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Webinar

Navigating the FDA’s LDT Final Rule: Legal Challenges and Upcoming Compliance Deadlines Facing the Laboratory Industry

Join Today's Clinical Lab and Charles C. Dunham IV and Nick Diamond in Navigating the FDA’s LDT Final Rule

Webinar Live Date: March 5 @1:00pm ET


Clinical lab managers and compliance officers find themselves in a critical period of change related to the Food and Drug Administration’s (FDA) regulation of laboratory-developed tests (LDTs). The first phase-out compliance deadline (May 6, 2025) is only months away for labs that produce LDTs. Yet before then, keen observers are watching federal action in U.S. District Court in the Eastern District of Texas, which is expected to decide two consolidated lawsuits challenging the FDA’s authority to regulate LDTs.  To help lab managers and compliance officers prepare for FDA compliance, join prominent healthcare attorneys Charles Dunham and Nick Diamond for this timely, free webinar. During this program, attendees will:

  • Learn more about the FDA’s history of LDT oversight with enforcement discretion and targeted congressional legislation.
  • Understand the legal arguments against the FDA’s authority and what the possible outcomes will mean for clinical labs.
  • Explore what guidance the FDA has provided to the market about Phase I compliance of the LDT rule in 2025.
  • Walk away with operational steps clinical labs can take in an uncertain regulatory environment.
Charles C. Dunham IV

Charles C. Dunham IV

Shareholder

Greenberg Traurig, LLP

Charles Dunham is a corporate healthcare attorney at the international law firm of Greenberg Traurig, LLP.  He advises an array of healthcare providers, suppliers, and other health-related entities, with a focus on laboratories, telemedicine, medical devices, and digital health. He provides legal counsel in corporate, regulatory, transactional, reimbursement, privacy, and compliance matters. He also represents clients in payor audits and investigations, white-collar civil and criminal defense, and commercial litigation.



Nick Diamond

Nick Diamond

Shareholder

Greenberg Traurig, LLP

Nick Diamond is a trusted counsel to companies and investors across the life sciences, medical device, and technology sectors in the United States and abroad. His regulatory practice concentrates on FDA and spans research, commercialization, post-market compliance, and enforcement, particularly involving drugs and devices. This focus includes counseling clinical laboratories, research institutions, and CROs on clinical research matters.


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