WASHINGTON Neither snow nor tropical storms can stop officials at the FDA from speaking to physicians when given the chance. That was the scenario at the Transcatheter Cardiovascular Therapeutics symposium in September as the 10,000 attendees noticeably dwindled near the end of the meeting as Hurricane Isabel forced the District of Columbia to shutter its windows and doors.

Bram Zuckerman, MD, director of the center for cardiovascular devices within the Center for Devices and Radiological Health at the FDA, gave the few in attendance an update on the Medical Device User Fees and Modernization Act (MDUFMA). "Right now, hiring is our top priority, and the cardiovascular division of CDRH has the bulk of the PMAs and 510(k)s submitted to the FDA," he said.

The cardiovascular division, as well as other offices of CDRH, is encouraging both industry representatives and clinicians to join its Medical Device Fellowship Program. "The idea behind the program is to develop outside experts that can be called upon when the workload is beyond our internal capabilities," Zuckerman said. The FDA has identified experts from specialty associations, its own advisory panels and former employees of the agency, he said.

Steve Phurrough, director of the coverage and analysis group at the Centers for Medicare & Medicaid Services (CMS; Baltimore, Maryland), told the cardiologists that getting a device covered and reimbursed through Medicare starts at the clinical trial design phase. "The trial design does affect coverage. Our analysts, when determining if a device should be covered, looks to see if the trial was tested on patients that are typical of Medicare beneficiaries," he said.

Phurrough cautioned that CMS could render more coverage decisions similar to its policy for lung volume reduction surgery, which limits reimbursements to certain facilities deemed centers of excellence.

Although FDA and CMS are actively collaborating with device manufacturers on the regulatory approval process, it's up to each manufacturer to share data with both agencies, Phurrough noted. "Don't assume if you're involved in a trial that whatever you send to the FDA is shared with us unless you instruct the FDA that it's OK to share the information," he advised.

Kevin New, CDU Washington Editor