News: Metal Expandable Biliary Stent 510(k)s receives FDA finalized guidance
The sponsors of metal expandable biliary stents receive an assisting set of final guidance in preparing 510(k) submission to gather premarket experience. The present guidance ousts the 1998 guidance on the 510(k) submission. The guidance can be seen comparatively similar to the draft version from July 2018.
The major concerns by the Center for Devices and Radiological Health (CDRH), focus on the metal expandable biliary stents for vascular applications with the content of 510(k)s having updated recommendations and limited impositions on substantial equivalence determination.