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Metal Expandable Biliary Stents-Premarket Notification (510(k)) Submissions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

The Food and Drug Administration (FDA) has released a draft guidance document titled "Metal Expandable Biliary Stents--Premarket Notification (510(k)) Submissions," which outlines recommendations for 510(k) submissions for metal expandable biliary stents and their delivery systems. The document is not yet final and is available for review by industry and FDA staff.