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The US FDA recently released its final rule on the regulation of Laboratory Developed Tests (LDTs). MCRA’s IVD experts have been proactively engaged in understanding and preparing for this significant regulatory development, including analyzing the quality and clinical implications. Join us as we delve into the timeline for enforcement, the key aspects of the ruling, and how your organization can align with the new FDA requirements. Key Highlights: Summary of the final rule, areas of enforcement discretion, and staged approach to enforcement. Quality Systems requirements for LDTs. Engaging with FDA via different submission types. Developing data to support analytical and clinical validity. Join MCRA experts James Mullally, Julie Martel, and Dan Goldstein as they discuss this critical US FDA rule change for Laboratory Developed Tests. Webinar hosted by MCRA. --------------------------------------------------------- MCRA is the leading therapy focused global full-service medical device, diagnostics & biologics CRO & consulting advisory firm. MCRA is the pioneer and leader in integrating its core service offerings to bring healthcare innovation to the market globally, from conception to commercialization. Our team of industry leading talent, including former FDA reviewers, notified body decision makers, clinical subject matter experts, reimbursement veterans and payers, provides in-depth therapeutic knowledge and thorough market understanding to each project we take. MCRA's Service Offerings: Full Service Clinical Research Organization Global Regulatory Support US Regulatory Support Reimbursement, Healthcare Economics & Market Access Quality Assurance & Quality Operations Healthcare Compliance Cybersecurity Due Diligence AI & Imaging Center Talent Solutions Learn more about MCRA at www.mcra.com.