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FDA Revises Guidance on Biliary Stent 510(k)s

July 19, 2018

The FDA released draft guidance that makes revisions to its 1998 guidance on metal expandable biliary stents, updating its recommendations for information to include in 510(k) submissions.

The guidance applies to biliary stents that are indicated for palliation of malignant 109 strictures in the biliary tree. It does not cover biliary stents indicated to treat benign strictures or stents intended to be used in the tracheal or bronchial tubes, vasculature or gastrointestinal anatomy.

The agency said applicants should determine the biocompatibility of all parts in the biliary stent and stent delivery system that touch the patient in order to avoid harmful biological responses.

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