Understanding the Impact of the FDA’s LDT Risk Classification on Your Laboratory

Part one of a six-part series.

The first webinar in our 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.

Speakers

Donald S. Karcher, MD, FCAP, President College of American Pathologists
Timothy Stenzel, MD; former Director of the FDA’s Office of In Vitro Diagnostics, current CEO of Grey Haven LLC

Additional Resources

• FDA Product Classification Database
• FDA Device Classification Information Request Guidance
• FDA Pre-Submission Request Guidance