FDA Oversight of Laboratory-Developed Tests — The Impact of the Final Rule

It’s the most significant regulatory change for laboratory-developed tests (LDT) in decades!

Find out what the FDA’s final rule asserting the agency’s authority to regulate LDTs and phasing out of enforcement discretion means for your business.

This management report — based on a webinar presentation by Ropes & Gray partner Joshua Oyster — provides a detailed analysis of the impact of the LDT final rule and its five-stage implementation by the FDA over four years.

Report Takeaways:

• Grasp the intricacies of the LDT final rule.
• Understand the scope and timeline for the FDA’s phaseout of enforcement discretion for LDTs.
• Take in how the FDA responded to industry comments on the proposed rule.
• Hear about the legislative solutions being considered by Congress.
• Explore the potential avenues for litigation challenging the final rule.

Learn from a prominent regulatory expert how to optimize your LDT applications to help secure a 510k clearance or premarket approval.

Order your copy today!

About the Contributor

Joshua Oyster, a partner at the law firm Ropes & Gray, is a nationally recognized FDA regulatory expert who represents medical product manufacturers and other life sciences companies and investors. He has extensive experience advising on a range of enforcement, compliance, and transactional matters, including the FDA’s oversight of laboratory-developed tests.

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