FDA Issues Final Guidance on Metal Expandable Biliary Stents

Today, the U.S. Food and Drug Administration (FDA) issued the final guidance: Metal Expandable Biliary Stents - Premarket Notification (510(k)) Submissions. This guidance provides manufacturers with updated recommendations about testing information to include in their 510(k)) submissions for metal expandable biliary stents for certain indications. Metal expandable biliary stents within the scope of this guidance are tube-shaped devices made wholly or partially from metal that are implanted in the bile ducts, which are part of the biliary tree, and used to open or relieve malignant obstructions.

Continue Reading Facts about the final guidance  This final guidance: Replaces the "Guidance for the Content of Premarket Notifications for Metal Expandable Biliary Stents," issued on February 5, 1998. Applies only to metal expandable biliary stents indicated for palliation of malignant strictures in the biliary tree.  Questions? If you have questions about this final guidance, contact the Division of Industry and Consumer Education.