FDA Finalizes Guidance on Metal Expandable Biliary Stent 510(k)s
The FDA has finalized its guidelines for 510(k) submissions for metal expandable biliary stents and their delivery systems.
The guidance gives various recommendations for premarket submissions, such as information to provide for each device model proposed for marketing. This includes a labeled diagram, photograph or schematic, stent specifications including length and diameter, a description and diagram of the device’s geometry, and an explanation if any components are disposable or reusable.
The agency also provides applicants with an example table for organizing their predicate device comparisons.