Lumea: Decoding The FDA-LDT Landscape Webinar

Lumea: The FDA’s recent move to treat Laboratory Developed Tests (LDTs) as medical devices has sent ripples through the industry. With the absence of a passed legislation in 2022, the FDA has taken a pivotal step, emphasizing its jurisdiction and the public health implications of several LDTs. The clock is ticking, as stakeholders have only until December 3 to voice their comments on this proposal.

Join us for an educational and illuminating webinar where FDA expert, Ralph Hall, will delve into:

• The key arguments against FDA’s oversight of LDTs
• A thorough overview of the current regulation
• Significant provisions for LDT developers
• Open issues in the debate
• The current legislative landscape
• A comparison between the proposed regulation and the last legislative draft
• Actionable steps for stakeholder engagement

⏰ Time is running out! Equip yourself with the knowledge and insights to navigate this evolving landscape. Register today for the live webinar on October 24th and ensure you are prepared to have your voice be part of this crucial conversation.

REGISTER NOW

SOURCE: Lumea