WASHINGTON — Tuesday served as the last day of CRT (Cardiovascular Research Technologies) 2010, sponsored by the Cardiovascular Research Institute (Washington), and included a lunchtime discussion session offering views of how healthcare reform might affect the device industry, but a previous session gave Jeffrey Shuren, MD, the chief of the Center for Devices and Radiological Health, a chance to further explain where he expects to steer the center in the next couple of years. (Medical Device Daily)

WASHINGTON – Monday's goings-on at CRT (Cardiovascular Research Technologies) 2010, sponsored by the Cardiovascular Research Institute (Washington), included an afternoon session during which a number of FDAers opted to use their microphone time to give a common-knowledge review of the functions of their offices. However, a round-table discussion offered some tidbits in exchange for the attendees' time, including a review of continued enrollment in device trials and issues in connection with harvesting of valves after the patient has expired. (Medical Device Daily)

WASHINGTON — The three-day agenda for CRT (Cardiovascular Research Technologies) 2010, sponsored by the Cardiovascular Research Institute (Washington) showed that most of the interest in cardiovascular is still in the "cardio" part of the vascular system, but at least one Sunday session refreshingly dealt with the vascularity of other parts of the body. (Medcial Device Daily)

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)