Standard percutaneous transluminal coronary angioplasty (PTCA) catheters for certain indications will now be classified as device class II (special controls) rather than class III (premarket approval) after an FDA’s decision last week published in the Federal Register. With the final rule, effective Oct. 8, these PTCA devices will have the ability to be launched on the market through the 510(k) clearance process rather than use of premarket approval applications (PMAs).
According to the FDA, a petition was submitted under section 513 (f)(3) from Cook Medical requesting that the PTCA catheters be reclassified to a class II device. Cook requested that the catheters be reclassified only when indicated for use for balloon dilation of hemodynamically significant coronary artery or bypass graft stenosis in patients with coronary ischemia in order to improve myocardial perfusion.
With the decision, device costs for PMA requirements will be lessened and device manufacturers will pay a 510(k) submission user fee that will total $4,007. According to the FDA, these costs would be less due to the fact that there is less documentation and clinical data needed to submit a 510(k) clearance
While FDA panel members voted seven to one in favor of reclassifying the PTCA devices as class II, they did not however recommend reclassifying PTCA catheters used to treat in-stent restenosis and/or post-deployment stent expansion, because of the fact that information on these uses is lacking.
“In order to reclassify the PTCA catheter into 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. “[S]pecial controls will diminish some of the risks to health associated with certain PTCA catheters,” the Federal Register stated.
Additionally, the panel said that device tracking or post-approval studies may be unnecessary in this specific case; however, the agency said that 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.”
According to the agency, this reclassification is in accordance with the Federal Food, Drug and Cosmetic Act.