April 5, 2023 FDA 510(k) Aggregate Change Analysis for Special 510(k)-Cleared Devices   A Special 510(k) is intrinsically by definition a 510(k) intended to detail only a 510(k)-cleared device modification(s) rather than to detail the 510(k)-cleared aspects that haven’t been modified.  This means that the subject device described in the Special 510(k) cannot be fully characterized […]