The FDA's Final LDTs Rule Is Out—Now What?
The Mayo Clinic’s Shannon Bennett shares his initial thoughts on the rule and what clinical labs will need to do
Rachel Muenz is the managing editor of G2 Intelligence and was previously senior digital content editor at Lab Manager, a publication dedicated to teaching lab professionals the management skills they need to run their laboratories as effectively as possible. She has more than 10 years of experience as a writer, editor, and curator of both print and digital content, with the majority focused on laboratory topics. Rachel holds an honors bachelor of arts degree in English from the University of Toronto and a diploma in journalism from Centennial College. Rachel regularly contributes news and insights to Today's Clinical Lab.
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Shannon Bennett, director of regulatory affairs, Department of Laboratory Medicine and Pathology, Mayo Clinic
Officially released on May 6, the FDA’s final rule on the regulation of laboratory-developed tests (LDTs) contains some surprises from the version proposed in September 2023.
Shannon Bennett, director of regulatory affairs in the Department of Laboratory Medicine and Pathology at Mayo Clinic, shares his initial thoughts on the rule and what labs will need to do now.
Q: What surprised you most about the FDA's final rule on lab-developed tests and why?
A: The proposed rule broadly rescinded the FDA’s general enforcement discretion over LDT regulation. The final rule did as well, but also introduced several categories of continued, targeted enforcement discretion. That was a significant change.
Q: Which aspects of the rule do you think medical labs will find most challenging and why?
A: Diagnostic laboratories that do not qualify for one of the targeted enforcement discretion categories will have the hardest time, in my opinion. The medical device framework is rigid and does not account for the dynamic nature of laboratory diagnostics, which rely on the expertise of laboratory professionals and are iteratively improved to reflect the latest advances in laboratory and clinical science.
Cancer diagnostics provide a good example—physicians frequently turn to laboratory-developed testing services, even where FDA-approved tests are available, because these services include the latest scientific understanding, whereas FDA-regulated tests can fall behind.
Q: What should labs do now to address the rule?
A: It is imperative that laboratories educate themselves on the final rule as quickly as possible, as the variety of enforcement discretion categories and quality system requirements can be complex. Laboratories that want to offer any LDTs will need to (at least) meet the first-year requirements, so those labs need to be prepared to do so.
Join us on May 30 for a live webinar, “What You Need to Know about the FDA's New LDT Regulations,” with Shannon Bennett and fellow regulatory expert Julie Ballard of Carrot Clinical to learn more about the FDA’s new LDTs rule and what future steps labs needs to take.
