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 It is largely similar to the draft guidance version from July 2018.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. CDRH states in the final guidance that such devices are not eligible for use of the Special 510(k) pathway, which was expanded last October. This was retained from the draft version, despite pushback from Cook Group in a September 2018 letter on the draft.
CDRH also did not nix the section in which it explains its concerns with vascular applications as Cook Group had requested either. Yet it clarifies a limitation on in-scope stents, metal expandable biliary stents indicated for palliation of malignant strictures in the biliary tree, which is required in the labeling information of an intended use. CDRH clarifies that “if the identical device for which clearance is being sought has also been approved for a vascular indication through a separate marketing application, this limitation may not apply.”
The final guidance revises the recommended formula for calculating foreshortening results. It adds information on using data from clinical investigations conducted outside of the US. Other tweaks to the draft relate to recommendations about testing information to include in 510(k)s.
Metal Expandable Biliary Stents - Premarket Notification (510(k)) Submissions