USA – FDA Finalizes Guidance on Metal Expandable Biliary Stent 510(k)s

The US Food and Drug Administration (FDA) issued final guidance on Thursday to aid sponsors of metal expandable biliary stents in preparing 510(k) submissions to seek premarket clearance.

The final document supersedes 1998 guidance on the content of 510(k) submissions to FDA for metal expandable biliary stents. It is largely similar to the draft guidance version from July 2018.

FDA’s Center for Devices and Radiological Health (CDRH) seeks to address concerns with reported use of metal expandable biliary stents for vascular applications by offering updated recommendations on the content of 510(k)s and continuing to impose limitations on substantial equivalence determinations…