Regulatory News In Brief
This article was originally published in The Gray Sheet
Executive Summary
FDA stent guidance: Agency releases 1guidance April 30 on non-clinical engineering tests and recommended labeling for intravascular stents and stent delivery systems. The document suggests what test data should be included and how data should be formatted. For example, the guidance makes testing recommendations regarding material composition, fatigue/durability, MRI safety and compatibility, crush and kink resistance, shelf-life and biocompatibility. The guidance covers self-expanding and balloon expandable stents used in coronary and peripheral arteries, as well as stents for other vascular indications; non-vascular stents and stents used in the intracranial vasculature are outside the scope of the guidance. Some of the recommendations are relevant to drug-eluting and biodegradable stents, but additional recommended tests for these devices are outlined in drug-eluting stent draft guidance, FDA notes. The document supersedes January 2005 guidance
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Regulatory News In Brief
Baxter warning letter: Firm's Renal division, maker of HomeChoice peritoneal dialysis systems, MiniCaps disconnect caps and transfer sets, and Xenium dialyzers, is cited in a June 3 1warning letter for failing to comply with Medical Device Reporting and Quality System regulations. Baxter's internal systems do not assure timely identification and evaluation of potential MDR events, and the firm failed to submit MDR reports within the required 30-day window, FDA said. In addition, the company's corrective and preventive action procedures were found lacking. Baxter has received nine device-related warning letters since 1997, according to FDA's warning letter database