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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 ...