FDA’s LDT RULE: Understanding What’s Compulsory, What’s Not!

You already know that FDA’s final rule on Laboratory Developed Tests (LDTs) proposes a radical overhaul of the regulatory framework that has governed these tests since CLIA was enacted in 1988. What you don’t know yet are specific steps your lab must follow with your existing LDTs so that each complies with the new LDT rule—allowing you to continue offering these LDTs to your clients so they continue to produce revenue for your lab.

Another fact about the LDT Rule is that no existing LDTs are “grandfathered.” More importantly, every lab performing LDTs must comply with the FDA’s medical device reporting system as of May 6, 2025. Your lab will need to adopt and use the same FDA adverse event reporting, correction, and removal standards it requires of medical devices. But you and your team only have eight months to comply!

To help you and your team understand the full range of issues, requirements, and action items necessary for compliance, we’ve assembled a panel of three experts who have direct experience in working with federal regulators, including the FDA. Each has an area of expertise directly relevant to helping you comply with the LDT Rule so that you can continue to offer your LDTs with confidence.

First to present will be attorney Emily Johnson (See bio) of McDonald Hopkins,
on these topics:

• General understanding of the FDA LDT Rule; what’s clear, where more agency guidance is needed, and ‘must do’ steps labs must take to keep their LDTs compliant.
• Why you should assess all your lab’s LDTs immediately, recognizing that the LDT Rule “freezes your existing LDT as is. Under the rule as written, further improvements and modifications to that same assay will require resubmission to the agency.
• Understanding the academic medical center and hospital exemption (for inpatients only, excluding outpatient and outreach uses) and legal issues triggered by this section of the FDA Rule.

Next to present will be Sheila Walcoff, CEO of Goldbug Strategies, on these topics:

• How to comply with the multiple elements in the final LDT Rule.
• Why it’s best to take the first steps immediately to meet the Stage One deadline (May 6, 2025). All labs are required to implement the FDA Medical Device Quality System, something that is unfamiliar to CLIA-certified laboratories and includes adverse event reporting, for example.
• Provide a roadmap of steps forward that labs can use, including assessing whether your lab’s LDTs may be down-classified, along with identifying the most important LDTs that you want to protect.

Round out the presentations will be Valeri Palmieri, CEO of Momentum Consulting, who will discuss the following:

• Essential steps to operationalize your lab’s LDT by assessing the topline revenue it generates, the net profit it produces, and the clinical impact it delivers to physicians, patients, and payers.
• How to evaluate which LDTs you want to perform internally and which LDTs you may want to send out to reference labs.
• Elements to include in your lab’s three-year plan to comply with the LDT Rule’s requirements that become effective in the years 2025, 2026, and 2027.

You will have the opportunity to ask questions and interact with each of these three knowledgeable experts during the webinar event. You’ll get answers tailored to your lab’s unique situations.

Laboratories face unprecedented challenges with this ruling and may need to make some difficult decisions regarding their LDT menus. Despite ongoing litigation against the new rule, the FDA expects laboratories to implement the full FDA Medical Device Quality System and be in compliance by May 6, 2025—followed by other compliance requirements for 2026 and 2027. It’s one compelling reason why this webinar is a “must attend” for you and key members of your team.

Take advantage of early bird savings by registering today!