Federal Register #Docket No. FDA-2026-N-3900

FDA Classifies Two Medical Devices and FAA Establishes Airspace at Gallatin County Airport

This summary covers the FDA's classification of two medical devices and the FAA's establishment of airspace at a federal airport: - Government Buyers: - Food and Drug Administration (FDA), Center for Devices and Radiological Health - Federal Aviation Administration (FAA), Operations Support Group, Central Service Center - Medical Devices Classified by FDA: - Setmelanotide Eligibility Gene Variant Detection System - Qualitative in vitro diagnostic device for detecting germline gene variants to identify obesity patients eligible for setmelanotide treatment - Classified as Class II with special controls (design verification, validation, labeling) - Part Number: 862.1164 - Alzheimer's Disease Pathology Assessment Test - Device for assessing Alzheimer's disease pathology - Classified as Class II with special controls - OEMs and Vendors: - No specific manufacturers or vendors are named in the classification orders - Unique or Notable Requirements: - Devices must meet special controls for safety and effectiveness, including design verification, validation, and labeling to mitigate risks of incorrect test performance and interpretation - Classification aims to reduce regulatory burdens and facilitate patient access to innovative devices - FAA Airspace Action: - Establishment of Class E airspace at Gallatin County Airport, Sparta, KY, to support IFR operations - Key Locations: - FDA Center for Devices and Radiological Health, Silver Spring, MD - FAA Central Service Center, Fort Worth, TX - Gallatin County Airport, Sparta, KY

Description

The Food and Drug Administration (FDA) is classifying the setmelanotide eligibility gene variant detection system into class II with special controls. This device is a qualitative in vitro diagnostic intended to detect germline variants within genes from human specimens to identify patients with obesity who may benefit from treatment with setmelanotide. The classification aims to provide reasonable assurance of safety and effectiveness while enhancing patient access to innovative devices by reducing regulatory burdens. The classification was effective April 22, 2026, and includes specific design verification, validation, and labeling requirements to mitigate risks associated with incorrect test performance and interpretation.

View original listing