FDA’s LDT RULE: Steps to Prepare for Your FDA First Milestone Submission

No single regulatory development will have greater impact on your lab’s clinical service menu and financial performance than the urgent need to comply with the FDA’s LDT rule. With the compliance clock ticking and the first regulatory milestone arriving in May 2025—just seven months from now—you now have the opportunity to learn the most productive steps necessary to protect the LDTs essential to patient care and your lab’s finances!

This second LDT webinar in our well-attended, ongoing series delivers to you and your team a clear path forward for achieving the twin goals of preserving your LDTs with the greatest clinical value while safeguarding the indispensable revenue generated by those same LDT.

Not only will you hear from three nationally-known experts, but you will also have the valuable opportunity to ask your most important questions and get answers specific to your lab’s unique circumstances. This webinar is organized around the three topics that you and your lab team will need to address early in your LDT compliance efforts.

Vital Topic number one addresses the absolutely critical first actions your lab must take to operationalize compliance. This deals with the first question you must answer: Which of your LDTs are highest priority and indespensable to your lab? Given the cost to bring each LDT into compliance, you’ll next learn about options for addressing your lesser priority LDTs, such as using a reference lab that offers the same test. This involves a “make or buy” process as you prioritize your existing menu of LDTs for compliance.

This topic introduces you to the five-part plan to operationalize and review your menu of LDTs as follows:

• End-in-Mind Strategy
• Financial Strategy for Today and at Exit
• Operational Plan
• Categorizing your LDTs into Groups: High Margin, Export Plan, and Import Plan
• Reconciliation of Your Lab’s Financial Plan, Including Identifying High-Risk Factors and Recognition of The Plan’s Upsides and Downsides.

You’ll be guided through the twists and turns of the FDA’s language about “grandfathered” tests marketed prior to May 6, 2024, and why the requirement of “no changes in technology, indications for use, or diminished performance can be landmines for unwary labs.

Vital Topic number two covers the necessary—but often overlooked—elements of the LDT rule, which has many complex elements and a five-year implementation timetable. Here is where you’ll get the necessary checklist of required action items that ensure full and timely compliance. Your expert speakers have years of experience working with the FDA on diagnostic tests and you’ll get those “insider secrets” for effective compliance that can save your team plenty of time and money while ensuring that each LDT is in full compliance with the proper documentation.

Vital Topic number three goes into detail with the the best ways to comply with the FDA’s first milestone, which arrives on May 6, 2025. This is the FDA’s Medical Device Reporting (MDR) system. It includes reporting adverse events, as well as reporting corrections and removals. The MDR system will be new to nearly all labs and differs substantially from the federal CLIA requirements labs have followed for years. Here is an invaluable guided tour that provides you with both a head start on your compliance effort, along with confidence that you will get it right the first time.

You already recognize that the FDA LDT rule has raised the stakes for every laboratory that offers LDTs and relies on the revenue generated by these assays. This webinar will arm you with the right decision-making strategies and steps to use in assessing the LDTs you will keep and those you will put on the back-burner. You’ll then get the necessary action steps to be in full compliance with this complex federal LDT rule. Guarantee your place by registering today!

Take advantage of early bird savings by registering today!