The normal course of affairs at FDA meetings – advisory meetings and other kinds – is that government employees do not speak as private citizens and that center and division chiefs do not represent FDA at those meetings. For the second time in 16 months, this pattern was broken as Robert Smith, MD, a reviewer of radiological products at the Center for Devices and Radiological Health, took to the podium to present his views as a private citizen on the 510(k) program. (Medical Device Daily)

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)