AroCell announced today that the US Food and Drug Administration (FDA) has informed that they will resume the review of AroCells 510(k) submission no later than April 15th 2021.
The Food and Drug Administration's Center for Devices and Radiological Health (CDRH) has been actively engaged in responding to the current pandemic caused by a novel coronavirus (SARS-CoV-2) and the associated disease it causes (COVID-19). Due to the on-going national emergency and the large number Emergency Use Authorization (EUA) requests, FDA have received for in vitro diagnostics (IVDs), staff and managers have been reallocated to complete the review of these requests. This has caused a delay in handling of other 510(k) submissions. The review of AroCell´s 510(k) submission will be resumed no later than April 15th 2021.