FDA finalized classification of the Alzheimer's disease pathology assessment test as Class II (special controls), codifying the device type under 21 CFR 866.5840. The classification was applicable May 4, 2022, following De Novo review of Fujirebio Diagnostics' Lumipulse G β-Amyloid Ratio (1-42/1-40) device. Special controls identified in the order will apply to all devices of this generic type.
The FAA has issued a final rule establishing Class E airspace at Sparta, KY (Gallatin County Airport). The new airspace extends upward from 700 feet above the surface within a 6.5-mile radius of the airport to support new instrument procedures and IFR operations. The rule takes effect at 0901 UTC on July 9, 2026.