U.S. Food and Drug Administration and off-label use of expandable metal biliary stents within the peripheral vasculature.
Expandable metal stents are used to maintain the patency of compromised ducts, lumens, and vessels. As medical devices, there products are regulated by the Center for Devices and Radiological Health of the U.S. Food and Drug Administration (FDA). During the past several years, the FDA has become aware of the increasing prevalence of off-label use of expandable metal stents cleared for biliary use within the peripheral vasculature. The authors provide an overview of how the FDA regulates medical devices and expandable stents and summarize safety issues reported to the Agency with regard to the off-label use of these biliary stents.
Yustein
Aron S
AS
Center for Devices and Radiological Health, U.S. Food and Drug Administration, 9200 Corporate Boulevard, Rockville, MD 20850, USA. aron.yustein@fda.hhs.gov
Schultz
Daniel
D
Neuland
Carolyn
C
Buckles
David S
DS
Nipper
Joshua C
JC
Stephenson
Rebecca A
RA
Gonzalez
Gema
G
D001662:Biliary Tract Surgical Procedures / Q000009:adverse effects / Q000295:instrumentation* / Q000331:legislation & jurisprudence; D003257:Consumer Product Safety; D018795:Device Approval / Q000331:legislation & jurisprudence; D033161:Government Regulation; D019983:Guideline Adherence; D006801:Humans; D008670:Metals; D017410:Practice Guidelines as Topic; D011358:Product Surveillance, Postmarketing; D011474:Prosthesis Design; D011475:Prosthesis Failure; D015607:Stents; D014481:United States; D014656:Vascular Surgical Procedures / Q000009:adverse effects / Q000295:instrumentation* / Q000331:legislation & jurisprudence
D008670:Metals