FDA to hold PACS classification hearing

August 15, 1994

The Food and Drug Administration'sCenter for Devices and Radiological Health will discuss the classificationof PACS devices at a hearing to be held Aug. 29. The hearing willbe conducted by the Medical Devices Advisory Committee's radiologicaldevices

The Food and Drug Administration'sCenter for Devices and Radiological Health will discuss the classificationof PACS devices at a hearing to be held Aug. 29. The hearing willbe conducted by the Medical Devices Advisory Committee's radiologicaldevices panel.

PACS devices do not have their own classification and insteadare categorized as radiology accessories for purposes of governmentregulation. The rapid growth of PACS suggests that the devicesbe given their own classification, according to Robert Phillipsof the CDRH.

The panel will also discuss minor changes to PACS regulation.For example, the FDA may ease off on requirements that storageand communication devices receive 510(k) clearance before theycan be marketed, Phillips said.

The FDA is seeking industry participation in the hearing, whichwill be held at 2:30 p.m. in Room G of the Parklawn building atthe FDA's headquarters at 5600 Fishers Lane in Rockville, MD.For more information call Phillips at 301/594-1212.