Lexology July 12, 2024
On June 25, 2024, the U.S. Food and Drug Administration (FDA) released the final guidance document, Laboratory Developed Tests: Small Entity Compliance Guide (LDT Final Guidance), which aims to assist businesses of all sizes in complying with FDA regulations for in vitro diagnostic tests (IVDs), including laboratory developed tests (LDTs), as amended by the LDT Final Rule.[1]
Pursuant to the LDT Final Rule, FDA will gradually phase out its general enforcement discretion for most LDTs, which means that IVDs manufactured by laboratories will generally be required to meet all FDA device compliance requirements. In addition to setting out the timeline of the phaseout policy in a chart organized by IVD type, the LDT Final Guidance also provides a description and...
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