What FDA Final Rule on Laboratory Developed Tests (LDTs) - 21 CFR 809.3 Amendment and 4-Year Phaseout (May 2024) requires
FDA's Final Rule on Medical Devices - Laboratory Developed Tests (89 FR 37286, published 6 May 2024, effective 5 July 2024) amends 21 CFR Section 809.3 to make explicit that in vitro diagnostic products (IVDs) are medical devices under the Federal Food, Drug, and Cosmetic Act (FD&C Act) including when manufactured by a laboratory. The rule phases out FDA's general enforcement discretion for LDTs over five stages: Stage 1 (1 year after publication, ~May 2025) - Medical Device Reporting (MDR), correction and removal reporting, and Quality System (QS) Section 820.198 complaint files; Stage 2 (2 years, ~May 2026) - registration and listing under 21 U.S.C. 360 and 21 CFR Parts 607 and 807; labeling under 21 U.S.C. 352 and 21 CFR Parts 801 and 809 Subpart B; investigational use under 21 U.S.C. 360j(g) and 21 CFR Part 812; Stage 3 (3 years, ~May 2027) - full QS regulation under 21 CFR Part 820; Stage 4 (3.5 years, ~Nov 2027) - premarket review for high-risk IVDs offered as LDTs; Stage 5 (4 years, ~May 2028) - premarket review for moderate-risk and low-risk IVDs requiring premarket submission. Continuing enforcement discretion applies to: currently marketed IVDs offered as LDTs; HCT/P-related LDTs in blood and cell-and-gene therapy laboratories; LDTs for unmet needs; LDTs for rare diseases; public-health surveillance LDTs; forensic LDTs.
Pillar: Medical & Healthcare · Authority: Federal Register - FDA Final Rule, Medical Devices: Laboratory Developed Tests (6 May 2024) · Version: 1.0.1 · Last updated:
Primary source: https://www.federalregister.gov/documents/2024/05/06/2024-08935/medical-devices-laboratory-developed-tests
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Primary Citations — 18 traced to source
- FDA Final Rule, Medical Devices; Laboratory Developed Tests, 89 FR 37286 (6 May 2024)
- 21 CFR Section 809.3 (as amended) - IVD definition includes laboratory manufacturers
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