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- Key Questions on FDA LDT Oversight Answered by a Former FDA Director: CAP Webinar
Did you miss the “Understanding the Impact of the FDA’s LDT Risk Classification on Your Laboratory” webinar on September 18? Watch the recording on-demand featuring CAP President Donald Karcher, MD, FCAP and Timothy Stenzel, MD, PhD, (Retired) Director, Office of In Vitro Diagnostics at the FDA as they 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.
Top questions from webinar participants answered during the Q&A session included:
- How does the FDA risk classification system apply to immunohistochemistry testing?
- What if a test is classified in two different risk categories? For example, FISH testing can be both low-risk and high-risk.
- Is there a difference between tests currently under forensic use-only versus for employment and insurance testing purposes? Things like drugs for abuse testing and/or federally mandated drug tests?
- What exactly is required for stage 1 of the FDA LDT oversight regulation?
They also covered examples for how the FDA classification system applies to:
- Lactic acid tests.
- BCR/Abl1 monitoring tests.
- High throughput sequencing based tumor profiling tests.
- Chromogenic in situ hybridization, nucleic acid amplification, HER2/Neu gene tests
Over 3,000 people registered for our first webinar with over 150 questions submitted! Don’t miss the next in our series titled: “Ready Your Laboratory for the FDA’s Stage 1: Adverse Event Reporting Requirement” on November 7, 2024, Noon–1:00 PM CT. Register now!