A Food and Drug Administration advisory panel is meeting today to review a premarket approval (PMA) application filed by GE Medical Systems of Waukesha, WI, for a full-field digital mammography system. The closely watched hearing should provide some indication as to whether full-field digital mammography will soon be available commercially in the U.S.
The hearing is being held by the radiological devices panel of the FDA's Medical Devices Advisory Committee, according to Robert Doyle, executive secretary of the committee. The panel will review clinical results GE has gathered in support of a PMA for its Senographe 2000D full-field digital system, which uses an amorphous silicon detector rather than conventional analog film-screen technology.
GE surprised the radiology community in late November when the company announced that it had filed a PMA for Senographe 2000D. The filing was the latest twist in an ongoing soap opera regarding the FDA's regulation of full-field digital mammography. The FDA had originally intended to review full-field devices using the less rigorous 510(k) process, but changed course earlier in the year because it was unhappy with the results being produced by the 510(k) process.
The panel will hear presentations from GE representatives and FDA reviewers who have examined the company's PMA data. The panel, consisting of mammography experts from around the U.S., will then make a recommendation to FDA reviewers. The GE system is the only item on the panel's agenda.
The panel can recommend that the PMA be approved, rejected, or approved with conditions, Doyle said. The recommendation is non-binding, and the FDA can ultimately choose whatever regulatory course it believes is necessary.
If the agency chooses to approve the PMA, a decision could be forthcoming as soon as a month after today's meeting, Doyle said. The quick turnaround is because GE's application has been granted expedited review status. The company filed the PMA on Oct. 29, according to GE representatives.
Interest in the panel meeting is running high, according to Doyle. The Medical Devices Advisory Committee usually meets at the headquarters of the Office of Device Evaluation in Rockville, MD, in a meeting room that accommodates about 70 people. But the agency moved today's meeting to a nearby hotel because it is expecting about 200 people to attend, Doyle said.
By Brian CaseyAuntMinnie.com staff writer
December 16, 1999
Copyright © 1999 AuntMinnie.com
