FDA Announces Final Rule for Laboratory Developed Tests (LDTs)

SciFocus/May 2024 -- The FDA has issued a final rule for Laboratory Developed Tests (LDTs), aiming to enhance safety and effectiveness in diagnostic testing. Here are the key highlights:

• The rule explicitly states that in vitro diagnostic products (IVDs), including those manufactured by laboratories, are devices under the FD&C Act.
• A phaseout of the FDA's general enforcement discretion approach for LDTs will occur over four years, along with targeted enforcement discretion policies for specific categories of IVDs.
• On May 14, 2024, the FDA will host a webinar to discuss the final rule and phaseout policy. Questions for the webinar can be submitted by May 7, 2024.
• LDTs are IVDs intended for clinical use, designed, manufactured, and used within a single certified laboratory.
• The FDA's increased oversight aims to address evolving risks associated with modern LDTs, ensuring patient safety and effective healthcare decisions.

For more details and webinar registration, visit the FDA's website. #LabTests #FDARegulations #HealthcareSafety

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