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Impact of FDA’s Laboratory Developed Tests (LDTs) Ruling

Human Health In Vitro Diagnostics

Five-Stage Phaseout of Enforcement Discretion Scheduled to Begin in May 2025 

Changes are coming to how IVDs developed in laboratories are regulated! The FDA recently issued a final rule on the enforcement of IVD regulations for Laboratory Developed Tests (LDTs). This rule amends the FDA’s regulations to make explicit that IVDs are devices under the Federal Food, Drug, and Cosmetic Act (FD&C Act), including when the manufacturer of the IVD is a laboratory.  

Because IVDs offered as LDTs are more prevalent than ever, and sometimes used to diagnose life-threatening and rare illnesses, the new rule is intended to improve test accuracy and safety, while boosting transparency and consumer confidence.  

With decades of experience navigating the diagnostics regulatory environment, our team at MRIGlobal will provide you with the expertise needed to successfully transition your products to meet FDA’s expectations for compliance. This includes:  

  • Guidance through the five stages of enforcement discretion phaseout for LDTs  
  • Helping you understand the rule’s carve outs and which LDTs may continue to receive the FDA’s enforcement discretion 
  • Supporting analytical and clinical testing needed for FDA applications 

Our team at MRIGlobal serves as an extension of our client’s teams by working alongside our customers as true partners to ensure successful IVD product development, regulatory compliance, and launch. We provide customized solutions to complex and important research challenges, while remaining flexible and agile throughout the relationship, allowing us to pivot to accommodate dynamic client requirements that change with shifting market developments.

To schedule time and discuss with our team, please contact Dominie Garcia at dgarcia@mriglobal.org or Rich Masino at rmasino@mriglobal.org. 


Contact MRIGlobal for further information about our work with infectious diseases. Through a multidisciplinary approach, we provide scientific and subject matter expertise for the development of medical countermeasures research against specific threats, while expanding and accelerating the delivery of high quality clinical diagnostic products.  

To discuss how we can help your project be successful, contact us today.  


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