The scope of the FDA’s authority over laboratory-developed tests (LDT) has long been a source of controversy. Now, makers of LDT will have to adjust to the brand-new final rule affirming LDT are in vitro diagnostic products that will be regulated by the FDA as medical devices. This ruling will likely trigger an avalanche of litigation from various stakeholders, as the FDA also intends to phase out the enforcement discretion it has historically applied to most LDT.

In this webinar, presented by Ropes & Gray partner Joshua Oyster, attendees will gain a clear understanding of the immediate impact of the new LDT final rule, the many changes that will accompany it, and its long-range implications for the industry.

Webinar Takeaways:

  • Examine the various intricacies of the LDT final rule.
  • Survey the scope and timeline for the FDA’s phaseout of enforcement discretion for LDT.
  • Dissect the way the FDA responded to industry comments on the proposed rule.
  • Contemplate the legislative solutions being considered by Congress.
  • Explore the potential avenues for litigation challenging the final rule.

Join this prominent regulatory expert for instruction on how to optimize your LDT applications, limit litigation and ensure approvals. With so much unclear in light of the final rule, this webinar explains it all.

Who Will Benefit:

  • Pharma companies developing products that rely on LDTs
  • Clinical laboratories offering LDTs
  • Diagnostics companies
  • Legal, compliance and regulatory affairs staffs
  • Quality staff
  • Business Development staff