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- Register Today for Upcoming LDT Webinar! Ready Your Laboratory for the FDA’s Stage 1: Adverse Event Reporting Requirement
Under the Food and Drug Administration (FDA) regulation, laboratories with laboratory-developed tests (LDTs) must have a process in place for adverse event reporting starting May 6, 2025. The CAP’s second webinar in our series will discuss existing accreditation requirements and ways laboratories can comply with the FDA rules on medical device-related adverse event reporting. Accreditation experts will review best practices that relate to quality management and review real world scenarios. Join us on Nov. 7, Noon-1 PM CT to learn more!
Speakers
- Bobbi S. Pritt, MD, FCAP, chair, Council on Scientific Affairs
- Earle S. Collum, MD, FCAP, vice chair, Council on Accreditation