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Understand and Prepare for the Impact of the FDA’s LDT Final Rule Webinar Series

Sep 18, 2024 12:00 PM - 1:00 PM CT

A CAP six-part webinar series

On May 6, the FDA released its long-awaited regulation on the oversight of laboratory-developed tests (LDTs). Laboratories and pathologists—many having never worked with the FDA—now have more questions than answers as they face implementation of the LDT regulation’s first phase in 2025.

While the CAP and its members oppose the regulation and are actively working to stop the FDA, we are committed to helping our pathology and laboratory community understand and prepare their operations with a series of six bite-size learnings on the new LDT oversight rules.

Whether you attend live or watch the on-demand recording at a time more convenient for you, register today and get the answers you need.

  • Understanding the Impact of the FDA’s LDT Risk Classification on Your Laboratory

    Sept. 18, 2024
    Noon-1 p.m. CT

    The first webinar in our series will help laboratories understand FDA risk classification systems. We will discuss differences in classifications used by the FDA and CLIA, requirements under the FDA risk categories, and what activities are included in the FDA’s general and special controls. Our experts will also discuss examples of common tests and how the FDA requirements will apply to them.

    Speaker
    Donald S. Karcher, MD, FCAP, President College of American Pathologists

    Register Here

  • Ready Your Laboratory for the FDA’s Stage 1: Adverse Event Reporting Requirement

    Nov. 7, 2024
    Noon-1 p.m. CT

    Details forthcoming

    Register Here

  • Ready Your Laboratory for the FDA’s Stage 1: Corrective Action and Removal Reporting

    Jan. 9, 2025
    Noon-1 p.m. CT

    Details forthcoming

    Register Here

  • Ready Your Laboratory for the FDA’s Stage 1: Rules for Quality System Complaint Processes

    Mar. 20, 2025
    Noon-1 p.m. CT

    Details forthcoming

    Register Here

  • How Enforcement Discretion Categories & Modification Rules Apply to Your LDTs

    May 8, 2025
    Noon-1 p.m. CT

    Details forthcoming

    Register Here

  • Navigating the FDA’s LDT Oversight Requirements During a Public Health Emergency

    Jul. 10, 2025
    Noon-1 p.m. CT

    Details forthcoming

    Register Here

Learn more about the FDA Oversight of LDTs and the CAP's Advocacy Efforts

Laboratory-Developed Test Oversight
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