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FDA Regulation of Laboratory-Developed Tests (LDTs)

Published Dec 19, 2025Updated Dec 23, 2025

The Congressional Research Service is a nonpartisan policy and legal analysis arm of the Library of Congress. CRS reports are written for members of Congress and their staff, not the public — but they’re made available openly through Congress.gov.

FDA Regulation of Laboratory-Developed Tests (LDTs) — Informed