Navigating the Fda’s Laboratory-developed Tests Final Rule on May 23, 2024

When and Where:

MAY 23, 2024 | Webinar

On April 29, 2024, the US Food and Drug Administration (FDA) issued a long-awaited final rule asserting its authority to regulate laboratory-developed tests (LDTs) as medical devices. If the rule goes into effect, there will be major impacts on clinical laboratories offering LDTs.

In this webinar, we will review the LDT final rule, explore what happens next and cover critical implications for stakeholders in the diagnostics industry.

Discussion topics include:

• Overview of the final rule and differences from the proposed rule
• “Grandfathering” (i.e., continued enforcement discretion) eligibility and exemptions
• Political response including congressional impacts and election considerations
• Potential approaches to litigation
• Summary of key FDA requirements for devices

Prior to the program, you will receive an email invitation which will include the call-in number for the audio, a Zoom link and course materials. McDermott is an accredited CLE provider in CA, IL, and NY. We can issue reciprocal credit for attorneys licensed in CT, FL, and NJ. For jurisdictions not listed, attendees are provided with a Universal Certificate of Attendance which may be used to self-apply for CLE credit in their state of admission. Attendees should contact their state’s CLE Board for current rules, regulations, and guidance.

Original source can be found here.