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Cardiac Device Guidances Awaited: AF Ablation, PTCA Downclassification

This article was originally published in The Gray Sheet

Executive Summary

Downclassification of percutaneous transluminal coronary angioplasty catheters is viewed by FDA as ripe for collaborative guidance development

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Catheter guidance

Substantial equivalence of coronary and peripheral arterial diagnostic catheters to legally marketed predicate devices precludes the need for a premarket application, FDA says in a 1July 15 guidance for novel diagnostic catheters for vulnerable plaque. New catheters will be reviewed as Class II devices under 21 CFR 870.1200 Diagnostic Intravascular Catheters, unless they do not meet comparative safety and effectiveness characteristics related to materials, mechanical and thermal properties, patient population and risk assessment. FDA is working on a trial design guidance for cardiac ablation devices for atrial fibrillation, as well as the downclassification of percutaneous transluminal angioplasty catheters (2"The Gray Sheet" June 16, 2003, p. 13)...

Catheter guidance

Substantial equivalence of coronary and peripheral arterial diagnostic catheters to legally marketed predicate devices precludes the need for a premarket application, FDA says in a 1July 15 guidance for novel diagnostic catheters for vulnerable plaque. New catheters will be reviewed as Class II devices under 21 CFR 870.1200 Diagnostic Intravascular Catheters, unless they do not meet comparative safety and effectiveness characteristics related to materials, mechanical and thermal properties, patient population and risk assessment. FDA is working on a trial design guidance for cardiac ablation devices for atrial fibrillation, as well as the downclassification of percutaneous transluminal angioplasty catheters (2"The Gray Sheet" June 16, 2003, p. 13)...

Device Center Seeks Outside Expertise Through University Partnerships

Creation of a web site for the CDRH medical device fellowship program is among ongoing efforts at the device center as it strives to recruit more outside experts

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