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Laboratory-Developed Test Oversight

Questions About FDA LDT Oversight?

Contact us for more information about FDA LDT oversight and phase one of the regulation.

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The FDA's Laboratory Developed Test (LDT) final rule outlines new regulations for tests developed and used within a single laboratory. Historically, LDTs have been largely regulated at the state level, with the FDA's involvement limited. The new rule introduces more stringent oversight by the FDA, affecting how these tests are validated and monitored. Since 2009, the CAP has advocated for a regulatory framework that enhances patient safety, maintains quality laboratory testing, and promotes innovation without creating significant regulatory burdens on pathologists. While the FDA made several changes, including some the CAP advocated for, there is still concern about the burden on laboratories and pathologists.

Tools and Resources

In addition to advocating on behalf of the specialty, the CAP is a resource and partner as your laboratory prepares for upcoming regulations. See the latest resources, webinars, and advocacy efforts offered by the CAP to help prepare for the five-stage phaseout policy.

  • LDT Action Alert Added to CAP’s August Recess Rally

    CAP members are asking Congress to intervene before the FDA implements its oversight of LDTs in a new action alert. Pathologists can easily use the CAP’s PathNET Action Center and take action.

    We need Congress to stop the FDA Final Rule

    Engage and Advocate

  • WEBINAR: Understand and Prepare for the Impact of the FDA’s LDT Final Rule

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

    The first webinar in our six-part series, Understand and Prepare for the Impact of the FDA’s LDT Final Rule Webinar 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.

    Register Now

  • LDT thoughts offer nuance, and advice

    In part two of a two-part series, the August CAP Today cover story provides a nuanced perspective on the FDA's new final rule regarding LDTs.

    "For labs, says Dr. Cardona, “It’s not just the fact that we’ve got something new as far as regulation to consider. It’s a whole new language. Laboratories historically have not had to submit for IVD 510(k) clearance. That’s not what laboratory medicine is focused on.”

    Diana Cardona, MD, MBA, an associate professor of pathology and the associate director of clinical laboratories at Duke Health, as well as a governor on the CAP Board of Governors.

    Read the article

For Laboratories

  • Stage One Update

    Jun. 20, 2024

    Pathologists and laboratories will consider several factors to determine if a test must meet FDA regulatory requirements for LDTs. See the FDA Oversight of LDTs Phase 1 Requirements table for the first stage or phase of requirements beginning May 6, 2025.

    Medical device reporting: Laboratories must report certain device-related adverse events and product problems to the FDA.

    • FDA Resource: Mandatory Reporting Requirements: Manufacturers, Importers and Device User Facilities

    Correction and Removal: Required to make a report to the FDA of any correction or removal of a medical device(s) if the correction or removal was initiated to reduce a risk to health posed by the device or to remedy a violation of the act caused by the device which may present a risk to health.

    • FDA Resource: Recalls, Corrections and Removals (Devices)

    Quality system for complaints requirements:

    • Maintain complaint files.
    • Designate a formal complaint handling unit.
    • Establish and maintain procedures for receiving, reviewing, and evaluating complaints.

FDA Resources

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