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Laboratory-Developed Test Oversight

Questions About FDA LDT Oversight?

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As CAP advocacy continues to champion for balanced laboratory-developed tests (LDT) oversight, CAP members and CAP-accredited laboratories are uniquely positioned to respond because of the collaborative efforts of CAP’s advocacy leadership, expert-developed educational resources and practical guidance gained through our accreditation checklists. The FDA's LDT final regulation introduces more stringent oversight by the FDA, affecting how these tests are validated and monitored.

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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.

  • Upcoming Webinar 3 of 6: Ready Your Laboratory for the FDA's Stage 1: Corrective Action and Removal Reporting

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

    Learn the necessary steps to comply with the FDA requirements for corrective action and removal reporting specific to laboratory developed tests. In order to help laboratories prepare for the FDA final rule, speakers will provide context relevant to laboratories and share practical solutions.

    Speakers

    • Bobbi S. Pritt, MD, FCAP, chair, Council on Scientific Affairs
    • Earle S. Collum, MD, FCAP, chair, Council on Accreditation

  • College of American Pathologists Challenges FDA LDT Regulation with Amicus Brief Filing

    The CAP filed an amicus brief on October 7 in a U.S. District Court against the Food and Drug Administration (FDA) and its regulation of laboratory-developed tests (LDTs), challenging the LDT rulemaking by the FDA, which acted arbitrarily and capriciously in violation of the Administrative Procedure Act.

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  • Webinar 2 of 6: Ready Your Laboratory for the FDA’s Stage 1: Adverse Event Reporting Requirement

    The CAP’s second webinar in the series, Understand and Prepare for the Impact of the FDA’s LDT Final Rule, discussed existing accreditation requirements and ways laboratories can comply with the FDA rules on medical device-related adverse event reporting. Accreditation experts reviewed best practices that relate to quality management and review real world scenarios. Access the presentation here.

    Watch the Recording

  • Podcast: LDT Advocacy: What You Should Know

    The Food and Drug Administration's (FDA) Laboratory Developed Test (LDT) final rule outlines new regulations for tests developed and used within a single laboratory. In this episode, A. Joe Saad, MD, CPE, FCAP discussed the newly proposed rule and the CAP’s ongoing advocacy efforts to protect pathologists and ensure patients have access to the tests they need for quality care.

    Listen to the Podcast

  • CAP Checklists and FDA LDT Final Rule

    Sept 16, 2024

    The CAP accreditation checklists contain requirements for test method validation and adverse event reporting, which are used to ensure CLIA compliance. CAP-accredited laboratories may leverage the checklists to meet the FDA requirements. The 2024 accreditation checklist edition will not contain any new changes in response to the FDA LDT final rule.

    The CAP continues to watch the FDA LDT Final Rule and timeline closely and will reevaluate any necessary updates for future checklist editions.

    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 Stage 1 Requirements table for the first stage 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.
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