AroCell announced today that the US Food and Drug Administration (FDA) has informed regarding the impact of the COVID-19 pandemic and the reallocations of staff is leading to a prolonged timeline for reviews of submissions. FDA at the moment expects 90 days reallocation time that will prolong AroCells 510(k) submission review.
FDA’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). And due to a large number of Emergency Use Authorization (EUA) requests that they have received for in vitro diagnostics (IVDs), and the reallocation of staff and resources are impacting the timeline for the reviews of submissions.
AroCell will receive updates regarding the anticipated timeline for the resources on the non-COVID related activities.