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- Understand and Prepare for the Impact of the FDA’s LDT Final Rule Webinar Series
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.
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Webinar 4 of 6 - Ready Your Laboratory for the FDA's Stage 1: Quality System for Complaint Requirements
Mar 20, 2025
Noon-1 pm CTGain a better understanding on the necessary steps to comply with the FDA’s Stage 1 rule for quality system complaints. This webinar will guide you through the new requirements, focusing on practical solutions tailored for laboratories. Our expert speakers will provide relevant context and actionable insights to help your lab implement effective complaint handling and reporting mechanisms.
Speakers
- Bobbi S. Pritt, MD, FCAP, chair, Council on Scientific Affairs
- Earle S. Collum, MD, FCAP, chair, Council on Accreditation
- Deeona R. Gaskin, J.D., MPH, partner, Sidley Austin
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How Enforcement Discretion Categories & Modification Rules Apply to Your LDTs
May 8, 2025
Noon-1 p.m. CTDetails forthcoming
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Navigating the FDA’s LDT Oversight Requirements During a Public Health Emergency
Jul. 10, 2025
Noon-1 p.m. CTDetails forthcoming
Previous Webinars
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Ready Your Laboratory for the FDA's Stage 1: Quality System for Complaint Requirements
The third webinar in this series discussed the 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 provided context relevant to laboratories and shared practical solutions.
Additional Resources
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Ready Your Laboratory for the FDA’s Stage 1: Adverse Event Reporting Requirement
The second webinar in this series 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.
Additional Resources
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Understanding the Impact of the FDA’s LDT Risk Classification on Your Laboratory
The first webinar in our series helped laboratories understand FDA risk classification systems. We discussed 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 also discussed examples of common tests and how the FDA requirements will apply to them.
Additional Resources