Devicemakers Critical of FDA Test Methods for Metal Biliary Stent PMAs

Boston Scientific and Cook Medical questioned parts of the FDA’s guidance on premarket notifications for metal expandable biliary stents and their delivery systems — including limits on eligibility for the Special 510(k) program and some recommended test methods in the draft released in July.

When the original 1998 guidance was drafted, the FDA had concerns about biliary stents being used off-label for vascular systems, which could cause harm due to lack of safety and efficacy data.

Metallic stents have since been approved for cardiovascular indications, but the agency still has concerns about use of the biliary stents for cardiovascular indications unless they have also been cleared for CV indications through a PMA.