Yesterday's meeting with managers at the Center for Devices and Radiological Health at FDA to address the much-maligned 510(k) program painted a picture that had to be discouraging to industry for a couple of reasons. One is that FDA staff indicated that the center's reviewers are swamped with the several types of 510(k) applications and the other is that the "predicate tree" is described in data files at FDA that are often either incomplete or have been truncated, leaving a dead end trail for those inside and outside the agency who are attempting to flesh out the current state of affairs for a device type. (Medical Device Daily)