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FDA Takes Action to Help Ensure the Safety and Effectiveness of Laboratory Developed Tests

Page Summary:

On 29 April, the U.S. Food and Drug Administration took action aimed at helping to ensure the safety and effectiveness of laboratory developed tests, or LDTs, which are used in a growing number of health care decisions and about which concerns have been raised for many years.

The FDA announced a final rule amending 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. Along with this amendment, the FDA issued a policy to phase out, over the course of four years, its general enforcement discretion approach for LDTs. The agency also issued targeted enforcement discretion policies for certain categories of IVDs manufactured by laboratories.

Upcoming webinar on this rule

On May 14, 2024, the FDA will host a webinar to provide an overview of the final rule and phaseout policy.

  • If you have questions about this final rule that you wish to submit for possible discussion during the webinar, please email CDRHWebinars@fda.hhs.gov.
  • All questions must be received by May 7, 2024, to be considered for the discussion. Questions will be not be taken during the live webinar.
  • Following this, the FDA intends to announce additional webinars on specific topics related to the phaseout policy and the targeted enforcement discretion policies.

 

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