New FDA Rule Reclassifies PTCA Catheters

Percutaneous transluminal coronary angioplasty (PTCA) catheters are switching classes.

In a move that could save devicemakers more than $1 million, the U.S. Food and Drug Administration (FDA) has reclassified standard PTCA catheters as Class II devices rather than Class III products. The rule, which took effect Oct. 8, gives these devices the ability to be launched on the market through the 510(k) approval process rather than through premarket approval (PMA) applications.

The effort to reclassify PTCA catheters originated with Cook Medical Inc. of Bloomington, Ind. The company asked the FDA to reclassify the catheters only when they are to be used for balloon dilation in clogged or narrowed arteries to help increase and improve blood flow. Members of an FDA panel considering the request voted 7-1 to reclassify the PTCA catheters as Class II devices, but the group did not recommend reclassifying PTCA catheters used to treat in-stent stenosis and/or post-deployment stent expansion.

“In order to reclassify the PTCA catheter in Class II, it is necessary that the proposed class have sufficient regulatory controls to provide reasonable assurance of safety and effectiveness of the device for its intended use,” the FDA wrote.

To ensure device safety and effectiveness, the panel recommended a guidance document, labeling and postmarket surveillance as special controls be used. “Special controls will diminish some of the risks to health associated with certain PTCA catheters,” the Federal Register stated. In addition, the FDA panel said that device tracking or post-approval studies may be unnecessary in this specific case. But, assessments of adverse event reports through medical device reporting is “sufficient to address adverse effects caused by these devices and is the least burdensome way to gather this data for PTCA catheters.”

The FDA claims the reclassification is in accordance with the federal Food, Drug and Cosmetic Act.