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Regulatory News In Brief

This article was originally published in The Gray Sheet

Executive Summary

PREDICT at borders: FDA hopes to have its new border inspection tool, Predictive Risk-Based Evaluation for Dynamic Import Compliance Targeting, up and running nationwide by spring, Commissioner Margaret Hamburg said Feb. 4. The IT system considers various characteristics to pinpoint shipments in need of more comprehensive inspection and items that are less risky. It has been piloted for food inspections since 2007 and more recently for device and drug shipments (1"The Gray Sheet" Oct. 19, 2009)

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Regulatory News In Brief

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and biodegradable stents, but additional recommended tests for these devices are outlined in drug-eluting stent draft guidance, FDA notes.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

Regulatory News In Brief

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

Regulatory News In Brief

FDA transparency with industry: FDA is collecting information on ways it can improve transparency with regulated industries, the third phase of its ongoing transparency initiative. FDA says it held three listening sessions with members of regulated industry on Jan. 21, 27 and 28 and will publish transcripts of those sessions on the dockets. The agency seeks public comment on issues raised during the meetings and on how it can improve regulatory training and education for industry; guidance development; channels of communication with industry routinely and during crises; useful and timely answers to industry questions; and communications with sponsors during application reviews. Comments are due April 12

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