FDA issues draft guidance on Premarket Notification (510(k)) Submissions for Metal Expandable Biliary Stents

FDA issues draft guidance on Premarket Notification (510(k)) Submissions for Metal Expandable Biliary Stents

Today, the U.S. Food and Drug Administration (FDA) issued the draft guidance “Metal Expandable Biliary Stents - Premarket Notification (510(k)) Submissions.” This guidance, when final, will provide updated recommendations for manufacturers about the information and testing that should be included in 510(k) submissions for metal expandable biliary stents and their associated delivery systems intended to provide luminal patency of malignant strictures in the biliary tree. Metal expandable biliary stents are tube-shaped devices made wholly or partially from metal that are implanted in the bile duct system, also known as the biliary tree, and used to open or relieve malignant obstructions. This draft guidance applies to metal expandable biliary stents indicated for palliation of malignant strictures (relief from narrowing of the bile duct due to a tumor) in the biliary tree (structures responsible for emptying bile into the small intestine). It does not apply to biliary stents indicated to treat benign strictures (not caused by cancer) or stents intended to be used in the vasculature, tracheal/bronchial tubes, or other gastrointestinal anatomy. Once finalized, this guidance will replace the “Guidance for the Content of Premarket Notifications for Metal Expandable Biliary Stents,” issued on February 5, 1998. The updated recommendations are intended to reflect current review practices. Comments to this draft guidance should be submitted either electronically or in writing within 60 days of publication in the Federal Register. Comments can be submitted to http://www.regulations.govunder Docket No. FDA-2018-D-1771. If you have any questions, please contact the Division of Industry and Consumer Education (DICE) in the Center for Devices and Radiological Health (CDRH) at 1-800-638-2014, 301-796-7100 ordice@fda.hhs.gov. Food and Drug Administration Center for Devices and Radiological Health