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
Original source can be found here.