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On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

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  6. Laboratory Developed Tests: FAQs
  1. Laboratory Developed Tests

Laboratory Developed Tests: FAQs

On these pages you’ll find answers to the most common questions FDA has received through ldtfinalrule@fda.hhs.gov related to laboratory developed tests (LDTs). To ensure we are answering generally applicable questions in a manner that is transparent, we intend to respond to questions submitted to the mailbox, as appropriate, in a public manner, such as in webinars, guidances, this FAQ page, and other resources over the course of the phaseout period. FDA intends to update this FAQ page periodically. If you cannot find the answer you’re looking for, please contact FDA through the mailbox at ldtfinalrule@fda.hhs.gov.



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