Catheter guidance
This article was originally published in The Gray Sheet
Executive Summary
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)...
You may also be interested in...
Cardiac Device Guidances Awaited: AF Ablation, PTCA Downclassification
Downclassification of percutaneous transluminal coronary angioplasty catheters is viewed by FDA as ripe for collaborative guidance development
Partisan Politics Returns To US FDA Congressional Oversight
The US FDA has stood out as an agency that tends to draw broad bipartisan support amid a generally rancorous and divided Congress. A House hearing, however, may be a sign that those days are over.
GLP-1 Coverage Restrictions In Medicare Part D Surge As Demand For Obesity Drugs Grows
A major shift from unfettered coverage to prior authorizations was recorded by MMIT over the past year for the leading GLP-1/GIP agonist diabetes drugs. Public interest in using the drugs off label for weight loss drove the change.