The FDA issued a final rule reclassifying certain intra-aortic balloons and demanding more from others, according to a notice in the Federal Register.
The new rule eases regulation on intra-aortic balloons and pumps indicated for acute coronary syndrome, cardiac and non-cardiac surgery or complications of heart failure, lowering their classification from Class III to Class II.
The FDA maintained premarket approval application and product development protocol requirements for IABP devices when indicated for septic shock or pulsatile flow generation.
The rulings were based in part on a 2012 panel meeting, the results of which were circulated in June 2013 as a proposed rule which garnered just 1 public comment, the FDA said. That comment supported FDA’s proposal for stringent regulation of IABPs indicated for septic shock or pulsatile flow generation, but disagreed with the general down-classification of other devices.
Easing rules certain indications could create a loophole that would allow companies to bypass the premarket approval process by labeling their devices in such a manner that avoids more stringent review, the commenter warned.
"FDA disagrees with this comment," the agency said. "FDA does not regulate the practice of medicine but rather regulates the use of a device as indicated by the party offering the device for interstate commerce. The indications for IABP devices are limited by the codified classification."
IABPs consist of an inflatable balloon, which is placed in the aorta to improve cardiovascular functioning during certain life-threatening emergencies, and a control system for regulating the inflation and deflation of the balloon. The control system, which monitors and is synchronized with the electrocardiogram, provides a means for setting the inflation and deflation of the balloon with the cardiac cycle.