The in vitro diagnostic (IVD) device for antibiotic susceptibility testing in respiratory samples and the transcranial magnetic stimulation system for neurological and psychiatric disorders were classified as class II medical devices, following the release of US Food and Drug Administration (FDA) final orders.
FDA’s Center for Devices and Radiological Health (CDRH) finalized the class II assignments on the IVD and the system that have been applicable since April and August 2018, respectively, in the two final orders separately issued Wednesday. The orders aim to aid sponsors of both device types in providing general assurances of safety and effectiveness with new special controls as identified by the final orders.
The IVD classification comes as a result of the de novo classification requests submitted by Curetis GmbH in 2017 to classify its Unyvero LRT Application. The neurological device classification is based on the Brainsway 2017 de novo request for its Brainsway Deep Transcranial Magnetic Stimulation System.
The generic IVD type was named “device to detect and identify microorganisms and associated resistance marker nucleic acids directly in respiratory specimens.” The generic name of the system is “transcranial magnetic stimulation system for neurological and psychiatric disorders and conditions.”…