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 […]
<h1 class="entry-title">Category: 510(k) Modifications</h1>
FDA 510(k) Modifications – Inclusion of Non-Triggering Change Details
March 3, 2023 FDA 510(k) Modifications – Inclusion of Non-Triggering Change Details If multiple changes have been made to the subject device since the prior 510(k), but where only one/some of those changes trigger(s) the need for a new 510(k), and if the aggregate of changes isn’t what’s triggering the need for the new 510(k), then […]
Transferring Foreign 510(k) “Ownership” to Domestic Subsidiary
February 20, 2023 Transferring Foreign 510(k) “Ownership” to Domestic Subsidiary In a nutshell, if a foreign sponsor/owner of a U.S. FDA 510(k) clearance wants to transfer/relinquish ownership and control over to its U.S. subsidiary (or any other party), then such a business/regulatory model can have regulatory merit and, if properly configured/managed, can generally work […]