How the Proposed LDT Regulations Could Affect You

Presented by Presented by Rodney Forsman, CLMA Past President and Assistant Professor Emeritus of Lab Medicine and Pathology, College of Medicine, Mayo Clinic,and Dr. James Nichols, Professor of Pathology, Microbiology, and Immunology, Medical Director of Clinical Chemistry, and Associate Medical Director for Clinical Operations at Vanderbilt University School of Medicine.

Rodney and James discuss the proposed FDA regulation of Laboratory Developed Tests (LDTs) and how these changes will impact your laboratory operations. Even if you don’t use LDTs, your reference labs might, so you could still be affected.

Learning Objectives

  • Define Laboratory Developed Tests
  • Describe proposed changes to the FDA regulations
  • Identify how LDT regulations could impact your institution

Continuing Education
1.0 Continuing Education Unit

Body of Knowledge Learning Domains

  • Governance and Organizational Dynamics

Content Level

  • Essential


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