FDA panel studies new PACS rules

Physicians are eager for latest technology

A Food and Drug Administrationadvisory panel has recommended changes to the way the agency regulatesdevices used in picture archiving and communication systems. Ifadopted, the revised regulations could make life easier for somePACS vendors, especially manufacturers of image storage devicesand communications systems.

The FDA's Medical Devices Advisory Committee met last monthto discuss the proposed changes (SCAN 8/10/94). The FDA currentlyhas no regulatory classification for PACS devices, which are regulatedas radiology accessories. Because of the segment's rapid growth,the agency has decided to create a separate classification forPACS, according to Robert Phillips of the Center for Devices andRadiological Health.

At the Aug. 29 meeting, the medical devices panel recommendedthat five categories be created for PACS devices:

** Picture archiving and communication systems;

** Image digitizers;

** Image communications devices;

** Image storage devices; and

** Image hard-copy devices, such as printers.

The panel recommended no significant change to regulation ofPACS, image digitizers and hard-copy devices. These will continueto be regulated as class II devices, which require 510(k) clearanceand must meet special regulatory controls.

The panel proposed that storage and communications devicesthat use nondestructive compression be regulated as class I devices,which are exempt from 510(k) clearance. Storage and communicationsdevices that use destructive compression, which can cause dataloss, will require 510(k) clearance, according to Phillips.

The panel forwarded its recommendations to the FDA, which willuse them to develop proposed regulations. After the proposed regulationsare published in the Federal Register, the agency will take publiccomment on the new rules, then develop final regulations, Phillipssaid.