AgileMD, Inc. – FDA 483, May 17, 2024

This document is a response from AgileMD, Inc., submitted by their regulatory counsel Hogan Lovells US LLP, to an FDA Additional Information Request concerning their 510(k) submission (K233253/S001) for the eCARTv5 Clinical Deterioration Suite. The submission addresses FDA's outstanding concerns to support clearance of the eCART device, which is a software product for automated risk stratification and early warning of patient deterioration.