What Labs Want to Know About the FDA LDTs Final Rule

The Food and Drug Administration’s (FDA) 2024 final rule on laboratory-developed tests (LDTs) has created plenty of questions for clinical lab professionals.

The rule regulates LDTs as medical devices, similar to in vitro diagnostics. As such, labs creating LDTs now must consider reporting requirements, quality system provisions, and potential FDA premarket review steps—all of which will roll out in phases from 2025 through mid-2028.

G2 Intelligence held a webinar to discuss the rule, which was attended by more than 1,000 lab professionals. This Special Analysis culls questions from the Q&A session, providing you with expert advice on a variety of LDT topics.

Some of the questions addressed in our analysis include the following:

• What does a lab do if it wants to implement a new LDT today?
• How should labs that are used to following CLIA and College of American Pathology governance think about this new FDA rule?
• What would be considered a complaint about an LDT? Does it need to be formal, or could it be a casual conversation?
• Do LDT laboratories now need to meet ISO 13485 standards since LDTs are going to be considered medical devices?

Learn more about the pathway toward LDT regulation under the FDA rule with G2 Intelligence’s special analysis.

Note: Elite-level subscribers to G2 Intelligence’s Lab Industry Advisor publication get free access to this report.