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FDA Revises 1998 Guidance on 510(k)s for Biliary Stents

Posted 18 July 2018 | By Ana Mulero 

FDA Revises 1998 Guidance on 510(k)s for Biliary Stents

The US Food and Drug Administration (FDA) is revisiting 1998 guidance on metal expandable biliary stents to provide up-to-date recommendations for 510(k) submissions.
 
The 27-page draft guidance has a substantial amount of new recommendations compared to what was included in the past guidance, which in nine page merely outlined the recommended format.
 
“This draft guidance applies to metal expandable biliary stents indicated for [relief from narrowing of the bile duct due to a tumor] in the [structures responsible for emptying bile into the small intestine],” FDA said. Those indicated for treatment of benign structures or intended to be used in vasculature, tracheal/bronchial tubes or gastrointestinal regions fall outside the scope of the draft.
 
Newly added sections to the updated draft guidance, released on Tuesday, include 510(k) submission recommendations for shelf life and packaging; magnetic resonance compatibility for passive implants; and non-clinical bench testing—broken down into three subsections.
 
The draft offers examples of the types of information to include in 510(k)s, including tables that illustrate how to make a side-by-side comparison between a new and a predicate device and how to organize test summary information. Examples on how to conduct tests of certain balloons with mounted stents and of different stent designs are described in the draft as well.
 
The update also includes the first use of FDA-recognized consensus standards developed via the International Organization for Standardization (ISO) as there were “no performance standards or special controls for biliary stents” at the time of the 1998 guidance.
 
Under biocompatibility, for example, the draft guidance points out that “it may be appropriate to provide a reference to either a recognized consensus standard, or to a letter of authorization (LOA) for a device master file (MAF)” for certain materials used on biliary stents.
 
Further, the draft guidance points to a number of related FDA final guidance documents, including past format guidance on traditional and abbreviated 510(k) submissions.
 
Meanwhile, the abbreviated 510(k) pathway is being expanded at FDA’s Center for Devices and Radiological Health (CDRH) to allow for greater flexibility in demonstrating substantial equivalence through the use of standards and guidance documents. A key change under the expanded program involves linking device-specific guidance, such as on biliary stents, to device types deemed appropriate for use of the expanded program.
 
CDRH’s 2018 guidance development plan, revealed last December, indicates that many more policy updates will come to guidance documents finalized in 1988, 1998 and 2008.
 
Metal Expandable Biliary Stents - Premarket Notification (510(k) Submissions Draft Guidance for Industry and Food and Drug Administration Staff

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