Available online at Devices/Productsand Medical Procedures/Device Approvalsand Clearances/HDEApprovals/ucm161827 Regulatory Explainer: Making Sense of Humanitarian Use Devices. To access online sources, copy and paste the URL into your browser.

validating laboratory tests-17

Or, an existing test may not apply to a particular subpopulation from which the lab has patients, so modification of the test is required.

(Any FDA-approved commercial test that is modified in any way by a lab is considered to be an LDT and is subject to the regulations applied to all LDTs.) Examples of some LDTs include: In general, because they have not been evaluated by the FDA, LDTs should undergo a more lengthy and rigorous validation process by the individual laboratory wishing to implement the new method.

Available online at https://edu/research/clinical-laboratory-testing.

Available online at https://gov/clia/Resources/Test

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This article is periodically reviewed by the Editorial Board and may be updated as a result of the review. Regulation and Guidance, Clinical Laboratory Improvement Amendments (CLIA).