FDA Final Rule Changes for Medical Devices and LDTs

The final rule related to medical devices and LDTs (Laboratory Developed Tests) was finalized in April 2024 by the FDA. This final rule amends the regulations making explicit that IVDS are devices under the Federal food, Drug, and Cosmetic Act, including when the manufacture of the IVD is a laboratory. The IVDs offered as LDTs will follow a four-year phaseout process that changes the applicability of certain reporting and QMS requirements, registration and labeling requirements, complaint files, and premarket review requirements for certain IVDs. This phaseout process is broken down into five stages.

Stage 1 of this phaseout related to the final rule begins May 6, 2025.

To access details related to the various Stages and details related to overall rule change go to: Click here.

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MedEnvoy can assist you in determining how this rule change impacts your current IVD portfolio and determine applicability to your QMS and current process and practices concerning IVDs. Contact us if you need assistance or have any question about navigating the changes brought by the FDA final rule relating to medical devices and LDTs.

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