General v. specific indications
This article was originally published in The Gray Sheet
Executive Summary
DCRD initiative to allow general use labeling for electrophysiology catheters may also be applicable to other well established technologies. The division plans to allow cardiac ablation catheters to use a general indication for treatment of arrhythmias, rather than requiring PMA supplements for each individual application (1"The Gray Sheet," Jan. 8, 2001, p. 6). "We're taking a good hard look at some of those technologies that may be 10, 15 or 20 years old and have multiple singular indications associated where can we bring them together to have a more generic indication for use," Dillard says. Grouping indications, "so that we're only looking at one application as opposed to multiple applications," will serve to decrease the division's workload