Complizen Learn

In 510(k) , substantial equivalence (SE)  means your device has the same intended use  as a predicate  and either the same tech...

An RTA hold  happens when a 510(k)  fails FDA’s acceptance review  and is not accepted  for substantive review; you then have 180 days...

eSTAR  is FDA’s interactive PDF template that structures medical-device submissions in the same layout reviewers use, with built-in...

An FDA Pre-Submission (Q-Sub)  is a voluntary  way to get FDA feedback—by written response and/or a meeting—before or during an IDE,...

An HDE  is a marketing application for a Humanitarian Use Device (HUD) —a device intended to treat/diagnose a condition that affects or...

An Investigational Device Exemption (IDE)  lets an unapproved  or new-use  device be used in a U.S. clinical study to collect...