AroCell AB announced today that a dialogue has been held with the U.S. Food and Drug Administration (FDA) regarding the 510(k) submission that the company submitted on May 26, 2020. In the dialogue with the FDA, AroCell received questions regarding the 510(k) submission. AroCell intends to process the questions promptly and update the application within a few weeks.
"This type of dialogue with regulatory authorities is not uncommon when applying for 510(k). We have had a constructive dialogue with the FDA and we are now focusing on addressing the questions and updating the application in accordance with FDA recommendations," says Michael Brobjer, CEO of AroCell.