USA – Device Makers Call for Changes to FDA’s Biliary Stent Guidance

Medical device makers Boston Scientific and Cook are calling for changes to the US Food and Drug Administration’s (FDA) draft guidance on 510(k) submissions for metal expandable biliary stents.

The 27-page draft guidance, which was released in July, revises the agency’s 1998 guidance on expandable biliary stents and includes new recommendations for shelf life and packaging, MRI compatibility and non-clinical bench testing.

In comments submitted to the public docket for the guidance, the two companies call for technical changes to the guidance on a host of issues, including device description, product testing and the appropriate pathway for submitting changes to a device.

In its comments, Cook says that the indication described in the guidance for biliary stents is narrower than the regulatory definition of the devices, which does not restrict the use of biliary stents to “palliation of malignant structures.”…