FDA WARNING_LETTER - Uscom Kft - January 30, 2025

Uscom Europe, located in Budapest, Hungary, was inspected by the FDA from January 27 to January 30, 2025. The inspection revealed significant regulatory violations concerning the company"s spirometer devices, particularly the SpiroSonic AIR. This device is considered adulterated under section 501(f)(1)(B) of the Federal Food, Drug, and Cosmetic Act because it lacks an approved premarket approval (PMA) application or an investigational device exemption. Additionally, it is misbranded under section 502(o) for failing to notify the FDA of its commercial distribution intent, as required under section 510(k).

The SpiroSonic AIR"s design and intended use changes, including multi-patient use flow tubes, Bluetooth technology, and home setting applications, significantly affect its safety and effectiveness compared to the previously cleared SpiroThor device. Despite submitting a premarket notification (K220982) in April 2022, Uscom Europe did not adequately respond to the FDA"s request for additional information, leading to the withdrawal of their submission in February 2023. Consequently, the SpiroSonic AIR lacks 510(k) clearance and cannot be legally marketed.

The inspection also identified Quality System Regulation (QSR) violations under section 501(h), specifically the failure to establish and maintain adequate design validation procedures. The SpiroSonic Mobile Software V1.16, intended for use with SpiroSonic AIR, was not properly validated. The FDA requires Uscom Europe to cease activities that result in device misbranding or adulteration and to address the noted violations to comply with regulatory standards.