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Medical device makers Boston Scientific and Cook are calling for changes to the US Food and Drug Administration’s (FDA) draft guidance on 510(k) submissions for metal expandable biliary stents.The 27-page draft guidance, which was released in July, revises the agency’s 1998 guidance on expandable biliary stents and includes new recommendations for shelf life and packaging, MRI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.”
Additionally, both companies suggest that FDA change its recommendations for corrosion testing. “The test methods listed in this guidance focus on electrochemical principles which are suited for metals only. These test methods do not account for what happens to the polymers that may be part of the biliary stent,” Cook writes. Both Cook and Boston Scientific point to ASTM 2129 as an appropriate alternative.
While the draft guidance notes that clinical evidence in humans is generally not required for biliary stents, Cook asks that FDA expand the guidance to include recommendations on testing in an animal model.
Cook also takes issue with FDA’s assertion in the draft guidance that modifications to biliary stents are not eligible to be reviewed under the Special 510(k) pathway.
“It appears that by not allowing biliary stents to be eligible for submission under the Special 510(k) paradigm that FDA is violating their own ‘Guiding Principles’ as detailed within the [Deciding When to Submit a 510(k) for a Change to an Existing Device] guidance,” Cook writes, noting that the draft guidance does not provide a “factual justification” for excluding the stents from the pathway.
Public Docket