Get Ready to Comply with FDA Final Rule Stages 1 & 2: Yeah, We Mean You

FDA's New LDT Rule: An Overview 

The FDA's final rule aims to phase out the enforcement discretion it has historically applied to laboratory developers of in vitro diagnostic (IVD) medical devices, ensuring Laboratory Developed Tests (LDTs) meet the same strict standards for patient safety as expected from IVDs made by traditional manufacturers. Despite the intent to create a level playing field, the Agency acknowledges the financial and administrative burden this places on CLIA certified or CAP accredited labs, potentially leading to the discontinuation of critical tests. To mitigate this risk, the FDA is staging the phaseout over four years and maintaining enforcement discretion in some scenarios. However, even in these scenarios, compliance with certain medical device reporting (MDR), registration, listing, and labeling requirements is required to monitor and reduce patient harm risks. 

In this post, we posit that regardless of your lab’s longer-term plans, you should plan to comply with Stages 1 and 2. We’ll look more closely at how to begin and what compliance will mean for your operations. 

Stage 1  Requirements 

Under Stage 1, laboratories must comply with the following key requirements: 

• Medical device reporting (MDR) requirements to ensure that adverse events, device malfunctions, and other significant issues related to the performance of LDTs are systematically identified and reported to the FDA. This involves establishing procedures for identifying adverse events and device malfunctions, maintaining detailed records of adverse events, submitting timely and accurate reports to the FDA, and training laboratory staff on MDR procedures and reporting obligations. 

• Correction and removal reporting requirements to ensure that any actions performed on released LDTs to mitigate potential health risks to patients are documented and reported. Laboratories must develop procedures for identifying when a correction or removal is necessary, document all instances of corrections or removals, including the reason for the action and the steps taken, report these actions to the FDA, and implement corrective and preventive actions to prevent recurrence. 

• Complaint file requirements. This involves maintaining a robust quality process for handling complaints about LDTs. Laboratories must establish a system for receiving, documenting, and evaluating complaints, investigate the causes of complaints and determine appropriate corrective actions, maintain detailed records of all complaints and the actions taken to address them, regularly review complaint records to identify trends and areas for improvement, and train staff on the procedures for handling and documenting complaints. 

To meet these requirements, laboratories must establish robust documentation processes, training systems, and reporting mechanisms. Failure to comply with Stage 1 requirements can result in enforcement actions, including potential test removal from the market. 

Stage 2  Requirements

Two years after the publication date of the final LDT rule, laboratories must comply with additional requirements not covered during Stage 1. These include registration and listing requirements, labeling requirements, and investigational use requirements. 

Laboratories must register each site with the FDA and ensure each LDT is properly listed with accurate and up-to-date information. This involves registering the laboratory with the FDA as a medical device manufacturer, submitting detailed listings for each LDT, including information about the test's intended use, performance characteristics, and scientific principles, and maintaining and updating the registration and listing information as necessary.

Additionally, laboratories must comply with FDA labeling requirements to provide clear, accurate, and compliant labeling for all LDTs to ensure proper use and patient safety. This involves developing labeling that complies with FDA regulations, including instructions for use, warnings, and intended use statements, ensuring that labeling is clear, accurate, and easily understood by users, and regularly reviewing and updating labeling to reflect any changes in test performance, intended use, or safety information. 

Lastly, laboratories must determine if their LDT will be used for investigational purposes, and if so, they must meet FDA’s investigational use requirements to protect study subjects and maintain the integrity of clinical investigations. This involves obtaining Investigational Device Exemptions (IDEs) as necessary for LDTs used in clinical investigations, adhering to FDA regulations for informed consent, monitoring, and reporting in clinical studies involving LDTs, and maintaining detailed records of all investigational use activities and complying with reporting requirements. 

As labs decide to adhere to FDA’s requirements for particular assays, near-term compliance with Stage 1 and then Stage 2 requirements in 2025 and 2026 respectively loom large and should be front and center. Is your lab in search of a partner to provide guidance and support as you engage in these activities? Velsera has deep experience supporting compliance consistent with both CLIA and FDA requirements and is confident in guiding its customer labs through Stages 1 and 2. Please get in touch by signing up for our newsletter at the bottom of this page or by writing us at marketing@velsera.com.  

Next time, we’ll take a closer look at bridging the gap between CLIA and FDA regulations as well as how the FDA rule impacts different types of laboratories. 

The information presented here is not intended as legal or regulatory advice but rather as a brief introduction to the subject matter. Compliance with the FDA’s final rule may rely on factors and requirements not listed here, and any person or entity subject to the final rule is encouraged to obtain professional advice specific to their situation.