Biovica, active in cancer diagnostics, today announced that the company’s expected timeline for its updated 510(k)-application to the US Food and Drug Administration (FDA) has been prolonged due to delay in response from FDA.
As Biovica is still waiting for required feedback from the FDA the company has not been able to submit its updated application yet. This means that the company most likely will not receive an answer from the FDA before the end of September, as previously communicated.
After submitting the response to the FDA, the expected outcome is either approval (clearance) or a request to submit more information.
“It is of course unfortunate that the FDA process is delayed. It is caused by the pandemic situation and unfortunately out of our control. We are ready to submit updates to the application but need to have patience and understanding about how the pandemic situation has affected processing times at the FDA. Thankfully, this is a short-term obstacle that will be overcome in due time,” said Anders Rylander.