Zdrowie i gospodarka · 18/07/2018
Metal Expandable Biliary Stents-Premarket Notification (510(k)) Submissions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled "Metal Expandable Biliary Stents--Premarket Notification (510(k)) Submissions." This draft guidance provides recommendations for information and testing that should be included in 510(k) submissions for metal expandable biliary stents and their associated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. This draft guidance is not final nor is it in effect at this time.