American Clinical Laboratory Association (ACLA) Opposes FDA Action
ACLA and PCR lab HealthTrackRx Sue Over Proposed Test Regulation
Effective April 29, 2024, the US Food and Drug Administration (FDA) finalized its proposal to regulate laboratory-developed tests (LDTs) as medical devices.
The American Clinical Laboratory Association (ACLA) and one of its subsidiaries, HealthTrackRx, filed a suit in opposition to the FDA ruling.
The controversy was sparked by the FDA’s intention to begin actively regulating new lab-developed tests (LDTs). LDTs are tests that are created, developed, and available in laboratories. They are often used only for very specific conditions. LDTs are typically not commercially available. Some opposing the regulation argue that the FDA lacks the necessary authority to regulate such tests.
In April, the FDA announced that around 12,000 laboratories would be obligated to submit their tests for review. Laboratories would be given a 4-year timeframe to comply with the regulations. However, tests that are already available on the market, approved by the New York test evaluation program, or developed by a health system-associated lab for patients without any alternative testing options would be exempt from these requirements.
Read more on the matter here:
And, here:
https://www.fda.gov/medical-devices/in-vitro-diagnostics/laboratory-developed-tests