CDRH Finalizes Classifications on Herpes Virus IVD, Limb Tremor Stimulator

In final orders issued Tuesday, the US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) classified two new device types into class II (special controls).
 
The two devices are named “herpes virus nucleic acid-based cutaneous and mucocutaneous lesion panel” and “external upper limb tremor stimulator.”
 
Both of the new de novo classifications are intended to “enhance patients’ access to beneficial innovative devices, in part by reducing regulatory burden,” according to the final orders. This is because they allow for sponsors of these device types to use the “less-burdensome 510(k) process” compared to the data-intensive premarket approval pathway, CDRH noted.
 
Until these classifications were finalized, the new device types were subject to an automatic class III assignment by law. The de novo classification requests were submitted to CDRH in 2014 and 2017 by Quidel Corporation and Cala Health, respectively.
 
In addition to general controls, both device types have to comply with the special controls separately described in the final orders in order to fall within the new classifications.
 
For the herpes virus assay, special controls seek to mitigate the potential risks of obtaining false results and failures to correctly interpret results or operate the instrument. Special controls on the limb tremor stimulator include biocompatibility evaluation, software verification and labeling, among others. These are aimed at mitigating the potential risks of tissue damage, adverse tissue reaction, electrical shock or burn and interference with other devices.