CDRH Classifies Respiratory Infection IVD, System for Neurological and Psychiatric Disorders

Regulatory NewsRegulatory News | 14 March 2019 |  By 

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.”

The final orders codified medical device regulations and established the special controls both new device types would need to comply with in order to fall within the new class II classifications and go through the less-burdensome 510(k) clearance pathway, rather than the more data-intensive premarket approval application pathway for class III devices. The automatic class III occurs by operation of law, regardless of any FDA action or the new device’s level of risk. Reclassifications address this automatic class III to increase access partly via reduced burden.

Following the review of Curetis GmbH’s de novo request, the final order identified three potential risks that this device type poses. The risks relate to identifying pathogenic microorganisms by the device, as well as interpreting the test results and correctly operating the instrument. Conditions on labeling, including several limiting statements, and design verification and validation are some of the new mitigation measures.

“The device is intended to aid in the diagnosis of respiratory infection in conjunction with clinical signs and symptoms and other laboratory findings,” CDRH clarified. “These devices do not provide confirmation of antibiotic susceptibility since mechanisms of resistance may exist other than those detected by the device.”

Based on the review of Brainsway’s request, the identified risks include seizure, thermal injury, hearing loss, adverse effects due to treatment, adverse tissue reaction, electric shock and device failure due to interference with other devices. Mitigation measures relate to nonclinical performance testing, labeling, biocompatibility evaluation, electrical safety testing and others listed in the new device’s final order.


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