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PubMed

US Food and Drug Administration and Off-Label Use of Metal Expandable Biliary Stents within the Peripheral Vasculature-Update.

PMID: 32094048 ·

A, p, r, i, l, , K, , M, a, r, r, o, n, e, ;, , L, a, u, r, a, , G, o, t, t, s, c, h, a, l, k, ;, , A, l, l, e, n, , L, , C, h, e, n

RevistaJournal of vascular and interventional radiology : JVIR
Año
PMID32094048

Resumen

In the past, some medical device manufacturers were obtaining marketing clearance for metallic stents indicated for biliary use; however, these devices were being promoted and used in the peripheral vasculature, creating a patient safety problem. The US Food and Drug Administration (FDA) acted in 2006-2008 to help decrease off-label use of metal expandable biliary stents. This communication describes the early and continued efforts of the FDA to address safety concerns relating to off-label use

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