuit was filed on August 19, 2024, echoing similar concerns. AMP asserts that the FDA's regulation of LDTs as medical devices is an unprecedented expansion of authority that threatens patient health by imposing burdensome compliance costs and stifling innovation, particularly in smaller laboratories serving rural areas. The organization also argues that the FDA's rulemaking process was arbitrary and capricious, lacking adequate justification and failing to consider existing regulatory frameworks under CLIA.
Oral arguments are scheduled for just a few days from now — February 19 — in the U.S. District Court for the Eastern District of Texas. As reported by the wonderful Christine Bump over at Penn Avenue Law & Policy, many who are following these cases expected the judge to rule solely on the motions and briefs already submitted. However, on January 17, the plaintiffs (ACLA and AMP) requested an oral hearing, emphasizing the case’s significant legal and regulatory implications for clinical labs and healthcare practitioners. The FDA did not oppose the request, and the judge quickly scheduled the argument.
While this may delay the ruling, a decision could still be handed down before the Stage 1 compliance deadline of May 6, 2025. The case remains pivotal in determining the FDA’s regulatory authority over LDTs and could set a broader precedent for agency rulemaking.
If you’re interested more about the ongoing legal battle over this FDA rulemaking, The National Law Review has a great explainer from the end of last year.
If you're not banking on the rulemaking being overturned before the May deadline, you have just a few weeks to comply with Stage 1 requirements.
A high-level playbook for Stage 1 compliance
Here's a high-level playbook you can execute between now and May 6, adapted from an excellent set of resources developed by the Association for Mass Spectrometry & Advances in the Clinical Lab (MSACL) Compliance and Accreditation Committee (CAC). Visit their resources page for a list of draft template documents available for download to assist with compliance.
Contact us to pair you with a qualified regulatory consultant who can help you adapt and implement this plan in your operation.
Keep in mind that the information below serves only general informational purposes and should not be interpreted as legal advice. Regulatory rules and compliance requirements can differ significantly depending on individual circumstances. It's crucial to seek consultation from a qualified attorney or regulatory expert who understands your specific situation and can offer tailored guidance before making any decisions based on the information provided here. Again, get in touch with us to find the professional you need.
A few guiding principles
Whenever possible, use existing structures for compliance, such as job titles/roles, committees, processes, procedures, and review/reporting/approval conventions, rather than creating new entities or documents.
Rename and modify what is currently in use, incorporating both standard clinical laboratory language and FDA LDT Final Rule compliant language. Add new functions as necessary.
Consult and, where appropriate, implement features from your existing clinical laboratory QMS to address aspects of LDT Final Rule compliance that are novel to your facility (e.g., ISO 13485:2016 Medical Devices–Quality Management Systems and CLSI QMS14, QSRLDT). These upgrades may prove valuable regardless of the ultimate fate of the FDA LDT Final Rule.
MDR (Medical Device Reporting)
Obtain an FEI number from the FDA. This is required for the eMDR. There’s no fee. Standard processing time is 7-10 days if submitted without errors, but we suggest planning for longer timelines. Email feiportal@fda.hhs.gov to request one. In your email, provide your company name, business address, contact information (name, email, and phone number), reason for request (e.g., “needed for eMDR submissions”). The FDA will assign an FEI and respond via email.
Establish an eMDR account with the FDA. The FDA has detailed step-by-step guidance that walks you through the process here.
Develop an MDR SOP that either references a separate SOP or defines a formally designated unit for complaints review. Include comprehensive guidance for completing all fields in the online MDR form. (You’ll likely want a consultant’s help putting these SOPs together to ensure they’re both practical and compliant.)
Within the MDR SOP, include FDA LDT Product codes (UPC), Unique Device Identifiers (UDI), Adverse Event codes, and generic use of 2177 for Premarket Submission Numbers as applicable for all LDTs.
Designate, train, and verify competency for primary and backup personnel responsible for entering online MDRs. Expect FDA investigators to interview your staff during inspections.
Complaints
Establish a formally designated unit responsible for reviewing and implementing corrective actions related to LDT complaints, nonconforming events, corrections, and removals.
Specify a chairperson and members by job title and reference all required FDA reporting. Include either a committee member or establish a consulting relationship with someone qualified to make medical judgments regarding causal or contributory relationships between LDT results and patient adverse events (death or serious injury). The FDA defines qualified persons as physicians, nurses, risk managers, or biomedical engineers.
Obtain UDI codes and establish UPC for all your LDTs on the market. Reference the FDA’s Laboratory Developed Tests: Small Entity Compliance Guide and this summary of the FDA’s webinar on LDT requirements under the Final Rule.
Create an SOP for the LDT QA committee SOP if not already included in the MDR or complaints SOPs.
Develop or modify a complaints SOP, including references to the LDT QA committee SOP.
Design and implement a complaints form (it should be available in both hard copy and online formats).
Train staff and verify competency for all personnel who will record and respond to complaints, emphasizing timely reporting to the LDT QA committee within 5-day and 30-day MDR deadlines.
Corrections and removals
Develop a corrections and removals SOP (referencing your LDT QA committee). Include detailed process documentation (such as flow charts) for method investigation appropriate to your testing methodology. Define “removal” as temporarily ceasing internal testing with the cited LDT and redirecting samples to another laboratory until corrections are validated, implemented, and required FDA reporting is completed. Include the 10-day FDA reporting deadline requirement.
Designate, train, and verify competency for primary and backup personnel responsible for FDA online corrections and removal reporting.
Where a consultant can help
The initial setup and strategic planning phase is particularly critical. You’ll want to work with a consultant who can perform a comprehensive gap analysis of your current systems against FDA requirements and create a clear roadmap for implementation, helping your team understand which existing systems can be leveraged versus where new processes need to be created. Their expertise can be especially valuable in navigating the initial administrative setup with the FDA, including obtaining FEI numbers and establishing eMDR accounts correctly the first time.
The right consultants can also guide the design of the LDT QA committee structure, advise on qualified medical reviewer requirements, and establish effective workflows between committees and reporting systems. You’ll want to make sure you have clear lines of authority and responsibility from the outset.
Perhaps the most complex area where consultant expertise is crucial is building documentation systems. This includes creating MDR SOPs that meet FDA requirements, developing compliant corrections and removal procedures, and establishing documentation systems that integrate smoothly with existing laboratory processes.
Training development is another key area where consultant expertise is highly valued. This includes creating FDA-aligned training programs for staff, conducting mock FDA inspections, training key personnel on MDR submission requirements, and developing effective competency assessment protocols.
Finally, consultants provide crucial guidance at critical decision points in the compliance process — determining when to submit MDRs, making decisions about test corrections versus removals, evaluating the need for FDA reporting, and assessing complaint severity and required response. They understand FDA expectations from direct experience, can identify common pitfalls before they become issues, know how to integrate FDA requirements with existing laboratory operations, and can ensure compliance without over-engineering systems.
Need expert LDT compliance support? We can help.
The FDA's new LDT regulations present complex compliance challenges. Our team of industry veterans and former FDA staff can help guide your laboratory through these changes, from initial gap analysis to full implementation.
Our team of industry veterans and former FDA staff offers:
Comprehensive gap analysis of your current systems against FDA requirements
Strategic implementation planning aligned with compliance deadlines
Quality system development and integration with existing CLIA frameworks
Staff training and mock FDA inspection preparation
Documentation system optimization
Ongoing compliance support and updates
Learn more and contact us to start the conversation on how we can support your transition.
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