What Laboratory Developed Tests (LDTs) - FDA Oversight & Global Alignment (2026) requires
The FDA’s final rule on Laboratory Developed Tests brings most LDTs under medical device regulation with phased enforcement. Requirements include registration, listing, adverse event reporting, quality systems (QMSR), premarket review for higher-risk tests, and labeling. Laboratories must comply with both CLIA and FDA obligations, with significant impact on precision medicine and companion diagnostics.
Pillar: Medical & Healthcare · Authority: U.S. Food and Drug Administration (FDA) · Version: 1.0.0 · Last updated:
Primary source: https://www.ecfr.gov/current/title-21/chapter-I/part-820
SHA-256 integrity: 713ea4137d89d6257968831997c639ee0a4984f81aad55eb24b48a0a673c2dcf
Primary Citations — 3 traced to source
- FDA Final Rule on Laboratory Developed Tests (May 2024, phased enforcement through 2026-2028)
- 21 CFR Part 820 QMSR applicability to LDTs
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