FDA Updates Biliary Stent Clearance Guidance, Maintains Special 510(k) Exclusion
Executive Summary
The US FDA’s first revisions to its biliary stent guidance in more than two decades maintain substantial equivalence limitations that block the devices from the special 510(k) pathway. The restrictions are needed due to potential risks caused by off-label use of the stents in the vascular system, the agency says.
You may also be interested in...
Global Medtech Guidance Tracker: July 2019
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Twenty-five new guidance documents have been posted on the tracker since its last update.
Addition to Quest Alzheimer's Suite Looks For Biomarker P-Tau217
The test is being integrated into Quest’s AD-Detect portfolio for assessing the risk of Alzheimer’s. It is the third p-tau217 test to make news this month, after new breakthrough designations for Quanterix and Roche and Eli Lilly.
‘Core Pillars’ Of Safety And Innovation Take Center Stage In FDA Reports
The US FDA has issued a pair of reports focused on device safety and innovation. The reports describe recent steps the agency has taken to improve in the two areas, and what it plans to do next.