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- Register for Tomorrow’s Webinar! Understanding the Impact of the FDA’s LDT Risk Classification on Your Laboratory Featuring Former FDA Director
The CAP is launching a six-part webinar series to help the pathology and laboratory community understand and prepare for the Food and Drug Administration (FDA) oversight rules for laboratory-developed tests. The first webinar in our series starts tomorrow, September 18, Noon-1 PM CT, will help laboratories understand FDA risk classification systems.
CAP President Donald Karcher, MD, FCAP will moderate the program and pathologist Timothy Stenzel, MD, PhD, (Retired) Director, Office of In Vitro Diagnostics at the FDA will discuss differences in classifications used by the FDA and CLIA, requirements under the FDA risk categories, and what activities the FDA includes in its general and special controls. Our experts will also discuss examples of common tests and how the FDA requirements will apply to them. There will be a Q&A session at the end.
Whether you attend live or watch the on-demand recording at a time more convenient for you, register today for the first event in the series and save the dates for the upcoming webinars through July 2025.
Future webinar topics:
- November 7, 2024, Noon–1:00 PM CT, Ready Your Laboratory for the FDA’s Stage 1: Adverse Event Reporting Requirement
- January 9, 2025, Noon–1:00 PM CT, Ready Your Laboratory for the FDA’s Stage 1: Corrective Action and Removal Reporting
- March 20, 2025, Noon–1:00 PM CT, Ready Your Laboratory for the FDA’s Stage 1: Rules for Quality System Complaint Processes
- May 8, 2025, Noon–1:00 PM CT, How Enforcement Discretion Categories & Modification Rules Apply to Your LDTs
- July 10, 2025, Noon–1:00 PM CT, Navigating the FDA’s LDT Oversight Requirements During a Public Health Emergency
