05. 07. 2024

FDA Releases Long Awaited Lab Developed Test Final Rule

By ERI Group

This week, the FDA released the long anticipated Final Rule for Lab Developed Tests (LDTs).  #LDTs are In Vitro Diagnostic Tests (IVDs) that are developed, manufactured and performed within a single lab.  Since 1976 and the Medical Device Amendments to the Food, Drug, and Cosmetic Act, FDA has applied enforcement discretion to these types of tests as they were generally low risk, small volume, and used for the specialized needs of the local patient population.  LDTs today are considered by FDA to have a much higher public health risk as they are used more widely, used for larger and more diverse patient populations, and sometimes involve large laboratories which accept patient samples from across the country.  Today’s LDTs also often rely on complex high-tech instrumentation and software which commonly do not undergo the extensive validation that regulated IVD manufacturers are required to perform.


Due to the above, the FDA final rule will require most future LDTs to comply to FDA medical device regulations including adverse event reporting, recalls, premarket review (such as 510k, De Novo applications, and PMA), as well as compliance with the Quality System Regulation.  The final rule plans for a transition period over 4 years based on the risk level of the diagnostic test.  A significant change from the proposed rule is that the final rule still maintains enforcement discretion regarding premarket review and most QMS requirements for LDTs that were being marketed prior to institution of the Final Rule.  This effectively “grandfathers” current LDTs from the bulk of the Final Rule, however FDA states, as with all enforcement discretions, that they can remove or amend the aspects of the enforcement discretion at any time if it comes clear that there are public health risks associated with the current policy.


ERI’s Regulatory and Quality groups are waiting to help your clinical lab navigate this transition from LDT to IVD regulation in the most efficient and least disruptive way.  We have over 30 years of experience in IVD/medical device submission and compliance activities with a focus on novel technology.

Let ERI give you piece of mind during this important transition phase.

Connect with us at ragroup@erigroup.com or learn more: FDA Takes Action Aimed at Helping to Ensure the Safety and Effectiveness of Laboratory Developed Tests | FDA